{"id":"dextromethorphan","rwe":[],"_fda":{"id":"3aa48604-afd3-49a2-b0a8-ab15171c7913","set_id":"0044c53c-11dd-41a9-a5d9-622dd8b1c144","openfda":{"upc":["0032251921049"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ"],"route":["ORAL"],"rxcui":["1113705"],"spl_id":["3aa48604-afd3-49a2-b0a8-ab15171c7913"],"brand_name":["Daytime Cold and Flu"],"spl_set_id":["0044c53c-11dd-41a9-a5d9-622dd8b1c144"],"package_ndc":["55319-960-08"],"product_ndc":["55319-960"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL"],"product_type":["HUMAN OTC DRUG"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"manufacturer_name":["Family Dollar (FAMILY WELLNESS)"],"application_number":["M012"],"is_original_packager":[true]},"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant"],"version":"3","stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition."],"warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may inclide: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"questions":["Questions or comments? Call 1 -877-753-3935 Monday-Friday 9AM-5PM EST"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema"],"do_not_use":["Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."],"when_using":["When using this product, do not exceed recommended dosage"],"effective_time":"20240327","active_ingredient":["Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg"],"inactive_ingredient":["Inactive ingredients acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate"],"indications_and_usage":["Uses temporarily relieves these symptoms due to a cold minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin."],"other_safety_information":["Other information each 30 mL contains : sodium 16 mg store between 20-25ºC (68-77ºF). Do not refrigerate."],"dosage_and_administration":["Directions do not take more than directed (see overdose warning ) do not take more than 6 doses (180 mL) in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours chlldren under 12 years of age: do not use"],"spl_product_data_elements":["Daytime Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ALCOHOL ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["Principal Display Panel COMPARE TO THE ACTIVE INGREDIENTS IN THERAFLU® EXPRESSMAX® DAYTIME SEVERE COLD & COUGH* ADULT DAYTIME SEVERE COLD & COUGH RELIEF Acetaminophen 650 mg Pain reliever; Fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCI 10 mg Nasal decongestion RELIEVES Cough Nasal congestion Sore throat Fever Body ache Headache Alcohol 10% For Ages 12 Years & Older BERRY FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® ExpressMax® Daytime Severe Cold & Cough. DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PKWY, CHESAPEAKE, VA 23320","Product Label FAMILY WELLNESS Adult Daytime Severe Cold & Cough Relief Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"3840 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"2294 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"1891 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1678 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1353 reports"},{"date":"","signal":"OVERDOSE","source":"FDA FAERS","actionTaken":"1305 reports"},{"date":"","signal":"DRUG ABUSE","source":"FDA FAERS","actionTaken":"1242 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"1214 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"1210 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"1164 reports"}],"drugInteractions":[],"commonSideEffects":[],"contraindications":["Achalasia of esophagus","Acidosis","Acute abdominal pain","Acute hepatitis","Acute nephropathy","Acute pancreatitis","Acute tuberculosis","Adrenal cortical hypofunction","Alcohol intoxication","Alcohol withdrawal delirium","Alcoholism","Anemia due to enzyme deficiency","Angle-closure glaucoma","Anuria","Arterial thrombosis","Arteriosclerotic vascular disease","Asthenia","Atony of colon","Autonomic dysreflexia","Azotemia","Benign intracranial hypertension","Benign prostatic hyperplasia","Bladder outflow obstruction","Bleeding","Bone marrow depression","Bradycardia","Brain damage","Breastfeeding (mother)","Bronchitis","Central nervous system depression","Chronic heart failure","Chronic idiopathic constipation","Chronic lung disease","Chronic obstructive lung disease","Coma","Complete atrioventricular block","Complete trisomy 21 syndrome","Conduction disorder of the heart","Congenital long QT syndrome","Constipation","Cor pulmonale","Coronary arteriosclerosis","Decreased respiratory function","Deficiency of cytochrome-b>5< reductase","Deficiency of glucose-6-phosphate dehydrogenase","Dehydration","Dependent drug abuse","Dermatitis herpetiformis","Diabetes mellitus","Disease of liver","Disorder of brain","Disorder of cardiovascular system","Disorder of coronary artery","Disorder of gallbladder","Disorder of the central nervous system","Disturbance of salivary secretion","Drowsy","Drug AND/OR toxin-induced diarrhea","Drug-induced psychosis","Dysfunction of sphincter of Oddi","Epilepsy","Exacerbation of asthma","Familial hyperkalemic periodic paralysis","Gastric ulcer","Gastrointestinal obstruction","Goiter","Hashimoto thyroiditis","Hepatic failure","Hiatal hernia","Hyperbilirubinemia","Hypercapnia","Hyperkalemia","Hypernatremia","Hypertensive disorder","Hypertensive urgency","Hyperthyroidism","Hypocalcemia","Hypocomplementemic urticarial vasculitis","Hypokalemia","Hypomagnesemia","Hyporeninemic hypoaldosteronism","Hypothyroidism","Hypoxia","Impaired renal function disorder","Inflammatory bowel disease","Injury of head","Kidney disease","Left heart failure","Left ventricular hypertrophy","Lesion of brain","Low blood pressure","Lowered convulsive threshold","Metabolic acidosis","Metabolic alkalosis","Methemoglobinemia","Mood swings","Morbid obesity","Myasthenia gravis","Myocardial dysfunction","Myocardial infarction","Neoplasm of brain","Neuroleptic malignant syndrome","Ocular hypertension","Oliguria","Operation on gastrointestinal tract","Paralytic ileus","Partial atrioventricular block","Peptic reflux disease","Peptic ulcer","Peripheral edema","Poisoning by acetaminophen","Pregnancy, function","Primary adrenocortical insufficiency","Prolonged QT interval","Pulmonary edema","Pulmonary emphysema","Pyloric obstruction","Retention of urine","Rhabdomyolysis","Seizure disorder","Severe chronic ulcerative colitis","Severe dehydration","Shock","Sleep apnea","Spastic paralysis","Substance abuse","Suicidal thoughts","Tachyarrhythmia","Thrombocytopenic disorder","Torsades de pointes","Toxic megacolon","Traumatic injury","Ulcerative colitis","Urethral stricture","Urinary tract obstruction","Ventricular tachycardia"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"approved","trials":["NCT03471767","NCT04044001","NCT01118858","NCT03505853","NCT03883581","NCT03948243","NCT00117715","NCT05944510","NCT00021697","NCT04797715","NCT02291666","NCT03738917","NCT02987920","NCT06348290","NCT00513864","NCT00741468","NCT03538054","NCT00788047","NCT04643249","NCT02062710","NCT01441986","NCT00401583","NCT00934466","NCT00127686","NCT00001725","NCT02515526","NCT00377403","NCT00467779","NCT02596360","NCT01767129","NCT01441102","NCT03792971","NCT05278494","NCT06930872","NCT01630811","NCT00050232","NCT00176553","NCT00001344","NCT05444556","NCT01091324","NCT01189097","NCT03381664","NCT02789527","NCT02153502","NCT00605605","NCT01584440","NCT00056524","NCT00999817","NCT07284472","NCT03195946"],"aliases":["Delsym","DXM","Robitussin DM (component)"],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-04-17","unitCost":"$0.1216/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$44","description":"DEXTROMETHORPHAN 15 MG SOFTGEL","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=dextromethorphan","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:47:10.490564+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:47:18.156707+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:47:09.128305+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=dextromethorphan","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:47:18.938165+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:47:07.247861+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:47:07.247911+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:47:20.459914+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL52440/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:47:19.415528+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M012","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:47:07.247918+00:00"}},"allNames":"delsym","offLabel":[],"timeline":[],"aiSummary":"Dextromethorphan is the most widely used OTC cough suppressant, available since 1958. Originally from Roche, it is a non-opioid antitussive found in hundreds of cold/cough products. Recent combinations (Nuedexta, Auvelity) have expanded its prescription use.","brandName":"Delsym","companyId":"unknown","ecosystem":[],"mechanism":{"target":"Taste receptor type 2 member 46, Solute carrier family 22 member 1, Cytochrome P450 2D6","novelty":"","modality":"Small molecule","drugClass":"Antitussive (non-opioid)","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:47:22.205266+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"Generic (originally Roche)","competitors":[],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"dextromethorphan","indications":{"approved":[{"name":"Allergic rhinitis","diseaseId":"allergic-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Common cold","diseaseId":"common-cold","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Cough","diseaseId":"cough","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Fever","diseaseId":"fever","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Headache disorder","diseaseId":"headache-disorder","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Influenza-like symptoms","diseaseId":"influenza-like-symptoms","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Major depressive disorder","diseaseId":"major-depressive-disorder","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Mouth Irritation","diseaseId":"mouth-irritation","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Nasal congestion","diseaseId":"nasal-congestion","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Nasal discharge","diseaseId":"nasal-discharge","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pseudobulbar affect","diseaseId":"pseudobulbar-affect","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Rhinitis","diseaseId":"rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Sneezing","diseaseId":"sneezing","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Sore throat symptom","diseaseId":"sore-throat-symptom","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Vasomotor rhinitis","diseaseId":"vasomotor-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03471767","phase":"Phase 2","title":"A Randomized, Double-Blind 4-Week Study to Evaluate the Impact of AXS-05 on Smoking Behavior","status":"COMPLETED","sponsor":"James Davis","isPivotal":false,"enrollment":58,"indication":"Smoking Cessation, Smoking, Cigarette","completionDate":"2019-03-31"},{"nctId":"NCT04044001","phase":"Phase 1","title":"A Prospective Phase Ib/IIa, Active-controlled, Randomized, Open-label Study to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of Multiple Oral Doses of BT","status":"COMPLETED","sponsor":"Michael Hoelscher","isPivotal":false,"enrollment":77,"indication":"Pulmonary Tuberculoses, Other Specified Pulmonary Tuberculosis","completionDate":"2022-05-31"},{"nctId":"NCT01118858","phase":"N/A","title":"Exogenous and Endogenous Biomarkers of CYP2D6 and CYP3A4 Variability in Pediatrics","status":"COMPLETED","sponsor":"Children's Mercy Hospital Kansas City","isPivotal":false,"enrollment":205,"indication":"Drug Metabolism Phenotype","completionDate":"2015-10"},{"nctId":"NCT03505853","phase":"Phase 1","title":"A Drug-Drug Interaction Study to Investigate the Effect of Givosiran on the Pharmacokinetics (PK) of Midazolam, Caffeine, Losartan, Omeprazole, and Dextromethorphan in Patients With Acute Intermittent","status":"COMPLETED","sponsor":"Alnylam Pharmaceuticals","isPivotal":false,"enrollment":10,"indication":"Acute Intermittent Porphyria (AIP), Acute Hepatic Porphyria (AHP)","completionDate":"2019-01-10"},{"nctId":"NCT03883581","phase":"Phase 1","title":"Impact of Nuedexta on Bulbar Physiology and Function in ALS","status":"COMPLETED","sponsor":"University of Florida","isPivotal":false,"enrollment":28,"indication":"Amyotrophic Lateral Sclerosis","completionDate":"2021-11-22"},{"nctId":"NCT03948243","phase":"Phase 1","title":"Licorice Botanical Dietary Supplements - Metabolism and Safety in Women","status":"COMPLETED","sponsor":"University of Illinois at Chicago","isPivotal":false,"enrollment":19,"indication":"Food-drug Interaction","completionDate":"2022-04-22"},{"nctId":"NCT00117715","phase":"N/A","title":"Developmental Regulation of CYPs 1A2, 2D6, 3A4","status":"COMPLETED","sponsor":"Children's Mercy Hospital Kansas City","isPivotal":false,"enrollment":121,"indication":"Healthy","completionDate":"2010-01"},{"nctId":"NCT05944510","phase":"Phase 4","title":"Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia: A Randomized, Group Sequential Adaptive Design, Controlled Clinical Trial","status":"COMPLETED","sponsor":"All India Institute of Medical Sciences, Bhubaneswar","isPivotal":false,"enrollment":40,"indication":"Treatment Resistant Schizophrenia","completionDate":"2025-04-30"},{"nctId":"NCT00021697","phase":"Phase 3","title":"A Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","isPivotal":true,"enrollment":100,"indication":"Amyotrophic Lateral Sclerosis","completionDate":"2002-04"},{"nctId":"NCT04797715","phase":"Phase 3","title":"A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type","status":"COMPLETED","sponsor":"Axsome Therapeutics, Inc.","isPivotal":true,"enrollment":178,"indication":"Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease","completionDate":"2022-11-21"},{"nctId":"NCT02291666","phase":"Phase 4","title":"Effects of Type 2 Diabetes on CYP450s Activities; Intersubject Variability in Drug Metabolism.","status":"COMPLETED","sponsor":"Centre hospitalier de l'Université de Montréal (CHUM)","isPivotal":false,"enrollment":73,"indication":"Type 2 Diabetes","completionDate":"2019-07"},{"nctId":"NCT03738917","phase":"Phase 4","title":"Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Uncomplicated Acute Bronchitis.","status":"COMPLETED","sponsor":"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina","isPivotal":false,"enrollment":668,"indication":"Acute Bronchitis","completionDate":"2021-12-31"},{"nctId":"NCT02987920","phase":"Phase 4","title":"A Randomized Double-blinded Study to Evaluate Preincisional Dextromethorphan in Patients Undergoing Total Knee Arthroplasty and Its Effect on Postoperative Opioid Use","status":"TERMINATED","sponsor":"University of Southern California","isPivotal":false,"enrollment":23,"indication":"Pain, Postoperative","completionDate":"2018-01"},{"nctId":"NCT06348290","phase":"Phase 1","title":"a Single-center, Non-randomized, Open-label, Self-controlled Phase 1 Clinical Study to Evaluate Drug-drug Interactions of JMKX001899 Tablets in Healthy Subjects","status":"UNKNOWN","sponsor":"Jemincare","isPivotal":false,"enrollment":72,"indication":"Solid Tumor, Adult","completionDate":"2024-09-15"},{"nctId":"NCT00513864","phase":"Phase 4","title":"Non-Invasive Assessment of Opioid Analgesia in Children With Sickle Cell Disease","status":"WITHDRAWN","sponsor":"Children's National Research Institute","isPivotal":false,"enrollment":0,"indication":"Sickle Cell Disease","completionDate":"2012-03"},{"nctId":"NCT00741468","phase":"Phase 1","title":"An Open-Label, Multiple-Dose, Non-Randomized Study to Assess the Drug-Drug Interactions of Proellex® (CDB-4124) With Cytochrome P450 Isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in Healthy Female Subjec","status":"COMPLETED","sponsor":"Repros Therapeutics Inc.","isPivotal":false,"enrollment":18,"indication":"Drug Interactions","completionDate":"2008-10"},{"nctId":"NCT03538054","phase":"Phase 2","title":"Dextromethorphan in Fibromyalgia","status":"COMPLETED","sponsor":"University of Alabama at Birmingham","isPivotal":false,"enrollment":27,"indication":"Fibromyalgia","completionDate":"2020-03-18"},{"nctId":"NCT00788047","phase":"Phase 1","title":"A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon [PF-01913539] On The Single-Dose Pharmacokinetics Of The CYP2D6 Substrate Dextromethorphan In ","status":"COMPLETED","sponsor":"Pfizer","isPivotal":false,"enrollment":14,"indication":"Huntington Disease, Alzheimer Disease","completionDate":"2009-01"},{"nctId":"NCT04643249","phase":"Phase 1","title":"A Phase I, Open-label, Fixed-sequence, Crossover, Drug-drug Interaction Study to Investigate the Inhibition Potential of KL1333 on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in Health","status":"COMPLETED","sponsor":"Abliva AB","isPivotal":false,"enrollment":14,"indication":"Mitochondrial Disease","completionDate":"2020-12-17"},{"nctId":"NCT02062710","phase":"Phase 4","title":"Antitussive Effect of a Naturally Flavored, Multi-Component Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo","status":"COMPLETED","sponsor":"Montefiore Medical Center","isPivotal":false,"enrollment":22,"indication":"Cough Reflex Sensitivity","completionDate":"2014-06"},{"nctId":"NCT01441986","phase":"Phase 2","title":"A Phase IIa, Double-blind, Placebo-controlled, Randomised, Fourfold Crossover Study to Investigate the Glucose Lowering Effects of Dextromethorphan and Amantadine in Subjects With Type 2 Diabetes Mell","status":"COMPLETED","sponsor":"Profil Institut für Stoffwechselforschung GmbH","isPivotal":false,"enrollment":20,"indication":"Type 2 Diabetes Mellitus","completionDate":"2012-05"},{"nctId":"NCT00401583","phase":"Phase 1","title":"A Multi-center, Open-Label, Multiple-probe Drug Interaction Study to Determine the Effects of GW786034 on the Metabolism of Cytochrome P450 Probe Drugs in Patients With Solid Tumors","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":24,"indication":"Carcinoma, Renal Cell","completionDate":"2008-02-20"},{"nctId":"NCT00934466","phase":"Phase 1","title":"A Randomized Clinical Trial to Assess the Effects of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability in Healthy Subjects","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":15,"indication":"Schizophrenia","completionDate":"2009-12"},{"nctId":"NCT00127686","phase":"Phase 1","title":"Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents","status":"COMPLETED","sponsor":"Penn State University","isPivotal":false,"enrollment":105,"indication":"Cough, Respiratory Tract Infections","completionDate":"2006-12"},{"nctId":"NCT00001725","phase":"Phase 2","title":"Clinical Trials in Orofacial Neuralgias","status":"COMPLETED","sponsor":"National Institute of Dental and Craniofacial Research (NIDCR)","isPivotal":false,"enrollment":100,"indication":"Facial Neuralgia, Pain","completionDate":"2002-01"},{"nctId":"NCT02515526","phase":"NA","title":"Effect of Acute Ethanol Consumption on The Activity of Major Cytochrome P450 Enzymes, NAT2 and P-glycoprotein","status":"COMPLETED","sponsor":"University of Cologne","isPivotal":false,"enrollment":16,"indication":"AOD Effects and Consequences","completionDate":"2015-08-27"},{"nctId":"NCT00377403","phase":"Phase 4","title":"Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study)","status":"COMPLETED","sponsor":"Washington University School of Medicine","isPivotal":false,"enrollment":172,"indication":"Acute Respiratory Infections, Acute Rhinosinusitis","completionDate":"2010-08"},{"nctId":"NCT00467779","phase":"Phase 1","title":"A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0973/XL518 Administered Orally Daily to Subjects With Solid Tumors","status":"COMPLETED","sponsor":"Genentech, Inc.","isPivotal":false,"enrollment":119,"indication":"Solid Tumor","completionDate":"2014-04"},{"nctId":"NCT02596360","phase":"Phase 1","title":"Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers","status":"COMPLETED","sponsor":"University Hospital, Clermont-Ferrand","isPivotal":false,"enrollment":20,"indication":"Experimental Pain, Hyperalgesia","completionDate":"2016-03"},{"nctId":"NCT01767129","phase":"Phase 2","title":"A Phase 2a, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Levodopa-induced Dyskinesia in","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","isPivotal":false,"enrollment":14,"indication":"Dyskinesia, Parkinson's Disease","completionDate":"2015-02-05"},{"nctId":"NCT01441102","phase":"Phase 1","title":"A Pilot Phase I/II Study for the Evaluation of Dextromethorphan as a Microglia Inhibitor in the Treatment of Diabetic Macular Edema (MiDME2)","status":"COMPLETED","sponsor":"National Eye Institute (NEI)","isPivotal":false,"enrollment":7,"indication":"Diabetic Macular Edema","completionDate":"2015-12"},{"nctId":"NCT03792971","phase":"Phase 1","title":"Phase 1, Open-label, One-arm, Fixed-sequence Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects","status":"COMPLETED","sponsor":"Galera Therapeutics, Inc.","isPivotal":false,"enrollment":13,"indication":"Healthy","completionDate":"2019-02-15"},{"nctId":"NCT05278494","phase":"NA","title":"A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan Compared to Placebo for the Treatment of Postoperative Pain","status":"RECRUITING","sponsor":"Nathanael Heckmann","isPivotal":false,"enrollment":160,"indication":"Post-operative Pain","completionDate":"2026-12-31"},{"nctId":"NCT06930872","phase":"Phase 1","title":"A Phase 1, Open Label, Drug Interaction Study to Evaluate the Effect of ZYN002 on the Pharmacokinetics of CYP3A4, CYP2C19, CYP2C9, CYP2D6, CYP1A2, CYP2C8, and CYP2B6 Probe Substrates, and Valproate in","status":"COMPLETED","sponsor":"Harmony Biosciences Management, Inc.","isPivotal":false,"enrollment":29,"indication":"Drug Interaction","completionDate":"2025-11-04"},{"nctId":"NCT01630811","phase":"Phase 2","title":"Nuedexta for Neurobehavioral Symptoms of Adults With Autism Spectrum Disorder","status":"COMPLETED","sponsor":"Sutter Health","isPivotal":false,"enrollment":13,"indication":"Autism","completionDate":"2015-12-15"},{"nctId":"NCT00050232","phase":"Phase 3","title":"","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","isPivotal":true,"enrollment":96,"indication":"Multiple Sclerosis","completionDate":"2004-06"},{"nctId":"NCT00176553","phase":"NA","title":"A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity","status":"TERMINATED","sponsor":"University of Medicine and Dentistry of New Jersey","isPivotal":false,"enrollment":20,"indication":"Neurotoxicity Syndromes","completionDate":"2007-05"},{"nctId":"NCT00001344","phase":"Phase 2","title":"Dextromethorphan Versus Placebo for Neuropathic Pain","status":"COMPLETED","sponsor":"National Institute of Dental and Craniofacial Research (NIDCR)","isPivotal":false,"enrollment":129,"indication":"Diabetic Neuropathies, Herpes Zoster","completionDate":"2001-02"},{"nctId":"NCT05444556","phase":"Phase 1","title":"The Effect of Imlunestrant on CYP2C8, CYP2C19, CYP2D6, P-gp, and BCRP Activity and the Effect of P-gp Inhibition on Imlunestrant Pharmacokinetics in Healthy Women of Non-childbearing Potential","status":"COMPLETED","sponsor":"Eli Lilly and Company","isPivotal":false,"enrollment":113,"indication":"Healthy","completionDate":"2022-11-02"},{"nctId":"NCT01091324","phase":"Phase 3","title":"The Reno-protective and Cardiovascular Effect of Dextromethorphan and Silymarin in Patients With Chronic Kidney Disease","status":"UNKNOWN","sponsor":"National Cheng-Kung University Hospital","isPivotal":true,"enrollment":45,"indication":"Proteinuria","completionDate":"2010-07"},{"nctId":"NCT01189097","phase":"Phase 3","title":"Combined Therapy of Methadone and Dextromethrophan: A Novel Strategy for the Treatment of Opioid Dependence","status":"UNKNOWN","sponsor":"National Cheng-Kung University Hospital","isPivotal":true,"enrollment":1500,"indication":"Opioid Abuse","completionDate":"2011-09"},{"nctId":"NCT03381664","phase":"Phase 1","title":"A Phase 1, Randomized, Single-Dose, 3-Way, Crossover Study to Compare the Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of AVP-923 (Dextromethorphan Hydrobromide and Quinidine Su","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","isPivotal":false,"enrollment":17,"indication":"Healthy Adult Male and Female Volunteers","completionDate":"2018-01-30"},{"nctId":"NCT02789527","phase":"NA","title":"Exploratory Study of the Variability, in Five Human Populations, of ADME (Administration, Distribution, Metabolism, Excretion) Genotypes and Phenotypes After the Intake of the \"Geneva Micrococktail\"","status":"COMPLETED","sponsor":"Estella S. Poloni","isPivotal":false,"enrollment":367,"indication":"Healthy","completionDate":"2017-04"},{"nctId":"NCT02153502","phase":"Phase 2","title":"A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deuterium Modified Dextromethorphan Hydrobromide/Quinidine Sulfa","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","isPivotal":false,"enrollment":206,"indication":"Depressive Disorder, Treatment-Resistant","completionDate":"2016-02"},{"nctId":"NCT00605605","phase":"Phase 4","title":"Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker","status":"COMPLETED","sponsor":"National Cheng-Kung University Hospital","isPivotal":false,"enrollment":40,"indication":"Atherosclerosis, Smoking","completionDate":"2005-12"},{"nctId":"NCT01584440","phase":"Phase 2","title":"A Phase 2, Randomized, Double-dummy, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of AVP-923 (Dextromethorphan/Quinidine) for the Treatment of Symptoms of Agi","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","isPivotal":false,"enrollment":220,"indication":"Agitation, Alzheimer's Disease","completionDate":"2014-07-30"},{"nctId":"NCT00056524","phase":"Phase 3","title":"An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","isPivotal":true,"enrollment":600,"indication":"Alzheimer's Disease, Stroke","completionDate":"2007-06"},{"nctId":"NCT00999817","phase":"Phase 1","title":"An Open Label Phase 1, Randomized Cross Over Trial To Estimate The Effect Of PF- 00299804 On The Pharmacokinetics Of Dextromethorphan In Healthy Volunteers","status":"COMPLETED","sponsor":"Pfizer","isPivotal":false,"enrollment":14,"indication":"Healthy Volunteers","completionDate":"2009-12"},{"nctId":"NCT07284472","phase":"Phase 2","title":"Phase 2/3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants With Alzheimer's Disease Dementia","status":"RECRUITING","sponsor":"Exciva GmbH","isPivotal":true,"enrollment":300,"indication":"Agitation Associated With Alzheimer's Disease Dementia","completionDate":"2029-02"},{"nctId":"NCT03195946","phase":"Phase 1","title":"Interventional, Open-label, Multiple-dose Study to Investigate the Effects of Multiple Doses of Lu AF35700 on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Dextromethorphan (CYP2D6), Caf","status":"COMPLETED","sponsor":"H. Lundbeck A/S","isPivotal":false,"enrollment":24,"indication":"Drug Reactions","completionDate":"2018-01-03"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Oral","frequency":"Every 4-12 hours","formulation":"Liquid, Capsule, Lozenge, Extended-release suspension"},"crossReferences":{"unii":"362O9ITL9D","rxcui":"3289","splId":"3aa48604-afd3-49a2-b0a8-ab15171c7913","chemblId":"CHEMBL52440","pubchemSID":"9162"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":3172,"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"firstApprovalDate":"1958-01-01","companionDiagnostics":[],"firstApprovalCountry":"United States","genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":4,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1982-10-08T00:00:00.000Z","mah":"RB HLTH","brand_name_local":"DELSYM","application_number":"NDA018658"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1984-04-02T00:00:00.000Z","mah":"ANI PHARMS","brand_name_local":null,"application_number":"NDA011265"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2014-07-15T00:00:00.000Z","mah":"PADAGIS US","brand_name_local":null,"application_number":"ANDA205292"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2016-09-20T00:00:00.000Z","mah":"ACELLA","brand_name_local":null,"application_number":"ANDA203375"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2018-03-05T00:00:00.000Z","mah":"PERRIGO R AND D","brand_name_local":null,"application_number":"ANDA207602"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-01-31T00:00:00.000Z","mah":"RB HLTH","brand_name_local":null,"application_number":"NDA021620"},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"Un","currency":"USD","price_amount":"44.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":9,"withResults":3},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:47:22.205266+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}