{"id":"benzoic-acid","rwe":[],"_fda":{"id":"47e8083a-60e6-b517-e063-6294a90ac104","set_id":"09821e01-1135-e75c-e063-6294a90a3451","openfda":{"nui":["N0000175806","N0000175807"],"unii":["8SKN0B0MIM","F2R8V82B84","J50OIX95QV","T42P99266K","28A37T47QO"],"route":["ORAL"],"rxcui":["1037234","2670308"],"spl_id":["47e8083a-60e6-b517-e063-6294a90ac104"],"brand_name":["URIBEL TABS"],"spl_set_id":["09821e01-1135-e75c-e063-6294a90a3451"],"package_ndc":["0178-0745-01"],"product_ndc":["0178-0745"],"generic_name":["METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["BENZOIC ACID","HYOSCYAMINE SULFATE","METHENAMINE","METHYLENE BLUE","PHENYL SALICYLATE"],"pharm_class_epc":["Nitrogen Binding Agent [EPC]"],"pharm_class_moa":["Ammonium Ion Binding Activity [MoA]"],"manufacturer_name":["Mission Pharmacal Company"],"is_original_packager":[true]},"version":"4","warnings":["WARNINGS Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs, discontinue use immediately."],"overdosage":["OVERDOSE Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms. Administration of small doses of diazepam to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as necessary. If overdose is suspected, contact your local Poison Control Center or emergency room immediately. US residents can contact the US National Poison Hotline at 1-800-222-1222."],"description":["DESCRIPTION Uribel® Tabs for oral administration Each tablet contains: Methenamine .........................................................................................................................81.6 mg Benzoic Acid ..........................................................................................................................9.0 mg Phenyl Salicylate ...................................................................................................................36.2 mg Methylene Blue ......................................................................................................................10.8 mg Hyoscyamine Sulfate..............................................................................................................0.12 mg HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH, 5αH-tropan-3α-ol(-)- tropate(ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34 H 48 N 2 O 10 S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethyleneimine; Uritone; Urotropin. C 6 H 12 N 4 ; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16 H 18 ClN 3 S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13 H 10 O 3 ; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxychloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43°C. It is very slightly soluble in water and freely soluble in alcohol. BENZOIC ACID. [65-85-0] Benzenecarboxylic acid; Benzeneformic acid; Benzenemethanoic acid. C 7 H 6 O 2 ; mol wt 122.12, C 68.85%, H 4.95%, O 26.20%. Exists as white powder or crystals, scales or needles. It has a strong odor and is slightly soluble in alcohol; also soluble in volatile and fixed oils, slightly soluble in petroleum ether. Uribel Tabs contain inactive ingredients: Crospovidone, FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Rice Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc, and Titanium Dioxide."],"precautions":["PRECAUTIONS Cross sensitivity and/or related problems Patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers. Pregnancy/Reproduction (FDA Pregnancy Category C) Hyoscyamine and methenamine cross the placenta. Studies concerning the effect of hyoscyamine and methenamine on pregnancy and reproduction have not been done in animals or humans. Thus, it is not known whether Uribel Tabs cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Uribel Tabs should be given to a pregnant woman only if clearly needed. Breastfeeding Problems in humans have not been documented; however, methenamine and traces of hyoscyamine are excreted in breast milk. Accordingly, Uribel Tabs should be given to a nursing mother with caution and only if clearly needed. Prolonged use There have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential. Pediatric use Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids. Geriatric use Use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness or confusion. ADVERSE REACTIONS Cardiovascular: rapid heartbeat, flushing Central Nervous System: blurred vision, dizziness, drowsiness Genitourinary: difficult micturition, acute urinary retention Gastrointestinal: dry mouth, nausea and vomiting Respiratory: shortness of breath or trouble breathing Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing. This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and will subside after medication is stopped. Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal at 1-800-298-1087 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch. Drug interactions As a result of hyoscyamine's effects on gastrointestinal motility and gastric emptying, absorption of other oral medications may be decreased during concurrent use with this combination medication. Methylene blue inhibits a range of CYP isozymes in vitro, including 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4/5. This interaction could be more pronounced with narrow therapeutic index drugs that are metabolized by one of these enzymes (e.g., digoxin, warfarin, phenytoin, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus). However, the clinical relevance of these in vitro interactions is unknown. Urinary alkalizers and thiazide diuretics May cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde. Antimuscarinics: Concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications. Antacids/antidiarrheals Concurrent use may reduce absorption of hyoscyamine resulting in decreased therapeutic effectiveness. Concurrent use with antacids may cause urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde. Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine. Antimyasthenics Concurrent use with hyoscyamine may further reduce intestinal motility, therefore, caution is recommended. Ketoconazole and hyoscyamine may cause increased gastrointestinal pH. Concurrent administration with hyoscyamine may result in marked reduction in the absorption of ketoconazole. Patients should be advised to take this combination at least 2 hours after ketoconazole. Monoamine oxidase (MAO) inhibitors Concurrent use with hyoscyamine may intensify antimuscarinic side effects. Opioid (narcotic) analgesics may result in increased risk of severe constipation. Sulfonamides These drugs may precipitate with formaldehyde in the urine increasing the danger of crystalluria. Patients should be advised that the urine and/or stools may become blue to blue-green as a result of the excretion of methylene blue."],"how_supplied":["HOW SUPPLIED Uribel Tabs are blue tablets imprinted with “SAT” on one side and “109” on opposite side. NDC 0178-0745-01, bottle of 100 tablets."],"effective_time":"20260108","contraindications":["CONTRADICTIONS Hypersensitivity to any of the ingredients is possible. Risk benefits should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis, acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy)."],"storage_and_handling":["STORAGE Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature 20°-25°C (68°- 77°F). Keep in a cool, dry place. Keep container tightly closed. Keep this and all drugs out of reach of children."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY HYOSCYAMINE SULFATE is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout the body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Its biotransformation is hepatic. Its protein binding is moderate. METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70%-90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is almost completely (90%) excreted; of this at a pH of 5, approximately 20% is formaldehyde. Protein binding - some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at pH greater than 6.8. METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed by the gastrointestinal tract and rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged. PHENYL SALICYLATE releases salicylate, a mild analgesic for pain. BENZOIC ACID helps maintain an acid pH in the urine necessary for the degradation of methenamine."],"indications_and_usage":["INDICATIONS AND USAGE Uribel Tabs are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures."],"spl_unclassified_section":["URIBEL TABS Rx Only 100 Tablets"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults One tablet orally 4 times per day followed by liberal fluid intake. Older Children Dosage must be individualized by physician. Not recommended for use in children six years of age or younger."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE A dependence on the use of Uribel Tabs has not been reported and due to the nature of its ingredients, abuse of Uribel Tabs is not expected."],"spl_product_data_elements":["URIBEL TABS Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE TALC MAGNESIUM STEARATE SILICON DIOXIDE STEARIC ACID STARCH, RICE CROSPOVIDONE HYOSCYAMINE SULFATE HYOSCYAMINE PHENYL SALICYLATE PHENYL SALICYLATE METHENAMINE METHENAMINE METHYLENE BLUE METHYLENE BLUE CATION BENZOIC ACID BENZOIC ACID SAT;109"],"package_label_principal_display_panel":["PACKAGE LABEL Rx Only UBL030R1023 Distributed by: MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355 R0823 label"]},"tags":[{"label":"Nitrogen Binding Agent","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Nicotinate phosphoribosyltransferase","category":"target"},{"label":"NAPRT","category":"gene"},{"label":"DAO","category":"gene"},{"label":"Oral","category":"route"},{"label":"Topical","category":"route"},{"label":"Cloth","category":"form"},{"label":"Concentrate","category":"form"},{"label":"Cream","category":"form"},{"label":"Liquid","category":"form"},{"label":"Active","category":"status"},{"label":"Dermatomyositis","category":"indication"},{"label":"Hyperammonemia","category":"indication"},{"label":"Induratio penis plastica","category":"indication"},{"label":"Morphea","category":"indication"},{"label":"Pemphigus","category":"indication"},{"label":"Systemic sclerosis","category":"indication"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antifungal Agents","category":"pharmacology"},{"label":"Food Additives","category":"pharmacology"},{"label":"Food Preservatives","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"ELECTROCARDIOGRAM QT PROLONGED","source":"FDA FAERS","actionTaken":"10 reports"},{"date":"","signal":"CARDIAC ARREST","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"5 reports"},{"date":"","signal":"HAEMOLYSIS","source":"FDA FAERS","actionTaken":"5 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"DRUG HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"2 reports"}],"commonSideEffects":[],"contraindications":["Hypersensitivity to any of the ingredients.","Cardiac disease, including arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis.","Gastrointestinal tract obstructive disease.","Glaucoma.","Myasthenia gravis.","Acute urinary retention in obstructive uropathy, such as bladder neck obstruction due to prostatic hypertrophy."],"specialPopulations":{"Pregnancy":"FDA Pregnancy Category C. hyoscyamine and methenamine cross the placenta. Studies concerning the effect of hyoscyamine and methenamine on pregnancy and reproduction have not been done in animals or humans. Thus it is not known whether Hyophen (TM) tablets cause fetal harm when administered to pregnant woman or can affect reproduction capacity and should be given to pregnant woman only if clearly needed.","Geriatric use":"use with caution in elderly patients as they may respond to usual doses of hyoscyamine with exctextent, agitation, drowsiness or confusion.","Paediatric use":"infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=benzoic acid","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:02:05.637671+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:02:12.066472+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=benzoic acid","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:02:13.375802+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:02:01.268603+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:02:01.268664+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:02:37.990184+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:02:01.268678+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":"2026-04-20T00:02:15.600357+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3544877/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:02:14.245932+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:02:27.405920+00:00"}},"allNames":"benzeneformic acid","offLabel":[],"synonyms":["benzoic acid","benzenecarboxylic acid","benzeneformic acid","benzenemethanoic acid"],"timeline":[],"brandName":"Benzeneformic Acid","ecosystem":[{"indication":"Dermatomyositis","otherDrugs":[{"name":"azathioprine","slug":"azathioprine","company":"Prometheus Labs"}],"globalPrevalence":602496},{"indication":"Hyperammonemia","otherDrugs":[{"name":"lactulose","slug":"lactulose","company":""},{"name":"phenylacetic acid","slug":"phenylacetic-acid","company":"B Braun"},{"name":"sodium benzoate","slug":"sodium-benzoate","company":""}],"globalPrevalence":null},{"indication":"Induratio penis plastica","otherDrugs":[{"name":"collagenase","slug":"collagenase","company":"Advance Biofactures"}],"globalPrevalence":null},{"indication":"Morphea","otherDrugs":[],"globalPrevalence":null},{"indication":"Pemphigus","otherDrugs":[{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""}],"globalPrevalence":1440000},{"indication":"Systemic sclerosis","otherDrugs":[{"name":"bosentan","slug":"bosentan","company":"Actelion Pharms Ltd"},{"name":"rituximab","slug":"rituximab","company":"Genentech"}],"globalPrevalence":136000000}],"mechanism":{"target":"Nicotinate phosphoribosyltransferase","novelty":"First-in-class","targets":[{"gene":"NAPRT","source":"DrugCentral","target":"Nicotinate phosphoribosyltransferase","protein":"Nicotinate phosphoribosyltransferase"},{"gene":"DAO","source":"DrugCentral","target":"D-amino-acid oxidase","protein":"D-amino-acid oxidase"}],"moaClass":"Ammonium Ion Binding Activity","modality":"Small Molecule","drugClass":"Nitrogen Binding Agent [EPC]","explanation":"","oneSentence":"","technicalDetail":"Benzoic acid targets Nicotinate phosphoribosyltransferase, an enzyme involved in the synthesis of pyridine nucleotides, which are essential for various cellular processes. By inhibiting this enzyme, benzoic acid may modulate the levels of these nucleotides, leading to its therapeutic effects."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4664","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=benzoic%20acid","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=benzoic acid","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:52:54.048964","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:02:38.532339+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"dinoprostone","drugSlug":"dinoprostone","fdaApproval":"1977-08-23","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"estrone sulphate","drugSlug":"estrone-sulphate","fdaApproval":"1977-05-19","relationship":"same-target"},{"drugName":"fluorescein","drugSlug":"fluorescein","fdaApproval":"2020-03-09","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"ibuprofen","drugSlug":"ibuprofen","fdaApproval":"1974-09-19","patentExpiry":"Sep 30, 2029","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"probenecid","drugSlug":"probenecid","fdaApproval":"1951-04-26","genericCount":7,"patentStatus":"Off-patent — generic available","relationship":"same-target"}],"genericName":"benzoic acid","indications":{"approved":[{"id":"benzoic-acid-symptoms-of-irritative-voiding","name":"Symptoms of irritative voiding","dosing":null,"approvals":[],"diseaseId":"","eligibility":null,"pivotalTrial":null,"restrictions":[],"patientPopulation":null,"diagnosticRequired":null,"brandNameForIndication":"Benzeneformic Acid"},{"id":"benzoic-acid-relief-of-local-symptoms-in-lo","name":"Relief of local symptoms in lower urinary tract infections","dosing":null,"approvals":[],"diseaseId":"","eligibility":null,"pivotalTrial":null,"restrictions":[],"patientPopulation":null,"diagnosticRequired":null,"brandNameForIndication":"Benzeneformic Acid"},{"id":"benzoic-acid-relief-of-urinary-tract-sympto","name":"Relief of urinary tract symptoms from diagnostic procedures","dosing":null,"approvals":[],"diseaseId":"","eligibility":null,"pivotalTrial":null,"restrictions":[],"patientPopulation":null,"diagnosticRequired":null,"brandNameForIndication":"Benzeneformic Acid"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"dinoprostone","brandName":"dinoprostone","genericName":"dinoprostone","approvalYear":"1977","relationship":"same-target"},{"drugId":"estrone-sulphate","brandName":"estrone sulphate","genericName":"estrone sulphate","approvalYear":"1977","relationship":"same-target"},{"drugId":"fluorescein","brandName":"fluorescein","genericName":"fluorescein","approvalYear":"2020","relationship":"same-target"},{"drugId":"ibuprofen","brandName":"ibuprofen","genericName":"ibuprofen","approvalYear":"1974","relationship":"same-target"},{"drugId":"probenecid","brandName":"probenecid","genericName":"probenecid","approvalYear":"1951","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT04966507","phase":"PHASE2","title":"Antibacterial Mouthwash for Pharyngeal Gonorrhea Prevention","status":"COMPLETED","sponsor":"University of California, Los Angeles","startDate":"2022-02-17","conditions":["Gonorrhea"],"enrollment":89,"completionDate":"2025-12-12"},{"nctId":"NCT04657120","phase":"NA","title":"Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy","status":"COMPLETED","sponsor":"Leiden University Medical Center","startDate":"2019-06-01","conditions":["Pulmonary Embolism","Embolism","Embolism and Thrombosis","Vascular Diseases","Cardiovascular Diseases","Lung Diseases","Respiratory Tract Diseases","Cancer","Diagnosis"],"enrollment":698,"completionDate":"2025-08-23"},{"nctId":"NCT06170346","phase":"PHASE2","title":"Effect of Topical Agents With Various Antioxidant Containts on Photodamage Skin Induced","status":"COMPLETED","sponsor":"Universitas Padjadjaran","startDate":"2022-11-01","conditions":["Photodamaged Skin"],"enrollment":11,"completionDate":"2024-01-31"},{"nctId":"NCT04939623","phase":"PHASE2","title":"Novel Use of Probenecid to Alleviate Symptoms of Opioid Withdrawal","status":"RECRUITING","sponsor":"University of Calgary","startDate":"2023-10-31","conditions":["Chronic Pain","Drug Dependence of Morphine Type","Symptom, Withdrawal"],"enrollment":40,"completionDate":"2025-12-31"},{"nctId":"NCT00597909","phase":"PHASE2","title":"Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy","status":"TERMINATED","sponsor":"Amgen","startDate":"2007-12","conditions":["Hepatic Encephalopathy"],"enrollment":1,"completionDate":"2008-09"},{"nctId":"NCT03422900","phase":"NA","title":"Hyperglycemia in Patients with Stroke and Indication of Enteral Nutrition","status":"COMPLETED","sponsor":"Endocrinology and Clinical Nutrition Research Center, Spain","startDate":"2017-12-12","conditions":["Hyperglycaemia (Non Diabetic)","Enteral Feeding Intolerance","Stroke"],"enrollment":52,"completionDate":"2021-09-30"},{"nctId":"NCT05983302","phase":"PHASE2,PHASE3","title":"Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care","status":"RECRUITING","sponsor":"Mashhad University of Medical Sciences","startDate":"2023-08-20","conditions":["Wounds and Injuries"],"enrollment":40,"completionDate":"2024-03-20"},{"nctId":"NCT05738733","phase":"NA","title":"A Clinical Efficacy Study of MsChief Personal Lubricant in Healthy Female Subjects","status":"COMPLETED","sponsor":"NovoBliss Research Pvt Ltd","startDate":"2023-03-02","conditions":["Healthy Females"],"enrollment":138,"completionDate":"2023-05-30"},{"nctId":"NCT05833633","phase":"","title":"Study of Genotype and Phenotype Characterization in Duchenne Muscular Dystrophy With Small Mutations","status":"UNKNOWN","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","startDate":"2022-03-18","conditions":["Muscular Dystrophy, Duchenne"],"enrollment":25,"completionDate":"2024-06-30"},{"nctId":"NCT03190785","phase":"NA","title":"Benzoates - an Obesogenic Endocrine Disrupting Chemical","status":"COMPLETED","sponsor":"East Carolina University","startDate":"2017-07-01","conditions":["Obesity","Metabolic Syndrome"],"enrollment":20,"completionDate":"2021-04-01"},{"nctId":"NCT03510741","phase":"PHASE2","title":"Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.","status":"COMPLETED","sponsor":"Pakistan Institute of Living and Learning","startDate":"2019-01-01","conditions":["Schizophrenia","Schizophreniform Disorders","Schizoaffective Disorder"],"enrollment":64,"completionDate":"2021-03-30"},{"nctId":"NCT03180528","phase":"PHASE2","title":"Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer","status":"COMPLETED","sponsor":"Kavita Sarin","startDate":"2018-07-07","conditions":["Skin Basal Cell Carcinoma"],"enrollment":30,"completionDate":"2020-12-31"},{"nctId":"NCT03875859","phase":"PHASE2","title":"Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)","status":"TERMINATED","sponsor":"Kavita Sarin","startDate":"2019-12-12","conditions":["Squamous Cell Carcinoma"],"enrollment":4,"completionDate":"2021-01-30"},{"nctId":"NCT04886882","phase":"EARLY_PHASE1","title":"Topical Agents Containing Magnesium Sulfate & Wound Healing in the Rat Model","status":"UNKNOWN","sponsor":"Başakşehir Çam & Sakura City Hospital","startDate":"2021-03-22","conditions":["Wound Heal"],"enrollment":30,"completionDate":"2021-07-01"},{"nctId":"NCT02422485","phase":"PHASE1","title":"A 6 Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear Palsy","status":"COMPLETED","sponsor":"Adam Boxer","startDate":"2015-04","conditions":["Progressive Supranuclear Palsy"],"enrollment":10,"completionDate":"2019-12"},{"nctId":"NCT03757962","phase":"NA","title":"Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1","status":"COMPLETED","sponsor":"McMaster University","startDate":"2018-11-13","conditions":["Obesity"],"enrollment":6,"completionDate":"2019-07-16"},{"nctId":"NCT04022941","phase":"NA","title":"Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.","status":"COMPLETED","sponsor":"Institute of Liver and Biliary Sciences, India","startDate":"2017-04-01","conditions":["Chronic Liver Disease"],"enrollment":108,"completionDate":"2018-12-31"},{"nctId":"NCT02111200","phase":"NA","title":"Comparative Efficacy of Phenylbutyrate (PBA) vs. Benzoate in Urea Cycle Disorders","status":"COMPLETED","sponsor":"Baylor College of Medicine","startDate":"2014-09","conditions":["Urea Cycle Disorders, Inborn"],"enrollment":7,"completionDate":"2015-10"},{"nctId":"NCT01428466","phase":"PHASE1","title":"Japanese Phase 1 Study of GSK2585823","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-11-18","conditions":["Acne Vulgaris"],"enrollment":20,"completionDate":"2011-02-15"},{"nctId":"NCT01527123","phase":"PHASE1","title":"A Study to Evaluate the Pharmacokinetics of Benzoic Acid and Hippuric Acid After Topical Administration of GSK2585823 in Japanese Subjects With Acne Vulgaris","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-02-28","conditions":["Acne Vulgaris"],"enrollment":12,"completionDate":"2012-06-01"},{"nctId":"NCT01349205","phase":"NA","title":"Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study","status":"TERMINATED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2010-03","conditions":["Obstructive Sleep Apnea","Enlargement of Tonsil or Adenoid"],"enrollment":42,"completionDate":"2014-06"},{"nctId":"NCT01921374","phase":"NA","title":"Mother-caregivers of Children With Duchenne Muscular Dystrophy","status":"COMPLETED","sponsor":"Monica Levy Andersen","startDate":"2013-08","conditions":["Other Diseases or Conditions"],"enrollment":60,"completionDate":"2014-07"},{"nctId":"NCT02026947","phase":"PHASE2","title":"Sodium Benzoate for Treatment of Attenuated/Transient Psychosis. A Randomized Placebo-controlled Trial.","status":"WITHDRAWN","sponsor":"Niuvanniemi Hospital","startDate":"2014-02","conditions":["Attenuated or Transient Psychosis"],"enrollment":0,"completionDate":"2016-12"},{"nctId":"NCT01179945","phase":"NA","title":"Effects of a Food Preservative on Glucose Homeostasis","status":"COMPLETED","sponsor":"Boston Children's Hospital","startDate":"2010-08","conditions":["Overweight"],"enrollment":13,"completionDate":"2011-12"},{"nctId":"NCT01486511","phase":"","title":"Pulmonary Embolism After Liver Resection","status":"UNKNOWN","sponsor":"Beaujon Hospital","startDate":"2007-01","conditions":["Liver Disease","Pulmonary Embolism","Thrombophilia","Death"],"enrollment":500,"completionDate":"2012-01"},{"nctId":"NCT00624676","phase":"NA","title":"Efficacy and Tolerance of a Derivative of Salicylic Acid and 5% Benzoyl Peroxide in Facial Acne Vulgaris","status":"COMPLETED","sponsor":"Cosmetique Active International","startDate":"2006-01","conditions":["Acne Vulgaris"],"enrollment":80,"completionDate":"2006-08"},{"nctId":"NCT01207089","phase":"PHASE1","title":"To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of AZD8329","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2010-09","conditions":["Overweight","Healthy","Male"],"enrollment":45,"completionDate":"2010-12"},{"nctId":"NCT01225939","phase":"PHASE1","title":"A Study Conducted Over 3 Periods to Look at the Drug in the Body","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2010-11","conditions":["Type 2 Diabetes Mellitus"],"enrollment":18,"completionDate":"2010-12"},{"nctId":"NCT01303614","phase":"PHASE4","title":"Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice","status":"UNKNOWN","sponsor":"Consorci Sanitari de Terrassa","startDate":"2011-04","conditions":["Gynecological Pathology"],"enrollment":100,"completionDate":"2012-09"},{"nctId":"NCT00935662","phase":"PHASE1","title":"A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2009-07","conditions":["Healthy Men"],"enrollment":119,"completionDate":"2010-08"},{"nctId":"NCT00000180","phase":"PHASE1","title":"AIT-082 Phase 1B Study","status":"COMPLETED","sponsor":"National Institute on Aging (NIA)","startDate":"","conditions":["Memory Disorders"],"enrollment":0,"completionDate":"2005-06"},{"nctId":"NCT00853450","phase":"PHASE1","title":"Bleeding Time Study With AZD6482, Clopidogrel and ASA","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2009-02","conditions":["Antiplatelet Effect"],"enrollment":28,"completionDate":"2009-07"},{"nctId":"NCT00848666","phase":"NA","title":"Safety and Efficacy of a Novel Topical Therapy for Tinea Pedis (Athlete's Foot)","status":"UNKNOWN","sponsor":"Hillel Yaffe Medical Center","startDate":"2009-04","conditions":["Tinea Pedis"],"enrollment":100,"completionDate":""},{"nctId":"NCT00688714","phase":"PHASE1","title":"Study to Investigate Safety and Tolerability of a Single Dose of AZD6482","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2008-01","conditions":["Antiplatelet Effect"],"enrollment":49,"completionDate":"2008-05"},{"nctId":"NCT00004767","phase":"PHASE2","title":"Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders","status":"COMPLETED","sponsor":"National Center for Research Resources (NCRR)","startDate":"1985-01","conditions":["Amino Acid Metabolism, Inborn Errors"],"enrollment":20,"completionDate":""},{"nctId":"NCT00041795","phase":"PHASE2","title":"Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy","status":"COMPLETED","sponsor":"NeoTherapeutics","startDate":"2002-01","conditions":["Peripheral Nervous System Diseases","Chemotherapy-Induced Peripheral Neuropathy"],"enrollment":50,"completionDate":""}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Cloth, Concentrate, Cream, Liquid","formulations":[{"form":"CLOTH","route":"TOPICAL","productName":"Eyelids Wipes"},{"form":"CONCENTRATE","route":"TOPICAL","productName":"Anubis Barcelona"},{"form":"CREAM","route":"TOPICAL","productName":"Anubis Barcelona Vital Line"},{"form":"LIQUID","route":"ORAL","productName":"Dairy Allergen Mix"},{"form":"LOTION","route":"TOPICAL","productName":"Anubis Barcelona New Even"},{"form":"LOTION","route":"TOPICAL","productName":"Anubis Barcelona Total Hydrating"},{"form":"TABLET","route":"ORAL","productName":"Hyophen"}]},"crossReferences":{"NUI":"N0000146160","MMSL":"10005","NDDF":"002878","UNII":"8SKN0B0MIM","VUID":"4017799","CHEBI":"CHEBI:30746","VANDF":"4017799","RXNORM":"18989","UMLSCUI":"C0053225","chemblId":"CHEMBL3544877","ChEMBL_ID":"CHEMBL541","KEGG_DRUG":"D00038","DRUGBANK_ID":"DB03793","PDB_CHEM_ID":" BEZ","PUBCHEM_CID":"243","SNOMEDCT_US":"387350000","MESH_DESCRIPTOR_UI":"D019817"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":11562,"therapeuticAreas":["Dermatology"],"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"unknown","modality":"Small Molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:02:38.532339+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}