{"id":"benzocaine","rwe":[{"pmid":"41890381","year":"2026","title":"Comparative Analysis of Topical vs. Systemic Analgesics for Pain Control During Initial Orthodontic Alignment.","finding":"","journal":"Journal of pharmacy & bioallied sciences","studyType":"Clinical Study"},{"pmid":"41819644","year":"2026","title":"Analysis of cocaine samples from amnesty bins located at a major UK summer music festival over a 10-year period using both low-field benchtop NMR (60 MHz) and medium-field NMR (400 MHz) for comparison.","finding":"","journal":"Forensic science international","studyType":"Clinical Study"},{"pmid":"41808674","year":"2026","title":"Risk-Stratified Use of Topical and Infiltrative Local Anesthetics in High-Risk Dermatologic Surgery.","finding":"","journal":"Journal of surgery and research","studyType":"Clinical Study"},{"pmid":"41777243","year":"2026","title":"Lidocaine Injection Provides Superior Pain Relief Compared to 10-Minute BLT Topical Numbing in Women Undergoing Cannula-Based Aesthetic Procedures.","finding":"","journal":"Aesthetic surgery journal. Open forum","studyType":"Clinical Study"},{"pmid":"41773699","year":"2026","title":"Evolving Analytical Techniques for the Determination of Benzocaine and Its Metabolites: A Critical Review.","finding":"","journal":"Critical reviews in analytical chemistry","studyType":"Clinical Study"}],"_fda":{"id":"2f0c45da-c4f2-bd12-e063-6394a90aba99","set_id":"0007e3ea-882b-4000-8e70-2bcec2c08613","openfda":{"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"upc":["0049696717472"],"unii":["U3RSY48JW5","YUL4LO94HK"],"route":["TOPICAL"],"rxcui":["637518"],"spl_id":["2f0c45da-c4f2-bd12-e063-6394a90aba99"],"brand_name":["Thera Plus Maximum Strength Feminine Anti-Itch"],"spl_set_id":["0007e3ea-882b-4000-8e70-2bcec2c08613"],"package_ndc":["80684-142-00"],"product_ndc":["80684-142"],"generic_name":["BENZOCAINE, RESORCINOL"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"substance_name":["BENZOCAINE","RESORCINOL"],"pharm_class_epc":["Standardized Chemical Allergen [EPC]"],"manufacturer_name":["FOURSTAR GROUP USA, INC."],"application_number":["M017"],"is_original_packager":[true]},"purpose":["Purpose External Analgesic"],"version":"2","stop_use":["Stop use and ask a doctor if condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days. Do not apply over large areas of the body."],"warnings":["Warnings For external use only. When using this product avoid contact with the eyes. Stop use and ask a doctor if condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days. Do not apply over large areas of the body. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid contact with the eyes."],"effective_time":"20250226","active_ingredient":["Active ingredients Benzocaine 20% Resorcinol 3% Purpose External Analgesic"],"inactive_ingredient":["Inactive ingredientsa aloe barbadensis leaf juice, cetyl alcohol, cholecalciferol, edetate disodium, fragrance, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, lanolin, methylparaben, mineral oil, petrolatum, propylene glycol, retinol, sodium lauryl sulfate, sodium sulfite, tocopherol, water"],"indications_and_usage":["Uses temporarily relieves itching"],"spl_unclassified_section":["Drug Facts","Other information Store at 20° - 25° C (68° - 77° F)."],"dosage_and_administration":["Directions Adults and children 12 years and older: apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 to 4 times daily. Children under 12 years: ask a doctor."],"spl_product_data_elements":["Thera Plus Maximum Strength Feminine Anti-Itch BENZOCAINE, RESORCINOL ALOE VERA LEAF CETYL ALCOHOL CHOLECALCIFEROL EDETATE DISODIUM GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE ISOPROPYL PALMITATE LANOLIN METHYLPARABEN MINERAL OIL PETROLATUM PROPYLENE GLYCOL RETINOL SODIUM LAURYL SULFATE SODIUM SULFITE TOCOPHEROL WATER BENZOCAINE BENZOCAINE RESORCINOL RESORCINOL"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["Package Labeling: Outer Package"]},"tags":[{"label":"Standardized Chemical Allergen","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Sodium channel protein type 5 subunit alpha","category":"target"},{"label":"SCN5A","category":"gene"},{"label":"SCN1A","category":"gene"},{"label":"SCN10A","category":"gene"},{"label":"C05AD03","category":"atc"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Active","category":"status"},{"label":"Cough","category":"indication"},{"label":"Itching of skin","category":"indication"},{"label":"Local anesthesia","category":"indication"},{"label":"Minor Skin Wound Pain","category":"indication"},{"label":"Mouth Irritation","category":"indication"},{"label":"Prevent Minor Bacterial Skin Infection","category":"indication"},{"label":"Anesthetics","category":"pharmacology"},{"label":"Anesthetics, Local","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Central Nervous System Depressants","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Sensory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"METHAEMOGLOBINAEMIA","source":"FDA FAERS","actionTaken":"175 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"130 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"108 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"88 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"76 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"73 reports"},{"date":"","signal":"DRUG HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"73 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"68 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"67 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"64 reports"}],"commonSideEffects":[],"contraindications":["Alcoholism","Anemia","Anemia due to enzyme deficiency","Appendicitis","Bleeding hemorrhoids","Blood coagulation disorder","Body fluid retention","Breastfeeding (mother)","Cardiovascular event risk","Conduction disorder of the heart","Constipation","Decreased respiratory function","Deficiency of cytochrome-b>5< reductase","Deficiency of glucose-6-phosphate dehydrogenase","Dehydration","Denuded skin","Depressive disorder","Diabetes mellitus","Diaper rash","Diarrhea","Disease of liver","Disorder of cardiovascular system","Disorder of electrolytes","Disorder of mucous membrane","Disorder of skin"],"specialPopulations":{"Pregnancy":"Use in Pregnancy: Safe use of One Touch Advanced Gel has not beenestablished with respect to possible adverse effects upon fetal development.Therefore, OneTouch Advanced Gel should not be used during early pregnancy,unless in the judgement of physician, the potential benefits outweigh the un--known hazards. Routine precaution for the use of any topical anesthetic shouldbe observed when OneTouch Advanced Gel is used."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BENZOCAINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:49:09.967740+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:49:15.573417+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BENZOCAINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:49:15.954432+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":"2026-04-19T23:49:08.402014+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:49:08.402043+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:49:08.402049+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":"2026-04-19T23:49:17.468585+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL278172/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:49:16.663221+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M017","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:49:08.402051+00:00"}},"allNames":"norcaine","offLabel":[],"synonyms":["benzocaine","norcaine","4-Carbethoxyaniline","benzocaine hydrobromide","benzocaine hydrochloride","benzocaine HCl","benzocaine methanesulfonate","ethyl aminobenzoate","parathesin","americaine","benzocaine formate"],"timeline":[],"aiSummary":"Norcaine, also known as benzocaine, is a small molecule standardized chemical allergen that targets the sodium channel protein type 5 subunit alpha. It is used to treat various conditions including cough, skin irritation, local anesthesia, and minor skin wound pain. The commercial status of Norcaine is not explicitly stated, but it is likely available as a generic medication. Key safety considerations include potential allergic reactions and interactions with other medications. As a local anesthetic, Norcaine works by blocking pain signals to the brain.","brandName":"Norcaine","ecosystem":[{"indication":"Cough","otherDrugs":[{"name":"ammonium chloride","slug":"ammonium-chloride","company":"B Braun"},{"name":"benzonatate","slug":"benzonatate","company":"Pfizer"},{"name":"bromazine","slug":"bromazine","company":"Forest Labs"},{"name":"chlorcyclizine","slug":"chlorcyclizine","company":""}],"globalPrevalence":null},{"indication":"Itching of skin","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"allantoin","slug":"allantoin","company":""},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Local anesthesia","otherDrugs":[{"name":"amobarbital","slug":"amobarbital","company":""},{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"bupivacaine","slug":"bupivacaine","company":"Hospira"},{"name":"cetylpyridinium","slug":"cetylpyridinium","company":""}],"globalPrevalence":null},{"indication":"Minor Skin Wound Pain","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"allantoin","slug":"allantoin","company":""},{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"benzethonium","slug":"benzethonium","company":""}],"globalPrevalence":null},{"indication":"Mouth Irritation","otherDrugs":[{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"cetylpyridinium","slug":"cetylpyridinium","company":""},{"name":"dextromethorphan","slug":"dextromethorphan","company":"Ani Pharms"},{"name":"dyclonine","slug":"dyclonine","company":""}],"globalPrevalence":null},{"indication":"Prevent Minor Bacterial Skin Infection","otherDrugs":[{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"benzethonium","slug":"benzethonium","company":""},{"name":"dyclonine","slug":"dyclonine","company":""},{"name":"lidocaine","slug":"lidocaine","company":"Fresenius Kabi Usa"}],"globalPrevalence":null},{"indication":"Skin irritation","otherDrugs":[{"name":"allantoin","slug":"allantoin","company":""},{"name":"aluminum acetate","slug":"aluminum-acetate","company":"Bayer Pharms"},{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"benzethonium","slug":"benzethonium","company":""}],"globalPrevalence":null},{"indication":"Sore throat symptom","otherDrugs":[{"name":"codeine","slug":"codeine","company":"Ani Pharms"},{"name":"dextromethorphan","slug":"dextromethorphan","company":"Ani Pharms"},{"name":"pheniramine","slug":"pheniramine","company":"Alcon"}],"globalPrevalence":null}],"mechanism":{"target":"Sodium channel protein type 5 subunit alpha","novelty":"First-in-class","targets":[{"gene":"SCN5A","source":"DrugCentral","target":"Sodium channel protein type 5 subunit alpha","protein":"Sodium channel protein type 5 subunit alpha"},{"gene":"SCN1A","source":"DrugCentral","target":"Sodium channel protein type 1 subunit alpha","protein":"Sodium channel protein type 1 subunit alpha"},{"gene":"SCN10A","source":"DrugCentral","target":"Sodium channel protein type 10 subunit alpha","protein":"Sodium channel protein type 10 subunit alpha"},{"gene":"SCN11A","source":"DrugCentral","target":"Sodium channel protein type 11 subunit alpha","protein":"Sodium channel protein type 11 subunit alpha"},{"gene":"SCN2A","source":"DrugCentral","target":"Sodium channel protein type 2 subunit alpha","protein":"Sodium channel protein type 2 subunit alpha"},{"gene":"SCN3A","source":"DrugCentral","target":"Sodium channel protein type 3 subunit alpha","protein":"Sodium channel protein type 3 subunit alpha"},{"gene":"SCN4A","source":"DrugCentral","target":"Sodium channel protein type 4 subunit alpha","protein":"Sodium channel protein type 4 subunit alpha"},{"gene":"SCN7A","source":"DrugCentral","target":"Sodium channel protein type 7 subunit alpha","protein":"Sodium channel protein type 7 subunit alpha"},{"gene":"SCN8A","source":"DrugCentral","target":"Sodium channel protein type 8 subunit alpha","protein":"Sodium channel protein type 8 subunit alpha"},{"gene":"SCN9A","source":"DrugCentral","target":"Sodium channel protein type 9 subunit alpha","protein":"Sodium channel protein type 9 subunit alpha"}],"modality":"Small Molecule","drugClass":"Standardized Chemical Allergen [EPC]","explanation":"","oneSentence":"","technicalDetail":"Norcaine binds to the sodium channel protein type 5 subunit alpha, inhibiting the influx of sodium ions and preventing the depolarization of nerve cells, which ultimately blocks the transmission of pain signals to the brain."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/323","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BENZOCAINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BENZOCAINE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:57:15.681355","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:49:18.815638+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"lidocaine","drugSlug":"lidocaine","fdaApproval":"1948-11-19","patentExpiry":"May 10, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"tetracaine","drugSlug":"tetracaine","fdaApproval":"2005-06-23","genericCount":1,"patentStatus":"Off-patent — generic 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relieves pain caused by canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums."},{"name":"Prevent Minor Bacterial Skin Infection","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Skin irritation","source":"DrugCentral","snomedId":367466007,"regulator":"FDA","eligibility":null},{"name":"Sore throat symptom","source":"DrugCentral","snomedId":267102003,"regulator":"FDA","eligibility":null},{"name":"Suppression of the Gag Reflex","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Tinea Infections","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Tinea corporis","source":"DrugCentral","snomedId":84849002,"regulator":"FDA"},{"name":"Tinea pedis","source":"DrugCentral","snomedId":6020002,"regulator":"FDA","usPrevalence":null,"globalPrevalence":640000000,"prevalenceMethod":"curated","prevalenceSource":"BMC Public Health, 2025 (PMID:40993673)"}],"offLabel":[{"name":"Hypocalcemia","source":"DrugCentral","drugName":"BENZOCAINE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Impacted cerumen","source":"DrugCentral","drugName":"BENZOCAINE","evidenceCount":2,"evidenceLevel":"emerging"},{"name":"Indigestion","source":"DrugCentral","drugName":"BENZOCAINE","evidenceCount":3,"evidenceLevel":"emerging"},{"name":"Osteoporosis","source":"DrugCentral","drugName":"BENZOCAINE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Otalgia","source":"DrugCentral","drugName":"BENZOCAINE","evidenceCount":5,"evidenceLevel":"emerging"},{"name":"Postmenopausal osteoporosis","source":"DrugCentral","drugName":"BENZOCAINE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Renal Osteodystrophy with Hyperphosphatemia","source":"DrugCentral","drugName":"BENZOCAINE","evidenceCount":0,"evidenceLevel":"emerging"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"lidocaine","brandName":"lidocaine","genericName":"lidocaine","approvalYear":"1948","relationship":"same-class"},{"drugId":"tetracaine","brandName":"tetracaine","genericName":"tetracaine","approvalYear":"2005","relationship":"same-class"},{"drugId":"cinchocaine","brandName":"cinchocaine","genericName":"cinchocaine","approvalYear":"","relationship":"same-class"},{"drugId":"procaine","brandName":"procaine","genericName":"procaine","approvalYear":"1954","relationship":"same-class"},{"drugId":"pramocaine","brandName":"pramocaine","genericName":"pramocaine","approvalYear":"1976","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07105943","phase":"NA","title":"Manipulating Exercise Intensity and Affective Responses for Cardiac Rehabilitation Program Acute Coronary Syndrome 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