{"id":"benzalkonium","rwe":[{"pmid":"41900376","year":"2026","title":"Driving Antibiotic Resistance Evolution of E. coli by Three Commonly Used Disinfectants Under Concentration-Increasing Stress.","finding":"","journal":"Microorganisms","studyType":"Clinical Study"},{"pmid":"41893664","year":"2026","title":"Quaternary Ammonium Biocide Resistance in Non-Typhoidal Salmonella from Pig Carcasses.","finding":"","journal":"Veterinary sciences","studyType":"Clinical Study"},{"pmid":"41882371","year":"2026","title":"Biodegradation of benzalkonium chloride: effect of carbon substrate on microbial community structure and antimicrobial susceptibility.","finding":"","journal":"Biodegradation","studyType":"Clinical Study"},{"pmid":"41880181","year":"2026","title":"Differential and Sex-Specific Toxicity of Aspirated Quaternary Ammonium Compounds.","finding":"","journal":"Environmental science & technology","studyType":"Clinical Study"},{"pmid":"41869426","year":"2026","title":"Systemic Contact Dermatitis Triggered by Benzalkonium Chloride in Laundry Detergent A Case Initially Misdiagnosed as Eczema.","finding":"","journal":"Clinical, cosmetic and investigational dermatology","studyType":"Clinical Study"}],"_fda":{"id":"4bd51523-4ef1-19eb-e063-6294a90a84c8","set_id":"0001d1cf-f727-4875-a44f-5a51f7b617a4","openfda":{"unii":["F5UM2KM3W7"],"route":["TOPICAL"],"rxcui":["1046593"],"spl_id":["4bd51523-4ef1-19eb-e063-6294a90a84c8"],"brand_name":["Moisturizing Antibacterial"],"spl_set_id":["0001d1cf-f727-4875-a44f-5a51f7b617a4"],"package_ndc":["79903-165-50"],"product_ndc":["79903-165"],"generic_name":["BENZALKONIUM CHLORIDE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["BENZALKONIUM CHLORIDE"],"manufacturer_name":["Walmart Inc."],"application_number":["505G(a)(3)"],"is_original_packager":[true]},"purpose":["Purpose Antibacterial"],"version":"5","stop_use":["Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours"],"warnings":["Warnings For external use only: hands only"],"questions":["Questions? 1-888-287-1915"],"when_using":["When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water."],"effective_time":"20260227","active_ingredient":["Active ingredient Benzalkonium chloride 0.13%"],"inactive_ingredient":["Inactive ingredients water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, Citrus nobilis (mandarin orange) oil, Camellia sinensis leaf extract, Zingiber officinale (ginger) root oil, blue 1, yellow 5"],"indications_and_usage":["Use For handwashing to decrease bacteria on the skin"],"spl_unclassified_section":["DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 *This product is not manufactured or distributed by Colgate-Palmolive Company, owner of trademark Softsoap ® Antibacterial Hand Soap with Moisturizers Fresh Citrus* Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915. Made in the USA with domestic and imported ingredients Factory Certified Empty Before Recycling PLASTIC BOTTLE how2recycle.info"],"dosage_and_administration":["Directions wet hands apply palmful to hands scrub thoroughly rinse thoroughly"],"spl_product_data_elements":["Moisturizing Antibacterial Benzalkonium chloride WATER LAURAMINE OXIDE COCAMIDOPROPYL BETAINE LAURAMIDOPROPYLAMINE OXIDE SODIUM CHLORIDE MYRISTAMIDOPROPYLAMINE OXIDE GLYCERIN DISTEARETH-75 ISOPHORONE DIISOCYANATE PEG-150 DISTEARATE CITRIC ACID MONOHYDRATE EDETATE SODIUM SULISOBENZONE SODIUM BENZOATE MANDARIN OIL GREEN TEA LEAF GINGER OIL FD&C BLUE NO. 1 FD&C YELLOW NO. 5 BENZALKONIUM CHLORIDE BENZALKONIUM"],"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":["principal display panel NDC 79903-165-50 equate™ Compare to Softsoap ® Antibacterial Hand Soap with Moisturizers Fresh Citrus* active ingredient Citrus LIQUID HAND SOAP ANTIBACTERIAL With light moisturizers Helps kill harmful germs 50 FL OZ (1 QT 1 PT 2 FL OZ) 1.47 L image description image description"]},"tags":[{"label":"benzalkonium","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"D08AJ01","category":"atc"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Active","category":"status"},{"label":"Allergic otitis externa","category":"indication"},{"label":"Itching of ear","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":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Infective Agents, Local","category":"pharmacology"},{"label":"Detergents","category":"pharmacology"},{"label":"Pharmaceutic Aids","category":"pharmacology"},{"label":"Preservatives, Pharmaceutical","category":"pharmacology"},{"label":"Surface-Active Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"135 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"122 reports"},{"date":"","signal":"DRUG HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"122 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"120 reports"},{"date":"","signal":"PAIN IN EXTREMITY","source":"FDA FAERS","actionTaken":"119 reports"},{"date":"","signal":"THERAPY NON-RESPONDER","source":"FDA FAERS","actionTaken":"118 reports"},{"date":"","signal":"INFECTION","source":"FDA FAERS","actionTaken":"117 reports"},{"date":"","signal":"MUSCULOSKELETAL STIFFNESS","source":"FDA FAERS","actionTaken":"116 reports"},{"date":"","signal":"MUSCULOSKELETAL PAIN","source":"FDA FAERS","actionTaken":"115 reports"},{"date":"","signal":"JOINT SWELLING","source":"FDA FAERS","actionTaken":"114 reports"}],"commonSideEffects":[],"contraindications":["Anemia due to enzyme deficiency","Bacterial septicemia","Blister","Conduction disorder of the heart","Condyloma acuminatum","Decreased respiratory function","Deficiency of cytochrome-b>5< reductase","Deficiency of glucose-6-phosphate dehydrogenase","Denuded skin","Diabetes mellitus","Disease of liver","Heart block","Hypocupremia","Infection of skin AND/OR subcutaneous tissue","Inflammatory dermatosis","Methemoglobinemia","Open wound","Perforation of tympanic membrane","Peripheral vascular disease","Seizure disorder","Shock"],"specialPopulations":{"Pregnancy":"If pregnant or breast-feeding. ask health care professional before use."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BENZALKONIUM","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:47:36.868286+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:47:43.188809+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BENZALKONIUM","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:47:43.712093+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA 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Label","rawText":"505G(a)(3)","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:47:35.630038+00:00"}},"allNames":"benzododecinium","offLabel":[],"synonyms":["benzalkonium chloride","benzalkonium","benzyldodecyldimethylammonium chloride","benzododecinium"],"timeline":[],"aiSummary":"Benzododecinium, also known as benzalkonium, is a small molecule drug in the benzalkonium class. It is used to treat various conditions including allergic otitis externa, itching of the ear and skin, local anesthesia, minor skin wound pain, mouth irritation, otitis externa, and post-op ocular inflammation. The commercial status of benzododecinium is not explicitly stated, but it is likely available as a generic medication. Key safety considerations include its potential for skin and eye irritation. As a local anesthetic, benzododecinium works by blocking nerve signals to numb the affected area.","brandName":"Benzododecinium","ecosystem":[{"indication":"Allergic otitis externa","otherDrugs":[{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"pramocaine","slug":"pramocaine","company":"Sebela Ireland Ltd"}],"globalPrevalence":null},{"indication":"Itching of ear","otherDrugs":[{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"hydrocortisone","slug":"hydrocortisone","company":"Merck"},{"name":"pramocaine","slug":"pramocaine","company":"Sebela Ireland Ltd"},{"name":"zinc acetate","slug":"zinc-acetate","company":"Armour Pharm"}],"globalPrevalence":null},{"indication":"Itching of skin","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"allantoin","slug":"allantoin","company":""},{"name":"ammonium 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Irritation","otherDrugs":[{"name":"benzocaine","slug":"benzocaine","company":""},{"name":"cetylpyridinium","slug":"cetylpyridinium","company":""},{"name":"dextromethorphan","slug":"dextromethorphan","company":"Ani Pharms"},{"name":"dyclonine","slug":"dyclonine","company":""}],"globalPrevalence":null},{"indication":"Otitis externa","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"acetic acid","slug":"acetic-acid","company":"Hi Tech Pharma"},{"name":"chloramphenicol","slug":"chloramphenicol","company":"Parkedale"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"}],"globalPrevalence":null},{"indication":"Post-Op Ocular Inflammation","otherDrugs":[{"name":"bromfenac","slug":"bromfenac","company":"Bausch And Lomb Inc"},{"name":"cortisone 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anesthesia."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3017","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BENZALKONIUM","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BENZALKONIUM","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:51:58.862911","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:47:46.547740+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"cetylpyridinium","drugSlug":"cetylpyridinium","fdaApproval":"","relationship":"same-class"},{"drugName":"benzethonium","drugSlug":"benzethonium","fdaApproval":"","relationship":"same-class"}],"genericName":"benzalkonium","indications":{"approved":[{"name":"Allergic otitis externa","source":"DrugCentral","snomedId":405821001,"regulator":"FDA","eligibility":"children under 12 years of age should be supervised"},{"name":"Itching of ear","source":"DrugCentral","snomedId":699392007,"regulator":"FDA","eligibility":"no specific eligibility criteria mentioned"},{"name":"Itching of skin","source":"DrugCentral","snomedId":418363000,"regulator":"FDA","eligibility":"no specific eligibility criteria mentioned"},{"name":"Local anesthesia","source":"DrugCentral","snomedId":386761002,"regulator":"FDA","eligibility":"no specific eligibility criteria mentioned"},{"name":"Minor Skin Wound Pain","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"no specific eligibility criteria mentioned"},{"name":"Mouth Irritation","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"no specific eligibility criteria mentioned"},{"name":"Otitis externa","source":"DrugCentral","snomedId":3135009,"regulator":"FDA","eligibility":"children under 12 years of age should be supervised"},{"name":"Post-Op Ocular Inflammation","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"no specific eligibility criteria mentioned"},{"name":"Prevent Minor Bacterial Skin Infection","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"no specific eligibility criteria mentioned"},{"name":"Skin irritation","source":"DrugCentral","snomedId":367466007,"regulator":"FDA","eligibility":"no specific eligibility criteria mentioned"},{"name":"Suppression of the Gag Reflex","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Uveitis","source":"DrugCentral","snomedId":128473001,"regulator":"FDA","usPrevalence":null,"globalPrevalence":3040000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (8407119[PMID])"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"cetylpyridinium","brandName":"cetylpyridinium","genericName":"cetylpyridinium","approvalYear":"","relationship":"same-class"},{"drugId":"benzethonium","brandName":"benzethonium","genericName":"benzethonium","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05275686","phase":"PHASE2","title":"Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)","status":"RECRUITING","sponsor":"Cedars-Sinai Medical Center","startDate":"2022-04-20","conditions":["Eustachian Tube Dysfunction"],"enrollment":80,"completionDate":"2027-12-31"},{"nctId":"NCT07000877","phase":"PHASE4","title":"Nasal Decongestant to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having Anesthesia.","status":"RECRUITING","sponsor":"Telethon Kids 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