{"id":"chloroxylenol","rwe":[{"pmid":"41728368","year":"2025","title":"Antimicrobial functional ingredients used in hand hygiene products: a cross-sectional survey on regional e-commerce platforms in Wuhan area of China.","finding":"","journal":"Asian biomedicine : research, reviews and news","studyType":"Clinical Study"},{"pmid":"41477371","year":"2025","title":"Knowledge, Attitude, and Practices of Barbers on Hygiene and Prevention of Communicable Diseases.","finding":"","journal":"Cureus","studyType":"Clinical Study"},{"pmid":"41409988","year":"2025","title":"Comparative study of common over-the-counter wound care products against early and mature biofilms of antibiotic-resistant wound pathogens.","finding":"","journal":"JAC-antimicrobial resistance","studyType":"Clinical Study"},{"pmid":"41109105","year":"2025","title":"In vivo and in silico assessment of endocrine disruption in Clarias gariepinus exposed to methylparaben, chloroxylenol, and benzalkonium chloride.","finding":"","journal":"Aquatic toxicology (Amsterdam, Netherlands)","studyType":"Clinical Study"},{"pmid":"40961862","year":"2025","title":"Chloroxylenol disrupts Rana chensinensis tadpoles metabolic homeostasis via gut microbiota-dysregulated: A multi-omics perspective.","finding":"","journal":"Aquatic toxicology (Amsterdam, Netherlands)","studyType":"Clinical Study"}],"_fda":{"id":"453c0ae5-7e3a-b428-e063-6394a90a4b61","set_id":"00214c45-8453-49f5-b3e9-c3602fe96e20","openfda":{"unii":["0F32U78V2Q"],"route":["TOPICAL"],"rxcui":["413261"],"spl_id":["453c0ae5-7e3a-b428-e063-6394a90a4b61"],"brand_name":["Suds High Foaming Antiseptic Hand and Body Wash"],"spl_set_id":["00214c45-8453-49f5-b3e9-c3602fe96e20"],"package_ndc":["63830-876-06","63830-876-17","63830-876-24","63830-876-01","63830-876-03","63830-876-05","63830-876-07","63830-876-09","63830-876-10","63830-876-11","63830-876-12","63830-876-13","63830-876-14","63830-876-15","63830-876-28","63830-876-27","63830-876-55","63830-876-08","63830-876-16","63830-876-18","63830-876-19","63830-876-20","63830-876-35"],"product_ndc":["63830-876"],"generic_name":["CHLOROXYLENOL"],"product_type":["HUMAN OTC DRUG"],"substance_name":["CHLOROXYLENOL"],"manufacturer_name":["Pro chem, Inc."],"application_number":["M003"],"is_original_packager":[true]},"purpose":["Drug Facts Box OTC-Purpose Section Antiseptic"],"version":"4","stop_use":["Drug Facts Box OTC-Stop Use Section irritation and redness develop"],"warnings":["Drug Facts Box OTC-Warnings Section For external use only"],"when_using":["Drug Facts Box OTC-When Using Section do not get into eyes if contact occurs, rinse eyes thoroughly with water"],"effective_time":"20251205","active_ingredient":["Drug Facts Box OTC-Active Ingredient Section Chloroxylenol 0.3%"],"inactive_ingredient":["Drug Facts Box OTC-Inactive Ingredient Section water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, DMDM hydantoin, fragrance, methylchloroisothiazolinone, methylisothiazolinone, aloe barbadensis, acid red 1"],"indications_and_usage":["Drug Facts Box OTC-Indications & Usage Section for hand-washing to decrease bacteria on the skin"],"dosage_and_administration":["Drug Facts Box OTC-Dosage & Administration Section wet hands and forearms apply 5 milliliters (teaspoonful) or palmful to hands and forearms scrub thoroughly for 1 minute and rinse"],"spl_product_data_elements":["Suds High Foaming Antiseptic Hand and Body Wash CHLOROXYLENOL WATER PROPYLENE GLYCOL SODIUM LAURETH SULFATE DECYL GLUCOSIDE ACID RED 1 METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE DMDM HYDANTOIN ALOE VERA LEAF CHLOROXYLENOL CHLOROXYLENOL"],"keep_out_of_reach_of_children":["Drug Facts Box OTC-Keep Out of Reach of Children Section if swallowed, get medical help or contact a Poison Control Center right away"],"package_label_principal_display_panel":["Suds High Foaming Antiseptic Hand & Body Wash 6876 Suds High Foaming Antiseptic Hand & Body Wash product label"]},"tags":[{"label":"chloroxylenol","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"5-hydroxytryptamine receptor 2B","category":"target"},{"label":"HTR2B","category":"gene"},{"label":"MAOA","category":"gene"},{"label":"D08AE05","category":"atc"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Cloth","category":"form"},{"label":"Gel","category":"form"},{"label":"Active","category":"status"},{"label":"Antiseptic preparation","category":"indication"},{"label":"Anthelmintics","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Infective Agents, Local","category":"pharmacology"},{"label":"Antiparasitic Agents","category":"pharmacology"},{"label":"Antiplatyhelmintic Agents","category":"pharmacology"},{"label":"Disinfectants","category":"pharmacology"},{"label":"Schistosomicides","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"14 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"9 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"9 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"8 reports"},{"date":"","signal":"ERYTHEMA","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"RENAL FAILURE","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"WEIGHT DECREASED","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"FEELING ABNORMAL","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION","source":"FDA FAERS","actionTaken":"6 reports"}],"commonSideEffects":[]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CHLOROXYLENOL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:21:43.657671+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:21:49.433570+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CHLOROXYLENOL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:21:49.812624+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:21:42.414760+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:21:42.414782+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":"2026-04-20T00:21:51.266961+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL398440/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:21:50.512044+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M003","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:21:42.414786+00:00"}},"allNames":"benzytol","offLabel":[],"synonyms":["chloroxylenol sodium","chloroxylenol","benzytol","parametaxylenol"],"timeline":[],"approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Benzytol","ecosystem":[{"indication":"Antiseptic preparation","otherDrugs":[{"name":"boric acid","slug":"boric-acid","company":""},{"name":"ethanol","slug":"ethanol","company":"B Braun"},{"name":"hydrogen peroxide","slug":"hydrogen-peroxide","company":""},{"name":"isopropanol","slug":"isopropanol","company":""}],"globalPrevalence":null}],"mechanism":{"target":"5-hydroxytryptamine receptor 2B","novelty":"First-in-class","targets":[{"gene":"HTR2B","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2B","protein":"5-hydroxytryptamine receptor 2B"},{"gene":"MAOA","source":"DrugCentral","target":"Amine oxidase [flavin-containing] A","protein":"Amine oxidase [flavin-containing] A"}],"modality":"Small Molecule","drugClass":"chloroxylenol","explanation":"","oneSentence":"","technicalDetail":"Benzytol's mechanism of action is thought to involve the disruption of cellular membranes and the inhibition of key enzymes involved in microbial metabolism, ultimately leading to cell death and the prevention of infection."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3094","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CHLOROXYLENOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CHLOROXYLENOL","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T09:34:13.113514","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:21:52.566582+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"hexachlorophene","drugSlug":"hexachlorophene","fdaApproval":"1949-04-19","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"phenol","drugSlug":"phenol","fdaApproval":"","relationship":"same-class"},{"drugName":"triclosan","drugSlug":"triclosan","fdaApproval":"1997-07-11","relationship":"same-class"}],"genericName":"chloroxylenol","indications":{"approved":[{"name":"Antiseptic preparation","source":"DrugCentral","snomedId":261276004,"regulator":"FDA","eligibility":"No patient eligibility criteria specified"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"hexachlorophene","brandName":"hexachlorophene","genericName":"hexachlorophene","approvalYear":"1949","relationship":"same-class"},{"drugId":"phenol","brandName":"phenol","genericName":"phenol","approvalYear":"","relationship":"same-class"},{"drugId":"triclosan","brandName":"triclosan","genericName":"triclosan","approvalYear":"1997","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07496515","phase":"PHASE2","title":"Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia","status":"NOT_YET_RECRUITING","sponsor":"Jaeb Center for Health Research","startDate":"2026-06-01","conditions":["Pediatric Chalazia"],"enrollment":168,"completionDate":"2028-02-01"},{"nctId":"NCT07169461","phase":"NA","title":"Effectiveness of Low Level Light Therapy and Intense Pulse Light on Mite Count as Adjuntive Therapies in Demodex Blepharitis Using Artificial Intelligent Program (Ai-Demodex)","status":"ENROLLING_BY_INVITATION","sponsor":"Chulalongkorn University","startDate":"2025-01-16","conditions":["Demodex Blepharitis","Meibomian Gland Dysfunction (MGD)"],"enrollment":88,"completionDate":"2025-12-30"},{"nctId":"NCT04052841","phase":"NA","title":"Morphological Analysis of Meibomian Glands","status":"UNKNOWN","sponsor":"Zhongshan Ophthalmic Center, Sun Yat-sen University","startDate":"2020-10-12","conditions":["Meibomian Gland Dysfunction"],"enrollment":180,"completionDate":"2023-12-01"},{"nctId":"NCT04568213","phase":"PHASE3","title":"Hypochlorous Acid Disinfection Prior to Cataract Surgery","status":"COMPLETED","sponsor":"Loma Linda University","startDate":"2020-10-29","conditions":["Cataract","Endophthalmitis"],"enrollment":54,"completionDate":"2022-12-09"},{"nctId":"NCT04603222","phase":"NA","title":"Evaluation of SUMMIT BRUSH in Treatment of Blepharitis","status":"RECRUITING","sponsor":"University of Notre Dame","startDate":"2020-07-21","conditions":["Blepharitis"],"enrollment":60,"completionDate":"2022-07-18"},{"nctId":"NCT03079843","phase":"NA","title":"Particulate Matter, Blood Pressure, and the Sympathetic Nervous System","status":"COMPLETED","sponsor":"University of Michigan","startDate":"2017-04-07","conditions":["Air Pollution"],"enrollment":50,"completionDate":"2019-04-30"},{"nctId":"NCT03544710","phase":"NA","title":"Impact of Preoperative Bathing on Post Caesarean Section Surgical Site Infection","status":"COMPLETED","sponsor":"Mbarara University of Science and Technology","startDate":"2017-12-07","conditions":["Cesarean Wound Disruption With Postnatal Complication"],"enrollment":96,"completionDate":"2018-03-21"},{"nctId":"NCT02500758","phase":"NA","title":"Effectiveness of Preoperative Surgical Scrubbing Using Clorhexidine Digluconate and Parachlorometaxylenol (ECP)","status":"COMPLETED","sponsor":"Ricardo Becerro de Bengoa Vallejo","startDate":"2015-06","conditions":["Skin Diseases","Surgical Site Infection"],"enrollment":30,"completionDate":"2016-01"},{"nctId":"NCT01521507","phase":"NA","title":"Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye","status":"COMPLETED","sponsor":"TearScience, Inc.","startDate":"2012-01","conditions":["Meibomian Gland Dysfunction","Dry Eye"],"enrollment":200,"completionDate":"2014-01"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Topical","formulation":"Aerosol, Cloth, Gel","formulations":[{"form":"AEROSOL, FOAM","route":"TOPICAL","productName":"FRESH FOAM DISINFECTANT"},{"form":"AEROSOL, FOAM","route":"TOPICAL","productName":"KLEENFOAM"},{"form":"AEROSOL, FOAM","route":"TOPICAL","productName":"Simple Hygiene Antibacterial Hand"},{"form":"AEROSOL, FOAM","route":"TOPICAL","productName":"secure"},{"form":"CLOTH","route":"TOPICAL","productName":"MEDI-WIPES"},{"form":"CLOTH","route":"TOPICAL","productName":"VioNex Towelette"},{"form":"GEL","route":"TOPICAL","productName":"ANTIMICROBIALSOAP"},{"form":"GEL","route":"TOPICAL","productName":"Antibacterial"},{"form":"GEL","route":"TOPICAL","productName":"Antibacterial HandSoap with Moisturizer"},{"form":"GEL","route":"TOPICAL","productName":"Antibacterial Soap"},{"form":"GEL","route":"TOPICAL","productName":"Global Household Antibacterial Hand Orange"},{"form":"GEL","route":"TOPICAL","productName":"HANDSOAP"},{"form":"GEL","route":"TOPICAL","productName":"Instant Hand Sanitizer"},{"form":"GEL","route":"TOPICAL","productName":"Kung Fu Panda Hand Sanitizer"},{"form":"GEL","route":"TOPICAL","productName":"Mckesson Hand Cleanse and Soothe with Aloe"}]},"crossReferences":{"NUI":"N0000147580","MMSL":"4423","NDDF":"003140","UNII":"0F32U78V2Q","VUID":"4019458","CHEBI":"CHEBI:34393","VANDF":"4018914","INN_ID":"492","RXNORM":"20877","UMLSCUI":"C0055463","chemblId":"CHEMBL398440","ChEMBL_ID":"CHEMBL398440","KEGG_DRUG":"D03473","DRUGBANK_ID":"DB11121","PUBCHEM_CID":"2723","SNOMEDCT_US":"126151007","MESH_SUPPLEMENTAL_RECORD_UI":"C007027"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":183,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"DrugCentral","atcCode":"D08AE05","allCodes":["D08AE05"]},"biosimilarFilings":[],"recentPublications":[{"date":"2025 Dec","pmid":"41728368","title":"Antimicrobial functional ingredients used in hand hygiene products: a cross-sectional survey on regional e-commerce platforms in Wuhan area of China.","journal":"Asian biomedicine : research, reviews and news"},{"date":"2025 Nov","pmid":"41477371","title":"Knowledge, Attitude, and Practices of Barbers on Hygiene and Prevention of Communicable Diseases.","journal":"Cureus"},{"date":"2025 Dec","pmid":"41409988","title":"Comparative study of common over-the-counter wound care products against early and mature biofilms of antibiotic-resistant wound pathogens.","journal":"JAC-antimicrobial resistance"},{"date":"2025 Dec","pmid":"41109105","title":"In vivo and in silico assessment of endocrine disruption in Clarias gariepinus exposed to methylparaben, chloroxylenol, and benzalkonium chloride.","journal":"Aquatic toxicology (Amsterdam, Netherlands)"},{"date":"2025 Dec","pmid":"40961862","title":"Chloroxylenol disrupts Rana chensinensis tadpoles metabolic homeostasis via gut microbiota-dysregulated: A multi-omics perspective.","journal":"Aquatic toxicology (Amsterdam, Netherlands)"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":""},{"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},{"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":"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":"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":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:21:52.566582+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}