{"id":"sodium-hypochlorite","rwe":[],"_fda":{"id":"4b0ae3e4-c66a-bbac-e063-6294a90a9ce8","set_id":"3d72b72c-2949-4eb6-b64c-6c4aef0eddd9","openfda":{"upc":["0304360946160"],"unii":["DY38VHM5OD"],"route":["TOPICAL"],"rxcui":["313049"],"spl_id":["4b0ae3e4-c66a-bbac-e063-6294a90a9ce8"],"brand_name":["Dakins Full"],"spl_set_id":["3d72b72c-2949-4eb6-b64c-6c4aef0eddd9"],"package_ndc":["0436-0946-16"],"product_ndc":["0436-0946"],"generic_name":["SODIUM HYPOCHLORITE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["SODIUM HYPOCHLORITE"],"manufacturer_name":["Century Pharmaceuticals, Inc."],"is_original_packager":[true]},"purpose":["Antimicrobial"],"version":"7","stop_use":["Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases."],"warnings":["For external use only."],"questions":["Questions or Comments ? (317) 849-4210 or 1-866-343-2576, Mon-Fri, 9AM to 4PM EST Century Pharmaceuticals, Inc. - Indianapolis, IN 46256"],"do_not_use":["Do not use if sensitive to chlorine compounds."],"effective_time":"20260217","active_ingredient":["Sodium Hypochlorite 0.50%"],"inactive_ingredient":["Purified Water, Sodium Bicarbonate, Sodium Hydroxide"],"storage_and_handling":["Other Information Store at room temperature. May bleach clothing. Keep container closed when not using."],"indications_and_usage":["Uses To prevent and treat infections of the skin and tissue. Pre and post surgery Cuts, abrasions and skin ulcers"],"dosage_and_administration":["Directions Pour on or apply to affected area. For wound management, use as an irrigant, cleanser, or the wetting agent for a wet-to-moist dressing. Apply once daily for lightly to moderately exudative wounds. Apply twice daily for highly exudative or highly contaminated wounds. Protect intact skin with a moisture barrier ointment or skin sealant as needed."],"spl_product_data_elements":["Dakins Full Sodium Hypochlorite SODIUM HYDROXIDE SODIUM BICARBONATE WATER SODIUM HYPOCHLORITE HYPOCHLORITE ION"],"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":["dakinsfull"]},"tags":[{"label":"sodium hypochlorite","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"D08AX07","category":"atc"},{"label":"Topical","category":"route"},{"label":"Extracorporeal","category":"route"},{"label":"Buccal","category":"route"},{"label":"Gel","category":"form"},{"label":"Liquid","category":"form"},{"label":"Solution","category":"form"},{"label":"Active","category":"status"},{"label":"Infection of skin AND/OR subcutaneous tissue","category":"indication"},{"label":"Preoperative disinfection of skin","category":"indication"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Disinfectants","category":"pharmacology"},{"label":"Noxae","category":"pharmacology"},{"label":"Oxidants","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"COMPLETED SUICIDE","source":"FDA FAERS","actionTaken":"30 reports"},{"date":"","signal":"HYPOTENSION","source":"FDA FAERS","actionTaken":"22 reports"},{"date":"","signal":"TOXICITY TO VARIOUS AGENTS","source":"FDA FAERS","actionTaken":"22 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"17 reports"},{"date":"","signal":"AGITATION","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"OEDEMA","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"SYNCOPE","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"14 reports"},{"date":"","signal":"HYPONATRAEMIA","source":"FDA FAERS","actionTaken":"14 reports"},{"date":"","signal":"PRODUCT USE IN UNAPPROVED INDICATION","source":"FDA FAERS","actionTaken":"14 reports"}],"commonSideEffects":[]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=SODIUM HYPOCHLORITE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:57:57.548084+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:58:26.469485+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:58:04.707132+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SODIUM HYPOCHLORITE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:58:05.553335+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:57:55.319053+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:58:19.709738+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:57:55.319127+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":"2026-04-20T01:58:07.511730+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1334078/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:58:06.466235+00:00"}},"allNames":["sodium hypochlorite","sodium hypochloride","sodium oxychloride"],"offLabel":[],"synonyms":["sodium hypochlorite","sodium hypochloride","sodium oxychloride"],"timeline":[],"aiSummary":"Sodium hypochlorite is a marketed antiseptic used to prevent and treat skin infections, with a key composition patent expiring in 2028. Its mechanism of releasing hypochlorous acid to kill bacteria provides a strong efficacy profile against a broad spectrum of microorganisms. The primary risk is competition from other same-class antiseptics, including hydrogen peroxide, tosylchloramide sodium, isopropanol, and ethanol, some of which have longer patent protection or earlier FDA approval.","approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"ecosystem":[{"indication":"Infection of skin AND/OR subcutaneous tissue","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"}],"globalPrevalence":null},{"indication":"Preoperative disinfection of skin","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","modality":"Small Molecule","drugClass":"sodium hypochlorite","explanation":"","oneSentence":"","technicalDetail":"Sodium hypochlorite (NaOCl) is a strong oxidizing agent that releases hypochlorous 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