{"id":"minoxidil-5","_fda":{"id":"33bd946d-1816-b60b-e063-6294a90a63c1","set_id":"33bd946d-1815-b60b-e063-6294a90a63c1","openfda":{"nui":["N0000175379","N0000175564"],"unii":["6SO6U10H04","5965120SH1"],"route":["TOPICAL"],"rxcui":["2715603"],"spl_id":["33bd946d-1816-b60b-e063-6294a90a63c1"],"brand_name":["5% Minoxidil Hair Growth Sprays Serum"],"spl_set_id":["33bd946d-1815-b60b-e063-6294a90a63c1"],"package_ndc":["85304-002-01"],"product_ndc":["85304-002"],"generic_name":["MINOXIDIL 5%"],"product_type":["HUMAN OTC DRUG"],"pharm_class_pe":["Arteriolar Vasodilation [PE]"],"substance_name":["BIOTIN","MINOXIDIL"],"pharm_class_epc":["Arteriolar Vasodilator [EPC]"],"manufacturer_name":["Guangzhou Borderless Technology Co., Ltd."],"application_number":["505G(a)(3)"],"is_original_packager":[true]},"purpose":["Hair Regrowth Treatment"],"version":"1","stop_use":["Chest pain, rapid heartbeat, faintness, or dizziness occurs. Sudden, unexplained weight gain occurs. If unwanted facial hair growth occurs . If you do not see hair regrowth in 6 months."],"warnings":["Keep out of reach of children. For external use only."],"do_not_use":["Your hair loss is sudden and/or patchy. Your hair loss is associated with childbirth. You do not know the reason for your hair loss. You are under 18 years of age. Do not use on babies and children. Your scalp is red, inflamed, infected, irritated, or painful. You use other medicines on the scalp."],"when_using":["Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. Some people have experienced changes in hair color andlor texture. It takes time to regrow hair, Results may occur at 3 months with twice a day usage. For some men, youmay need to use this product for at least 6 months before you see results, The amount of hair regrowth isdifferent for each person. Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water."],"effective_time":"20250427","active_ingredient":["Minoxidil 5% Biotin 0.5%"],"inactive_ingredient":["Butylene Glycol Glycerin Alcohol Castor oil Dexpanthenol Water"],"indications_and_usage":["Use to regrow hair and beard"],"dosage_and_administration":["1.Make sure your hair and scalp are dry(no need to wash your hair before each use). 2.Apply 3-4 pumps of spray directly to the treated area of the scalp. 3.Gently massage into the scalp or thinning hair areas until absorbed. 4.Continued use is required to increase and maintain hair regrowth, Discontinuation may lead to hair loss"],"spl_product_data_elements":["5% Minoxidil Hair Growth Sprays Serum Minoxidil 5% MINOXIDIL MINOXIDIL GLYCERIN BIOTIN BIOTIN ALCOHOL CASTOR OIL BUTYLENE GLYCOL DEXPANTHENOL WATER"],"keep_out_of_reach_of_children":["Keep out of reach of children.lf swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away."],"package_label_principal_display_panel":["label1"]},"safety":{"boxedWarnings":[]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Minoxidil 5 %","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T06:52:06.896351+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T06:52:27.498338+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T06:52:12.244818+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Minoxidil 5 %","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T06:52:12.577860+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":"2026-04-20T06:52:05.631791+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:52:05.631829+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:52:20.483563+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:52:05.631833+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Sulfonylurea receptor 2, Kir6.2 opener","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T06:52:14.058825+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL802/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T06:52:13.712938+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"505G(a)(3)","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:52:05.631836+00:00"}},"_dailymed":{"setId":"4dc2850a-9a7e-660f-e063-6294a90afd94","title":"TACRUITF 5% MINOXIDIL WITH BIOTIN TOPICAL SOLUTION (MINOXIDIL) SOLUTION [GUANGZHOU BORDERLESS TECHNOLOGY CO., LTD.]"},"aiSummary":"Minoxidil 5% is a marketed topical solution primarily indicated for hair and beard regrowth, developed by Mohammed Abd El Mawgoud Amer. The key composition patent expires in 2028, providing a period of market exclusivity and potential revenue protection. The primary risk is the lack of reported key trial results and revenue data, which may limit investor confidence and market valuation.","mechanism":{"drugClass":"Arteriolar Vasodilator [EPC]"},"_scrapedAt":"2026-03-28T06:14:56.248Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T06:52:27.498412+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"id":"minoxidil-5-hair-and-beard-regrowth","name":"Hair and beard regrowth","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not specified","diagnosticRequired":null,"brandNameForIndication":""}]},"trialDetails":[{"nctId":"NCT07435012","phase":"PHASE3","title":"Androgenic Alopecia TH07 Clinical Trial","status":"RECRUITING","sponsor":"Triple Hair Inc","startDate":"2026-04","conditions":"Androgenic 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