Home NDC 85593-121 Anti Dandruff
Product NDC 85593-121
11-digit product format 855930121
Labeler code 85593
Product ID 85593-121_599f2cce-0c28-d425-e063-6394a90a1565
Type HUMAN OTC DRUG
Nonproprietary name Ketoconazole
Dosage form SHAMPOO
Route TOPICAL
Labeler Guangzhou ChuanMa International Trading Co.,Ltd.
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-22
Substance KETOCONAZOLE
Active strength 1 g/100mL
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Anti Dandruff
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOCONAZOLE 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R9400W927I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240812 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join As I Am Dry and Itchy Scalp Care PYRITHIONE ZINC Salon Commodities, Inc. 71ea4820-4160-41c2-e053-2a95a90a127d 2024-10-09 Warnings Exact identifier application number: M032 As I Am Dry and Itchy Scalp Care Co Wash PYRITHIONE ZINC Salon Commodities, Inc. 71edee79-87ed-ff7c-e053-2995a90ae130 2024-10-09 Warnings Exact identifier application number: M032 Vanicream Z-Bar PYRITHIONE ZINC Pharmaceutical Specialties, Inc. 21c84000-5d08-ae53-e063-6294a90a2362 2024-10-03 Warnings Exact identifier application number: M032 Head and Shoulders Classic Clean Dandruff PYRITHIONE ZINC Navajo Manufacturing Company Inc 3886d51a-b946-4862-a237-e8232df95637 2024-10-02 Warnings Exact identifier application number: M032 CVS Daily Dandruff Anti-dandruff PYRITHIONE ZINC CVS Health 705f5ced-a245-42c8-a32f-baaddaa11c6e 2024-09-27 Warnings Exact identifier application number: M032 CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SALICYLIC ACID CVS Health bd32def7-b002-4e12-89ad-b7d13754d82a 2024-09-24 Warnings Exact identifier application number: M032 CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruff SELENIUM SULFIDE CVS Health cff51af6-84de-4ba5-ac99-9bc42a65c9a5 2024-09-24 Warnings Exact identifier application number: M032 VERB PRODUCTS Balance Relief Salicylic Acid Dandruff Clinical Strength SALICYLIC ACID Verb Products Inc. 18bddd16-e001-445c-9647-801defc1d527 2024-09-03 Warnings Exact identifier application number: M032 Denorex Severe Itch COAL TAR Neoteric Cosmetics, Inc. 213ccbc4-2f52-58b6-e063-6294a90ae248 2024-09-03 Warnings Exact identifier application number: M032 SORARESAL SALICYLIC ACID Summer Herbal Inc. af734362-057b-4011-bf4e-c4e4dd67f68c 2024-09-03 Warnings Exact identifier application number: M032 ion 2 in 1 anti-dandruff Anti-dandruff PYRITHIONE ZINC Arcadia Beauty Labs LLC 38631b45-b222-4a25-8180-25970dabdffc 2024-08-28 Warnings Exact identifier application number: M032 TopCare Therapeutic Anti-Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Topco Associates LLC 070a5249-0b37-4b7f-a55b-609a0d8504d2 2024-08-22 Warnings Exact identifier application number: M032 J1003005 Jason Dandruff Relief SULFUR, SALICYLIC ACID The Hain Celestial Group, Inc. 625e8306-78c4-3317-e053-2991aa0afe81 2024-07-31 Warnings Exact identifier application number: M032 Jason Dandruff Relief Treatment 2 in 1 ZINC PYRITHIONE The Hain Celestial Group, Inc 4afa1048-7a76-4562-8dcf-9252d5bfa48a 2024-07-31 Warnings Exact identifier application number: M032 Alba Natural Acnedote Astringent SALICYLIC ACID The Hain Celestial Group, Inc. 939f90e7-e1de-4ca3-a484-90f1b87797d6 2024-07-31 Warnings Exact identifier application number: M032 Matrix Biolage ScalpSync Antidandruff PYRITHIONE ZINC L'Oreal USA Products Inc 8564f2cf-b680-4e2c-8451-f345c9852c1a 2024-07-18 Warnings Exact identifier application number: M032 Pete and Pedro Control Anti Itch Dandruff COAL TAR PETE AND PEDRO LLC 34ec83c1-31b9-4ecc-8bd2-898fd85364ba 2024-07-02 Warnings Exact identifier application number: M032 VICHY LABORATOIRES DERCOS Selenium Sulfide Anti-Dandruff SELENIUM SULFIDE, MICRONIZED L'Oreal USA Products Inc deae26e0-53f0-442b-959c-0f925a102db0 2024-06-25 Warnings Exact identifier application number: M032 VICHY LABORATOIRES Dercos Selenium Sulfide Anti-dandruff SELENIUM SULFIDE, MICRONIZED PRODUCTOS CAPILARES L'OREAL SA 3fcb03fc-552a-4b02-981e-2ff84142da96 2024-06-25 Warnings Exact identifier application number: M032 Dercos Salicylic Acid Anti-Dandruff Serum SALICYLIC ACID PRODUCTOS CAPILARES L'OREAL SA 024f9299-ee6c-48e3-89e7-96b7db060c30 2024-06-20 Warnings Exact identifier application number: M032
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85593-121-01 85593012101 230 mL in 1 BOTTLE (85593-121-01) 230 ml 2026-08-22 No No Current