Home NDC 80801-103 DANDRUFF
Product NDC 80801-103
11-digit product format 808010103
Labeler code 80801
Product ID 80801-103_5b2fbb0b-57c6-59b7-e063-6394a90aa324
Type HUMAN OTC DRUG
Nonproprietary name pyrithione zinc
Dosage form SHAMPOO
Route TOPICAL
Labeler Primal Elements
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-01
Substance PYRITHIONE ZINC
Active strength .3 g/100mL
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 DANDRUFF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PYRITHIONE ZINC .3 g/100mL
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 20 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Structure of Skin Soothing Anti-Dandruff PYRITHIONE ZINC STRUCTURE OF SKIN LLC 3311fa83-a06b-b379-e063-6394a90ae269 2025-04-18 Warnings Exact identifier application number: M032 LILIVERA Hair Regrowth Kit MINOXIDIL Guangzhou Haishi Biological Technology Co., Ltd. 330602da-ec17-5a35-e063-6394a90a741b 2025-04-17 Warnings Exact identifier application number: M032 Head and Shoulders Clinical Strength Dry Scalp Rescue SELENIUM SULFIDE The Procter & Gamble Manufacturing Company 3272a482-3813-63e4-e063-6394a90a43eb 2025-04-10 Warnings Exact identifier application number: M032 XtraCare Anti-Dandruff Hair Cleanse for normal hair PYRITHIONE ZINC Rejoice International Inc. b90e574c-933c-4f86-aadc-567ffbe6ea04 2025-04-09 Warnings Exact identifier application number: M032 XtraCare Anti-Dandruff Hair Cleanse for sensitive hair PYRITHIONE ZINC Rejoice International Inc. 979394c2-5681-44c8-a43c-bf3a392bd0c1 2025-04-09 Warnings Exact identifier application number: M032 LEAHUE MADHUCA TONIC SALICYLIC ACID Bio-interchange Co. 31ee4645-0f64-f7a0-e063-6394a90a1736 2025-04-04 Warnings Exact identifier application number: M032 LEAHUE MADHUCA SALICYLIC ACID Bio-interchange Co. 81470dfe-f063-9d16-e053-2a91aa0a1829 2025-04-04 Warnings Exact identifier application number: M032 Kenkoderm Psoriasis Moisturizing SALICYLIC ACID Nexgel,Inc. 31ce20a2-95ae-e424-e063-6394a90af18a 2025-04-01 Warnings Exact identifier application number: M032 Kenkoderm Psoriasis SALICYLIC ACID Nexgel,Inc. 31cf90e5-0f21-903d-e063-6394a90a075d 2025-04-01 Warnings Exact identifier application number: M032 nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum PYRITHIONE ZINC The Wella Corporation 31af9365-e1a3-7203-e063-6294a90a8ade 2025-03-31 Warnings Exact identifier application number: M032 Listarfe Anti-Dandruff Shampoo. ANTI-DANDRUFF SHAMPOO Guangzhou Zanming Trading Co., Ltd. 3163eee0-379f-1f88-e063-6294a90a58ce 2025-03-28 Warnings Exact identifier application number: M032 anti dandruff SHAMPOOS PYRITHIONE ZINC Guangdong Quaker Daily Chemical Co., LTD 31392f0f-a6c4-1cfb-e063-6294a90a4d36 2025-03-26 Warnings Exact identifier application number: M032 anti dandruff SHAMPOOS PYRITHIONE ZINC Guangdong Quaker Daily Chemical Co., LTD 313716f7-6dd2-e1c5-e063-6394a90a9de3 2025-03-25 Warnings Exact identifier application number: M032 CeraVe Anti Dandruff Hydrating PYRITHIONE ZINC L'Oreal USA Products Inc 422e743b-fd77-40ed-8c5d-7f05112a447f 2025-03-24 Warnings Exact identifier application number: M032 Scalp Revival SALICYLIC ACID 3% Beccair, LLC 0a77e90e-a33a-43f3-80a0-a16a6902a735 2025-03-21 Warnings Exact identifier application number: M032 Gold Bond Psoriasis Relief Medicated Multi-Symptom SALICYLIC ACID Chattem, Inc. e8479bbc-5f49-41f2-851e-a93543516639 2025-03-19 Warnings Exact identifier application number: M032 13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and Mint PYRITHIONE ZINC Rejoice International Corp. 308554c2-938b-f0b5-e063-6394a90a5bfa 2025-03-17 Warnings Exact identifier application number: M032 13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa Butter PYRITHIONE ZINC Rejoice International Corp. 3086d31e-54ef-9c0f-e063-6394a90abdff 2025-03-17 Warnings Exact identifier application number: M032 SA Scalp Therapy SA SCALP Milbar Laboratories 304db1ab-acd7-43d5-e063-6294a90aeec2 2025-03-14 Warnings Exact identifier application number: M032 Neutrogena Scalp Therapy Anti-Dandruff Itchy Scalp SALICYLIC ACID Kenvue Brands LLC ca4c0d63-50b3-169f-e053-2a95a90acbcd 2025-03-10 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 80801-103-01 80801010301 355 mL in 1 BOTTLE, PLASTIC (80801-103-01) 355 ml 2023-10-01 No No Current