Home NDC 83080-121 Anti-Dandruff
Product NDC 83080-121
11-digit product format 830800121
Labeler code 83080
Product ID 83080-121_53bf66e2-2d2a-1769-e063-6394a90a9fbe
Type HUMAN OTC DRUG
Nonproprietary name Zinc Pyrithione
Dosage form SHAMPOO
Route TOPICAL
Labeler MEERAY COSMETICS CO., LTD.
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-08
Substance PYRITHIONE ZINC
Active strength 10 mg/100mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 83080-121-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 83080-121-02 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 83080-121-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 83080-121-02 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 83080-121-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 83080-121-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 83080-121-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 83080-121-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 83080-121-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 83080-121-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 83080-121-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 83080-121-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 83080-121-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 83080-121-02 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 83080-121-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 83080-121-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 83080-121-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 83080-121-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 PYRITHIONE ZINC 10 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R953O2RHZ5 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83080-121 ANTI-DANDRUFF (ZINC PYRITHIONE) SHAMPOO [MEERAY COSMETICS CO., LTD.] 1 Current NDC 20230301_f5b2d9f2-ff29-2da1-e053-2995a90a68f3.zip
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 23 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dermaharmony Face and Body PYRITHIONE ZINC D3 Development, Inc. bd72b53c-b22c-40d0-e053-2995a90af9c1 2024-12-20 Warnings Exact identifier application number: M032 Zinc Therapy PYRITHIONE ZINC D3 Development, Inc. 637851c6-ff4a-8bbc-e053-2991aa0a963c 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Zinc Therapy PYRITHIONE ZINC D3 Development, Inc. cb442483-b735-01a0-e053-2995a90aaff5 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Pyrithione Zinc with Shea Butter PYRITHIONE ZINC D3 Development, Inc. dc7ba02c-bdbd-5136-e053-2995a90ac545 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Tea Tree Bar PYRITHIONE ZINC D3 Development, Inc. e9d5eb14-1840-ae21-e053-2a95a90aa321 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Unscented Bar PYRITHIONE ZINC D3 Development, Inc. e9d66c9c-5fb1-0a90-e053-2a95a90ab7a4 2024-12-20 Warnings Exact identifier application number: M032 BYE-BYE CRADLE CAP PYRITHIONE ZINC Tubby Todd f4398ad2-7da5-aff0-e053-2995a90ae266 2024-12-12 Warnings Exact identifier application number: M032 NATURALTECH PURIFYING ANTI-DANDRUFF PYRITHIONE ZINC Davines S.p.A. 1f7e0265-0543-4ef9-addf-4d514d0eedfe 2024-12-11 Warnings Exact identifier application number: M032 NATURALTECH PURIFYING ANTI-DANDRUFF SELENIUM SULFIDE Davines S.p.A. 369a24fd-3882-4fad-b57a-45806090aff1 2024-12-11 Warnings Exact identifier application number: M032 Skin Renewing Cream SALICYLIC ACID Allure Labs b5ea8f33-8f18-7464-e053-2a95a90a39b2 2024-12-09 Warnings Exact identifier application number: M032 Skin Renewing Cream SALICYLIC ACID Allure Labs fa54cf42-3ba7-b7b3-e053-6394a90aa7a0 2024-12-09 Warnings Exact identifier application number: M032 Satinique Anti Dandruff Scalp and Hair SALICYLIC ACID Access Business Group LLC 03252c61-c51b-4e87-a06d-a61b8393704f 2024-12-09 Warnings Exact identifier application number: M032 Dry Skin Relief Bar SALICYLIC ACID CP Skin Health Group, Inc. eceb73b0-4c2f-4989-a3aa-a6553bc68252 2024-12-09 Warnings Exact identifier application number: M032 Head and Shoulders Dual Pack Green Apple PYRITHIONE ZINC The Procter & Gamble Manufacturing Company c8208bac-9d32-7694-e053-2a95a90a746c 2024-11-27 Warnings Exact identifier application number: M032 Vanicream PYRITHIONE ZINC Pharmaceutical Specialties, Inc. d124a093-f739-0666-e053-2995a90a52ed 2024-11-27 Warnings Exact identifier application number: M032 LEAHUE MADHUCA TONIC SALICYLIC ACID Bio-interchange Co. 81454c8a-ddcf-7cef-e053-2991aa0a53c2 2024-11-27 Warnings Exact identifier application number: M032 Hairitage Wash It Away Anti-Dandruff for Oily, Flaky Scalp SELENIUM SULFIDE Maesa, LLC. b09c3b0d-564e-45e4-b6ff-c1f0c12a9521 2024-11-13 Warnings Exact identifier application number: M032 Hairitage Wash It Away Anti-Dandruff for Dry, Flaky Scalp SELENIUM SULFIDE Maesa, LLC. fa5d4ee3-fbeb-4379-bbd3-2b5b2cc45430 2024-11-12 Warnings Exact identifier application number: M032 Marcs 2 in 1 Everyday Care Dandruff Anti-Dandruff PYRITHIONE ZINC Mark Glassman, Inc. 1daaa2c9-fbc7-4aa5-9772-e15710932066 2024-11-11 Warnings Exact identifier application number: M032 Marcs Dry Scalp Care Dandruff Anti-Dandruff PYRITHIONE ZINC Mark Glassman, Inc. ffab6ca6-7c8f-4080-836c-635a6ba3c0bb 2024-11-11 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 83080-121-01 83080012101 300 mL in 1 BOTTLE, PUMP (83080-121-01) 300 ml 2026-06-08 No No Current 83080-121-02 83080012102 1000 mL in 1 BOTTLE, PUMP (83080-121-02) 1000 ml 2026-06-08 No No Current