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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage83080-121-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage83080-121-02IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage83080-121-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage83080-121-02IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage83080-121-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage83080-121-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage83080-121-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage83080-121-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage83080-121-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage83080-121-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage83080-121-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage83080-121-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage83080-121-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage83080-121-02UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage83080-121-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage83080-121-02UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83080-121-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83080-121-02UExcluded because listing certification expired0efc9e666f02…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
IngredientStrength
PYRITHIONE ZINC10 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R953O2RHZ5Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5b2d9f2-ff29-2da1-e053-2995a90a68f3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83080-121-012025-01-30C16284748780-12cef2736-93a9-d83d-e063-dadaa90ab31fEcocare Dandruff Shampoo
83080-121-022025-01-30C16284748780-12cef2736-93a9-d83d-e063-dadaa90ab31fEcocare Dandruff Shampoo

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83080-121ANTI-DANDRUFF (ZINC PYRITHIONE) SHAMPOO [MEERAY COSMETICS CO., LTD.]1Current NDC20230301_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 13 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Bare Minimal IngredientsPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company003c585f-9fda-c86e-e063-6394a90ae3772025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Dual Pack Smooth and SilkyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company19ad72ea-9a4b-0a35-e063-6394a90a91312025-12-31WarningsExact identifier
application number: M032
Head and Shoulders 2in1 MEN Citrus and CedarPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company20d361ff-4a53-c1d4-e063-6294a90a24be2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Aloe Vera Soothing Relief DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company27ebc90d-7171-ccac-e063-6394a90a1c172025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Aloe Vera Soothing Relief 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company27ec4d49-a783-cacd-e063-6394a90adbbe2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Moisturizing Avocado Oil 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company27eca9a6-1dc0-b18a-e063-6394a90a1f412025-12-31WarningsExact identifier
application number: M032
Aloe Coal by T SpruillPYRITHIONE ZINCT. Spruill LLC.31212e41-bb2d-4baa-e063-6294a90a8d322025-12-29WarningsExact identifier
application number: M032
DHS Body WashZINC PYRITHIONEPerson and Covey469f38ac-6a5f-9954-e063-6294a90a99e02025-12-23WarningsExact identifier
application number: M032
Quality Choice PsoriasisSALICYLIC ACIDChain Drug Marketing Association, Inc.469ffccf-f5d7-a6e0-e063-6294a90ab4532025-12-23WarningsExact identifier
application number: M032
Quality Choice TherapeuticSALICYLIC ACIDChain Drug Marketing Association, Inc.46a009be-936d-ceb0-e063-6294a90a48512025-12-23WarningsExact identifier
application number: M032
Nizoral PsoriasisSALICYLIC ACIDKramer Laboratories6ad7f931-5411-474b-a86e-b511811b7dc02025-12-23WarningsExact identifier
application number: M032
Nizoral Psoriasis ReliefSALICYLIC ACIDKramer Laboratories3f8bc77e-a5cf-469c-9733-22d3de33ef5a2025-12-23WarningsExact identifier
application number: M032
X20HAIR ANTI FUNGALFOLLICULITISSHAMPOOZINC PYRITHIONEGuangzhou Tata Biotechnology Co., Ltd.358c0dc3-2778-8aff-e063-6394a90a877c2025-12-22WarningsExact identifier
application number: M032
NTG T/Sal 3% Salicylic Acid Anti-Dandruff for Scalp Build Up ControlSALICYLIC ACIDKenvue Brands LLC3c11da1d-0b24-743a-e063-6394a90a06992025-12-22WarningsExact identifier
application number: M032
Neutrogena T/Sal Plus 3% Salicylic Acid Anti-Dandruff for Dry, Itchy Scalp ControlSALICYLIC ACIDKenvue Brands LLC3c149239-107b-238d-e063-6294a90ac1622025-12-22WarningsExact identifier
application number: M032
Quality Choice PsoriasisSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd4651cabb-98ee-a257-e063-6294a90afd3b2025-12-19WarningsExact identifier
application number: M032
Quality Choice TherapeuticSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd465215fc-3648-152c-e063-6294a90ad4882025-12-19WarningsExact identifier
application number: M032
RoyceDerm Tea Tree TherapeuticSALICYLIC ACID 3%RoyceDerm LLC46542754-2256-a23c-e063-6394a90a77952025-12-19WarningsExact identifier
application number: M032
Psoriasin In-Shower TreatmentCOAL TARKobayashi Healthcare International, Inc.bca8d3d7-5463-0bf9-e053-2a95a90a4e732025-12-19WarningsExact identifier
application number: M032
Head and Shoulders Green ApplePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companya296e74c-bc52-4406-a161-aff935288cd42025-12-18WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83080-121-0183080012101300 mL in 1 BOTTLE, PUMP (83080-121-01) 300 ml2026-06-08NoNoCurrent
83080-121-02830800121021000 mL in 1 BOTTLE, PUMP (83080-121-02) 1000 ml2026-06-08NoNoCurrent