Zinc Pyrithione

Product NDC
70533-003
11-digit product format
705330003
Labeler code
70533
Product ID
70533-003_ed87ccb5-6550-1702-e053-2995a90a2f8b
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Pyrithione
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Harry's Inc.
Application
M032
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-10-01
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70533-003DDiscontinued by firm2026-10-12
excluded packagepackage70533-00370533-003-02DDiscontinued by firm2026-10-12
excluded packagepackage70533-00370533-003-14DDiscontinued by firm2026-10-12

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70533-003-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70533-003-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70533-003-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70533-003-14367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70533-003-02Zinc Pyrithione59 mL in 1 TUBESHAMPOO596
70533-003-14Zinc Pyrithione414 mL in 1 BOTTLESHAMPOO4146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70533-003ZINC PYRITHIONE SHAMPOO [HARRY'S INC.]6Legacy NDC, 2 package rows20241219_a4fecf11-dd44-a06e-e053-2995a90afacf.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 21 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Scalp Therapy Anti-Dandruff Extra StrengthSALICYLIC ACIDKenvue Brands LLCca49fd70-f0d3-3375-e053-2a95a90af8352025-03-10WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Coastal TidePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company20d3208c-d22b-84f1-e063-6394a90ab6102025-03-06WarningsExact identifier
application number: M032
Head and Shoulders Supreme Nourish and Smooth ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86abb2ee-6b35-32eb-e053-2a91aa0a8bc62025-03-03WarningsExact identifier
application number: M032
Cantu Guava Ginger Anti DandruffSALICYLIC ACIDPDC Brandsd43a540b-bea5-2055-e053-2995a90a25fb2025-03-03WarningsExact identifier
application number: M032
Head and Shoulders 2in1 MenTimber Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2d7ff3d8-d142-9537-e063-6294a90ab02c2025-02-06WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Clinical Strength Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company2d041983-5750-e0f1-e063-6394a90a5b9e2025-01-31WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Vanilla and AmberPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cf441e0-3ddd-0f9e-e063-6394a90a092c2025-01-30WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Advanced Series Full and ThickPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7d3f0664-a9e7-6b63-e053-2991aa0a4b0a2025-01-29WarningsExact identifier
application number: M032
Head and Shoulders Dry Scalp Care Dual PackPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cdb1e94-3923-84f7-e063-6394a90a07d52025-01-29WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Itchy Scalp ReliefPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cc7724c-a1f1-a42d-e063-6394a90a83cf2025-01-28WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Advanced Series Swagger Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7d3cca83-f99e-2c30-e053-2991aa0a4c9d2025-01-28WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Advanced Oil ControlSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company2ccaceed-9928-ef05-e063-6394a90a65112025-01-28WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Soothing HydrationPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company003d1723-1fd9-ef2b-e063-6294a90aafda2025-01-28WarningsExact identifier
application number: M032
QC Anti Dandruff T PlusCOAL TARGuangzhou Danting Bath&Body Care Industry Co. Ltd.2c7630ab-b7fa-462c-e063-6394a90a30bb2025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff 2 in 1PYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd2c762c86-ba7a-1976-e063-6394a90a49f22025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Dry Scalp CarePYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c764242-df65-7383-e063-6394a90a34b02025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Everyday CleanPYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c767d79-6ffe-ebaa-e063-6394a90a39d12025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Everyday CleanPYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd2c77edae-be2b-3a37-e063-6294a90a001d2025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Dry Scalp CarePYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd.2c77e4b6-5a65-c7ea-e063-6394a90a6abb2025-01-24WarningsExact identifier
application number: M032
Zincon Medicated Anti-DandruffPYRITHIONE ZINCNeoteric Cosmetics, Inc.2c26bd1e-35d4-f1a2-e063-6294a90af5762025-01-23WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSNa4fecf11-dd44-a06e-e053-2995a90afacf6
209884zinc pyrithione 10 MG/ML Medicated ShampooSCDa4fecf11-dd44-a06e-e053-2995a90afacf6
209884zinc pyrithione 1 % Medicated ConditionerSYa4fecf11-dd44-a06e-e053-2995a90afacf6
209884zinc pyrithione 1 % Medicated ShampooSYa4fecf11-dd44-a06e-e053-2995a90afacf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70533-003-027053300030259 mL in 1 TUBE (70533-003-02) 59 ml2020-10-010000-00-00NoNoCurrent
70533-003-1470533000314414 mL in 1 BOTTLE (70533-003-14) 414 ml2020-10-010000-00-00NoNoCurrent