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 firm2026-10-05
excluded packagepackage70533-00370533-003-02DDiscontinued by firm2026-10-05
excluded packagepackage70533-00370533-003-14DDiscontinued by firm2026-10-05

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 16 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicasp Anti-DandruffCOAL TARGenomma Lab USA07bc9cab-4215-4bc0-9104-e6cf85d74b682025-12-04WarningsExact identifier
application number: M032
Dermaharmony Sulfur and Salicylic AcidSALICYLIC ACID, SULFURD3 Development, Inc.8cb1d526-1ba7-6b02-e053-2a95a90aa1d02025-12-02WarningsExact identifier
application number: M032
Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.6b2de5ba-ad4b-5d43-e053-2991aa0ac3b22025-12-02WarningsExact identifier
application number: M032
Dermaharmony 1% Pyrithione ZincPYRITHIONE ZINCD3 Development, Inc.b9e765eb-f55f-f38a-e053-2a95a90aafd12025-12-02WarningsExact identifier
application number: M032
CeraVe 2 in1 Anti Dandruff Hydrating ConditionerPYRITHIONE ZINCL'Oreal USA Products Inc8a7b4626-d76b-45c4-b7a3-33c91e9a0bfe2025-12-02WarningsExact identifier
application number: M032
Head and Shoulders Apple Cider VinegarPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyb6984dab-e3da-3f36-e053-2995a90a2c0e2025-12-01WarningsExact identifier
application number: M032
DHS TARCOAL TARPerson and Covey4d088ad5-1f89-48fe-ac8a-12cb62847b382025-11-28WarningsExact identifier
application number: M032
DHS SAL 4 oz.DHS SALPerson and Covey62e13b0d-2455-46c2-bff3-1aa88b0923272025-11-28WarningsExact identifier
application number: M032
iBeaLee 5-in-1 5% Minoxidil Hair Regrowth SolutionMINOXIDILShenzhen Earth Surface Trading Co., Ltd.449fd486-69e2-2894-e063-6394a90a14212025-11-27WarningsExact identifier
application number: M032
DHS ZINCPYRITHIONE ZINCPerson and Covey39712814-4fe6-2a5b-e063-6294a90ab8cc2025-11-25WarningsExact identifier
application number: M032
Nioxin PRO CLINICAL SCALP RECOVERY purifyingPYRITHIONE ZINCWella Operations US LLC316c61e9-7cdf-a548-e063-6294a90ab7c32025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY moisturizing conditionerPYRITHIONE ZINCWella Operations US LLC31a715eb-7be8-8bad-e063-6394a90aba792025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serumPYRITHIONE ZINCThe Wella Corporation31ce9b5c-d388-8e1d-e063-6294a90a2fb82025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERYPYRITHIONE ZINCWella Operations US LLC31bf4f7f-8228-7433-e063-6394a90a2f5f2025-11-25WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCCARDINAL HEALTH 110, LLC. DBA LEADERd85f9017-6ab5-4ad6-a7f0-5570b20093cb2025-11-24WarningsExact identifier
application number: M032
Head and Shoulders Supreme Nourish and SmoothPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company8696c9d6-2306-4eb7-e053-2991aa0abd542025-11-24WarningsExact identifier
application number: M032
CeraVe Developed with Dermatologists Anti-Dandruff HydratingPYRITHIONE ZINCLOreal USA Products Inc0a64dfd9-13cc-4100-9c90-b006bac925052025-11-24WarningsExact identifier
application number: M032
FAMILY WELLNESS DRY SCALP 2 IN 1 DANDRUFF PLUS CONDITIONER Anti-DandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INC31891412-ac46-4497-a94b-558814f061fa2025-11-20WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Inc1a3bf938-fd9d-5544-e063-6294a90a9b642025-11-14WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Ince72e54ba-03fe-6748-e053-2a95a90a196f2025-11-14WarningsExact 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