FDA.reportPublic FDA data

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
70533-003-022024-12-17Anti-dandruff
70533-003-142024-12-17Anti-dandruff
70533-003-022024-07-30Anti-dandruff
70533-003-142024-07-30Anti-dandruff
70533-003-022024-01-30Anti-dandruff
70533-003-142024-01-30Anti-dandruff
70533-003-022021-08-27Anti-dandruff
70533-003-142021-08-27Anti-dandruff
70533-003-022021-07-23Anti-dandruff
70533-003-142021-07-23Anti-dandruff

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 6 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoveSOOTHING MOISTURE DAMAGE THERAPY ANTI-DANDRUFF CONDITIONERConopco d/b/a Unilever4ef55722-df78-0e4c-e063-6294a90a85402026-04-08WarningsExact identifier
application number: M032
Dove Men CareFORTIFYING SHAMPOO AND CONDITIONER ANTI-DANDRUFF 2 IN 1 PYRITHIONE ZINC SHAMPOOConopco d/b/a Unilever4ecf22e8-e318-26f7-e063-6294a90a54772026-04-07WarningsExact identifier
application number: M032
Dove Men CareANTI-DANDRUFF 2IN1 SHAMPOO AND CONDITIONERConopco d/b/a Unilever4ecce67b-b2e0-b757-e063-6294a90a224e2026-04-07WarningsExact identifier
application number: M032
Dove Men CareANTI-DANDRUFF DRYNESS AND ITCH RELIEF 2 IN 1 SHAMPOO AND CONDITONERConopco d/b/a Unilever4edfa86c-0139-5bc5-e063-6294a90a5d732026-04-07WarningsExact identifier
application number: M032
DoveSOOTHING MOISTURE DAMAGE THERAPY ANTI-DANDRUFF SHAMPOOConopco d/b/a Unilever4ecb2eac-0d1c-b59d-e063-6394a90a49e32026-04-06WarningsExact identifier
application number: M032
Happy Head Anti-DandruffPYRITHIONE ZINCHappy Head, Incf0d5daea-72fc-4e40-a390-9da42cadbe3a2026-04-06WarningsExact identifier
application number: M032
DoveCALMING RELIEF DAMAGE THERAPY ANTI-DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONERConopco d/b/a Unilever4ecc1232-065f-c63e-e063-6394a90ac63b2026-04-06WarningsExact identifier
application number: M032
Suave Professionals Men 2 in 1 Classic Clean AntiDandruffPYRITHIONE ZINCConopco Inc. d/b/a Unileverd85e52e5-c3e2-4be0-aa3f-3511a69ecc4f2026-04-03WarningsExact identifier
application number: M032
Denorex Multi-Symptom Anti-DandruffSALICYLIC ACIDNeoteric Cosmetics, Inc.4e904a6b-a732-558b-e063-6294a90ac6422026-04-01WarningsExact identifier
application number: M032
Denorex Extra StrengthSALICYLIC ACIDNeoteric Cosmetics, Inc.21d234ff-f379-4bcd-9ba0-90f27c6d3a692026-04-01WarningsExact identifier
application number: M032
EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00Qingyuan Moksha Biotechnology Co., Ltd.4e386cc8-004a-9742-e063-6394a90a763c2026-03-30WarningsExact identifier
application number: M032
Tio Nacho Anti-DandruffSALICYLIC ACIDGenomma Lab USAc3c92b35-4955-4985-9a1d-8756c1b2131c2026-03-27WarningsExact identifier
application number: M032
Suave Antidandruff 2 IN 1 Classic CleanANTI DANDRUFF 2N1 SHAMPOO AND CONDITIONERSuave Brands Co., LLC41d9cfec-6d14-f620-e063-6294a90a078d2026-03-26WarningsExact identifier
application number: M032
Suave Anti dandruff Coconut MoistureANTI DANDRUFF SHAMPOOSuave Brands Co., LLC41da3d90-4845-0d8f-e063-6294a90aede12026-03-26WarningsExact identifier
application number: M032
Suave Men 2 IN1 Scalp DefenseANTI DANDRUFF SHAMPOO AND CONDITIONERSuave Brands Co., LLC42517082-4d0a-90a3-e063-6294a90a59272026-03-26WarningsExact identifier
application number: M032
Suave Men Antidandruff 2 IN 1 Classic CleanANTI DANDRUFF SHAMPOO AND CONDITIONERSuave Brands Co., LLC425264b9-62a9-fd7b-e063-6294a90a37a22026-03-26WarningsExact identifier
application number: M032
Pyrithione ZincPYRITHIONE ZINCNice-Pak Products, LLC4db2aaf4-5caf-d9e5-e063-6294a90aa4ea2026-03-23Warnings, Adverse reactionsExact identifier
application number: M032
MG217 Psoriasis Medicated multi-symptomCOAL TARWisconsin Pharmacal Company7cb04d20-9b3c-27bb-e053-2a91aa0a5bc42026-03-20WarningsExact identifier
application number: M032
MG217 Psoriasis Therapeutic ConditionerSALICYLIC ACIDWisconsin Pharmacal Company246f239f-16fb-24b2-e054-00144ff8d46c2026-03-20WarningsExact identifier
application number: M032
Dermeleve Scalp Psoriasis TreatmentSALICYLIC ACIDAdvanced Derm Solutions LLCf55da7a8-0a26-4925-bd3b-fade6156116d2026-03-19WarningsExact 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