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 17 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaZincPYRITHIONE ZINCWynnPharm Ince73010ae-291d-6adf-e053-2a95a90a8aea2025-11-14WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Advanced Series Pure Sport Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7bbd2559-4aba-9f18-e053-2991aa0a152e2025-11-13WarningsExact identifier
application number: M032
Divine Dandrene 1%ZINC PYRITHIONEDS Healthcare Group, Inc.ab605699-4090-45a3-882f-44379fe2a82e2025-11-11WarningsExact identifier
application number: M032
Divine Dandrene 2%ZINC PYRITHIONEDS Healthcare Group, Inc.54b0a610-dd15-4064-9feb-4d30b5e522ad2025-11-11WarningsExact identifier
application number: M032
Dandrene Anti-Dandruff ConditionerZINC PYRITHIONEDS Healthcare Group, Inc.aed49bfe-e016-46ac-a025-81b47cc081472025-11-11WarningsExact identifier
application number: M032
Minoxidil hair growth serumMINOXIDIL HAIR GROWTH SERUMJiashen International Trade Limited26cc22be-30f6-03da-e063-6394a90aafe72025-11-09WarningsExact identifier
application number: M032
Sulfur 8 Kids Anti-DandruffPYRITHIONE ZINCJ. Strickland & Co.89f4ecc8-7a49-42cb-b85d-71c9299e67122025-11-07WarningsExact identifier
application number: M032
Sulfur 8 Aqua BluePYRITHIONE ZINCJ. Strickland & Co.cdcf3cea-4a5d-4b8b-b47d-3163f9837d162025-11-07WarningsExact identifier
application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff ControlPYRITHIONE ZINCJ. Strickland and Co.96b26da0-d0d7-77ed-e053-2995a90a7a782025-11-07WarningsExact identifier
application number: M032
Shailee Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd02a71ce4-baf5-4231-afd6-21ef0b22e9312025-11-05WarningsExact identifier
application number: M032
Sulfur 8 Kids Anti-Dandruff Hair and Scalp ConditionerSULFURJ. Strickland & Co.8e9da3fd-701e-4354-bb00-ecd4dab48fa32025-11-03WarningsExact identifier
application number: M032
Denorex Severe Flakes Medicated Anti DandruffPYRITHIONE ZINCNeoteric Cosmetics, Inc.41ad0d3a-0704-44c9-e063-6394a90ad40d2025-10-21WarningsExact identifier
application number: M032
Stay Minoxidil Hair Regrowth TreatmentMINOXIDIL 5%HALORIA INC.41b745d7-6947-ec24-e063-6294a90aa4672025-10-21WarningsExact identifier
application number: M032
DERMOSCRIBE SEBORRHEIC DERMATITISSULFUR, SALICYLIC ACID, HYDROCORTISONEDERMOSCRIBE PTY LTD2b6bf90b-5d42-4c08-afee-56e13122285e2025-10-17WarningsExact identifier
application number: M032
Shea MoistureAPPLE CIDER VINEGAR INSTANT SCALP REFRESH ANTI-DANDRUFF SPRAYConopco, Inc. d/b/a Unilever414ab8ec-165c-21f8-e063-6294a90adc4f2025-10-16WarningsExact identifier
application number: M032
Shea MoistureAPPLE CIDER VINEGAR ANTI-DANDRUFF LEAVE-INConopco, Inc. d/b/a Unilever414b7fd2-6a65-af39-e063-6394a90a00b82025-10-16WarningsExact identifier
application number: M032
Seacall Natural Cedarwood OilNATURAL CEDARWOOD OILGuangdong Quadrant Ecological Technology Co., Ltd.1f4ebe4d-6e93-378c-e063-6394a90aec952025-10-15WarningsExact identifier
application number: M032
RemedyDandruffShampooTreatmentACTIIV REMEDY DANDRUFF SHAMPOO TREATMENTNaturich Cosmetique Labs129fd043-6643-cc46-e063-6294a90a6eae2025-10-08WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Cooling Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company40464e2d-f738-33ec-e063-6394a90a02c22025-10-03WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Clinical Strength Cooling Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company4046c345-e1ac-0ecc-e063-6294a90a59fa2025-10-03WarningsExact 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