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 20 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Structure of Skin Soothing Anti-DandruffPYRITHIONE ZINCSTRUCTURE OF SKIN LLC3311fa83-a06b-b379-e063-6394a90ae2692025-04-18WarningsExact identifier
application number: M032
LILIVERA Hair Regrowth KitMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.330602da-ec17-5a35-e063-6394a90a741b2025-04-17WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company3272a482-3813-63e4-e063-6394a90a43eb2025-04-10WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse for normal hairPYRITHIONE ZINCRejoice International Inc.b90e574c-933c-4f86-aadc-567ffbe6ea042025-04-09WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse for sensitive hairPYRITHIONE ZINCRejoice International Inc.979394c2-5681-44c8-a43c-bf3a392bd0c12025-04-09WarningsExact identifier
application number: M032
LEAHUE MADHUCA TONICSALICYLIC ACIDBio-interchange Co.31ee4645-0f64-f7a0-e063-6394a90a17362025-04-04WarningsExact identifier
application number: M032
LEAHUE MADHUCASALICYLIC ACIDBio-interchange Co.81470dfe-f063-9d16-e053-2a91aa0a18292025-04-04WarningsExact identifier
application number: M032
Kenkoderm Psoriasis MoisturizingSALICYLIC ACIDNexgel,Inc.31ce20a2-95ae-e424-e063-6394a90af18a2025-04-01WarningsExact identifier
application number: M032
Kenkoderm PsoriasisSALICYLIC ACIDNexgel,Inc.31cf90e5-0f21-903d-e063-6394a90a075d2025-04-01WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serumPYRITHIONE ZINCThe Wella Corporation31af9365-e1a3-7203-e063-6294a90a8ade2025-03-31WarningsExact identifier
application number: M032
Listarfe Anti-Dandruff Shampoo.ANTI-DANDRUFF SHAMPOOGuangzhou Zanming Trading Co., Ltd.3163eee0-379f-1f88-e063-6294a90a58ce2025-03-28WarningsExact identifier
application number: M032
anti dandruff SHAMPOOSPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD31392f0f-a6c4-1cfb-e063-6294a90a4d362025-03-26WarningsExact identifier
application number: M032
anti dandruff SHAMPOOSPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD313716f7-6dd2-e1c5-e063-6394a90a9de32025-03-25WarningsExact identifier
application number: M032
CeraVe Anti Dandruff HydratingPYRITHIONE ZINCL'Oreal USA Products Inc422e743b-fd77-40ed-8c5d-7f05112a447f2025-03-24WarningsExact identifier
application number: M032
Scalp RevivalSALICYLIC ACID 3%Beccair, LLC0a77e90e-a33a-43f3-80a0-a16a6902a7352025-03-21WarningsExact identifier
application number: M032
Gold Bond Psoriasis Relief Medicated Multi-SymptomSALICYLIC ACIDChattem, Inc.e8479bbc-5f49-41f2-851e-a935435166392025-03-19WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINCRejoice International Corp.308554c2-938b-f0b5-e063-6394a90a5bfa2025-03-17WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINCRejoice International Corp.3086d31e-54ef-9c0f-e063-6394a90abdff2025-03-17WarningsExact identifier
application number: M032
SA Scalp TherapySA SCALPMilbar Laboratories304db1ab-acd7-43d5-e063-6294a90aeec22025-03-14WarningsExact identifier
application number: M032
Neutrogena Scalp Therapy Anti-Dandruff Itchy ScalpSALICYLIC ACIDKenvue Brands LLCca4c0d63-50b3-169f-e053-2a95a90acbcd2025-03-10WarningsExact 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