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 5 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Recuren Plus Balanced ScalpSALICYLIC ACIDREGENEREN PLUS LTD50c27b0f-9bf5-de9c-e063-6394a90af41a2026-05-04WarningsExact identifier
application number: M032
Mielle Lavender and Lychee Scalp MoisturizingPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company510212e9-1d12-3a0a-e063-6294a90a1d782026-05-04WarningsExact identifier
application number: M032
Mielle Lavender and Lychee Scalp Soothing Daily RefresherPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company51033795-843b-844a-e063-6394a90ad0912026-05-04WarningsExact identifier
application number: M032
Mielle Lavender and Lychee Scalp Soothing ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5103ddfe-c5a1-3c4d-e063-6294a90aa4622026-05-04WarningsExact identifier
application number: M032
WalgreensSALICYLIC ACIDWalgreensec19b9b8-b97f-5277-e053-2a95a90a3c1e2026-05-03WarningsExact identifier
application number: M032
Pyrithione ZincCVSApollo Health and Beauty Care34047084-0b26-2385-e063-6394a90a204e2026-05-03WarningsExact identifier
application number: M032
CVS Itchy ScalpPYRITHIONE ZINCApollo Health and Beauty Care372b25d8-10b0-a049-e063-6394a90a4f612026-05-03WarningsExact identifier
application number: M032
CVS ANTI DANDRUFFPYRITHIONE ZINCApollo Health and Beauty Care3415172f-5a31-1085-e063-6394a90aabdc2026-05-03WarningsExact identifier
application number: M032
ProBliva Folliculitis .shampoo.SELENIUMDISULFIDE 1%CAVTECH HOLDING LLC502caa29-f817-cc12-e063-6394a90a22402026-04-23WarningsExact identifier
application number: M032
Dermoia DandruffPYRITHIONE ZINCTreasurewise LLC7884bd3e-62ab-4fcd-8870-0a941c3feadb2026-04-22WarningsExact identifier
application number: M032
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUMHAIR GROWTH SERUMPutian Licheng District Zhijiancheng Trading Co., Ltd.409de2af-f6f6-8181-e063-6294a90a0b4b2026-04-22WarningsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCAmazon.com Services LLC6a634331-eb08-4f18-8a57-692d089180822026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCBetter Living Brands, LLCeb1e3236-5981-46c3-ae06-bed61f02a3282026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCTarget Corporationcc3df9d0-0c16-4176-99d7-d0aec2366f2c2026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCTarget Corporationa9d92e08-a77f-45dd-b95a-9923202df40b2026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
DovePYRITHIONE ZINCConopco, Inc. d/b/a/ Unilever7885a86b-f1a4-f2cc-e053-2991aa0ab6772026-04-20WarningsExact identifier
application number: M032
BalancingZINC PYRITHIONEZero Flakes Given, Inc.984780fd-4969-150b-e053-2995a90aed772026-04-16WarningsExact identifier
application number: M032
RestoringPYRITHIONE ZINCZero Flakes Given, Inc.4f9934e4-ec37-9f68-e063-6394a90ab9a42026-04-16WarningsExact identifier
application number: M032
BalancingPYRITHIONE ZINCZero Flakes Given, Inc.4f9a51ba-aea6-081f-e063-6394a90a41222026-04-16WarningsExact identifier
application number: M032
Dove Men CareANTI-DANDRUFF GENTLE CLEAN 2 IN 1 SHAMPOO AND CONDITIONERConopco d/b/a Unilever4ef4b64f-e75d-a2ae-e063-6394a90abd802026-04-08WarningsExact 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