Zinc Pyrithione

Product NDC
70533-004
11-digit product format
705330004
Labeler code
70533
Product ID
70533-004_4578b224-267f-52f3-e063-6294a90a9522
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Pyrithione
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Harry's Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-01
Substance
PYRITHIONE ZINC
Active strength
20 mg/2mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage70533-004-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70533-004-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70533-004-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70533-004-14367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Zinc Pyrithione
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC20 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R953O2RHZ5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209884Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6fdb13b-7943-3ae9-e053-2995a90a9db5Available on FDA.report

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
70533-004-02Zinc Pyrithione59 mL in 1 TUBESHAMPOO598
70533-004-14Zinc Pyrithione414 mL in 1 BOTTLESHAMPOO4148

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70533-004ZINC PYRITHIONE SHAMPOO [HARRY'S INC.]7Current NDC, Legacy NDC, 2 package rows20250117_a6fdb13b-7943-3ae9-e053-2995a90a9db5.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 22 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Dandruff 2 in 1PYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c6289a3-2f09-c094-e063-6394a90a81f92025-01-23WarningsExact identifier
application number: M032
Tuymec Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOGuangzhou Zanming Trading Co., Ltd.2c62d04e-dcb6-a33e-e063-6394a90a2e8e2025-01-23WarningsExact identifier
application number: M032
QC Anti Dandruff T PlusCOAL TARChain Drug Marketing Association, Inc.2bea5414-c7bc-d010-e063-6294a90aa1382025-01-17WarningsExact identifier
application number: M032
Meijer Medicated Selenium Sulfide Anti-DandruffSELENIUM SULFIDEMeijer Distribution, Inc41b563c6-5df6-4ead-bddf-a69a07970ea02025-01-14WarningsExact identifier
application number: M032
D-COL Personal Hygiene Convenience kitPYRITHIONE ZINC AND CHLOROXYLENOLD-COL Inc273fcc6f-9c54-42b0-aa0c-9051457b13412025-01-14WarningsExact identifier
application number: M032
Equate Mens Ultra Sport 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.f8767db7-e208-4ccc-85f7-789e281c7f262025-01-10WarningsExact identifier
application number: M032
Equate Soft and Smooth 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.c759b347-bdfb-4ff5-a464-b40fa2efb8432025-01-10WarningsExact identifier
application number: M032
Equate Mens Bold Scent 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.d561e8d2-2761-422b-8f05-ac76d3a043eb2025-01-10WarningsExact identifier
application number: M032
Royal Oils by Head and Shoulders Sulfate Free Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyd73ab807-027f-7581-e053-2995a90ada832025-01-08WarningsExact identifier
application number: M032
Head and Shoulders Supreme Color Protect ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86ac3037-9ff2-25ea-e053-2a91aa0a43e32025-01-08WarningsExact identifier
application number: M032
Oribe Serene Scalp Anti DandruffORIBE SERENE SCALP ANTI DANDRUFFOribe Hair Care LLCe5702ac7-e680-ab4b-e053-2995a90ad4422025-01-01WarningsExact identifier
application number: M032
Oribe Serene Scalp Anti DandruffORIBE SERENE SCALP ANTI DANDRUFFOribe Hair Care LLCabaf1c64-1c4d-481a-9872-b64fcf82cc632025-01-01WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp CareSALICYLIC ACIDTAI GUK PHARM. CO., LTDe8bdad4d-d499-70a9-e053-2a95a90a5cd92025-01-01WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1SALICYLIC ACIDTAI GUK PHARM. CO., LTDe8bf3852-e963-7a48-e053-2995a90a5aa12025-01-01WarningsExact identifier
application number: M032
American CrewPYRITHIONE ZINCRevlon Consumer Products Corp9566b567-90be-4803-b940-e6a91750778f2024-12-30WarningsExact identifier
application number: M032
Kerastase Paris K Symbiose Serum Nuit Antipelliculaire Intensif Antidandruff TreatmentSALICYLIC ACIDL'Oreal USA Products Inc.d72688ed-d153-4eed-988f-5386eb68559d2024-12-30WarningsExact identifier
application number: M032
Dermaharmony Seborrheic DermatitisPYRITHIONE ZINCD3 Development, Inc.8d81521d-9e6f-1acf-e053-2995a90a92422024-12-20WarningsExact identifier
application number: M032
Dermaharmony Sulfur and Salicylic AcidSALICYLIC ACID, SULFURD3 Development, Inc.a1c61da2-7e7a-430a-e053-2995a90ad5942024-12-20WarningsExact identifier
application number: M032
Dermaharmony Bar PeppermintSALICYLIC ACID, SULFURD3 Development, Inc.af7060a9-986c-500e-e053-2a95a90a64382024-12-20WarningsExact identifier
application number: M032
Dermaharmony Bar PeppermintPYRITHIONE ZINCD3 Development, Inc.a19b74b0-88c6-6897-e053-2a95a90a73092024-12-20WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSNa6fdb13b-7943-3ae9-e053-2995a90a9db58
209884zinc pyrithione 10 MG/ML Medicated ShampooSCDa6fdb13b-7943-3ae9-e053-2995a90a9db58
209884zinc pyrithione 1 % Medicated ConditionerSYa6fdb13b-7943-3ae9-e053-2995a90a9db58
209884zinc pyrithione 1 % Medicated ShampooSYa6fdb13b-7943-3ae9-e053-2995a90a9db58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70533-004-027053300040259 mL in 1 TUBE (70533-004-02) 59 ml2020-10-010000-00-00NoNoCurrent
70533-004-1470533000414414 mL in 1 BOTTLE (70533-004-14) 414 ml2020-10-010000-00-00NoNoCurrent