Pyrithione zinc

Product NDC
76162-970
11-digit product format
761620970
Labeler code
76162
Product ID
76162-970_4ab95f11-c8a5-04b5-e063-6294a90a79d9
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-25
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Pyrithione zinc
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC10 mg/mL

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
2c1420a8-404f-4fd7-8f07-cd441b390ac2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-970-32Pyrithione zinc370 mL in 1 BOTTLE, PLASTICSHAMPOO3704

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-970PYRITHIONE ZINC SHAMPOO [TOPCO ASSOCIATES LLC]2Current NDC, 1 package rows20241027_2c1420a8-404f-4fd7-8f07-cd441b390ac2.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 ShampooPSN2c1420a8-404f-4fd7-8f07-cd441b390ac24
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD2c1420a8-404f-4fd7-8f07-cd441b390ac24
209884zinc pyrithione 1 % Medicated ConditionerSY2c1420a8-404f-4fd7-8f07-cd441b390ac24
209884zinc pyrithione 1 % Medicated ShampooSY2c1420a8-404f-4fd7-8f07-cd441b390ac24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-970-3276162097032370 mL in 1 BOTTLE, PLASTIC (76162-970-32) 370 ml2024-10-25NoNoCurrent