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 30 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Therapeutic Dandruff Original Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.78cabb38-9f9d-403d-b79c-ceedcea1812f2023-11-20WarningsExact identifier
application number: M032
Aloe Coal 01PYRITHIONE ZINCT. SPRUILL, LLC40a94657-6722-46b1-87ed-a15bf60ffc7a2023-11-11WarningsExact identifier
application number: M032
HAIRCARE Physicians RecommendedSALICYLIC ACIDLAWRENCE E SAMUELS MD INC095fcc1c-8f5b-47bd-a32a-7f5da5d162cd2023-11-11WarningsExact identifier
application number: M032
Home Health Psoriasis Medicated Scalp and Body WashSALICYLIC ACIDHome Healthd10dad0e-34e1-49d4-a17a-36dbdbd66eb62023-11-06WarningsExact identifier
application number: M032
Glovers Therapeutic CareSALICYLIC ACIDJ. Strickland and Co.bf101147-1408-4819-829a-6079f64483002023-11-05WarningsExact identifier
application number: M032
Sulfur 8 Medicated Dandruff with Salicylic AcidSALICYLIC ACIDJ. Strickland and Co.14f41263-9999-448d-a479-abf67fb3b27b2023-11-05WarningsExact identifier
application number: M032
Home Health Everclean AntidandruffSALICYLIC ACIDHome Health851ef329-f9be-4d50-87aa-b6c5eb3a2a892023-11-05WarningsExact identifier
application number: M032
Doo Gro Anti-Dandruff VitalizerSALICYLIC ACIDJ. Strickland & Co. DBA Nature's Protein, Inc.ad05695d-371d-4c38-8f78-b6736b505ab72023-10-31WarningsExact identifier
application number: M032
Doo Gro Anti-Dandruff VitalizerPYRITHIONE ZINCJ. Strickland & Co. DBA Nature's Protein, Inc.7366c6f8-4cc2-520e-e053-2991aa0a2cc82023-10-31WarningsExact identifier
application number: M032
Compound W Total Care Wart and Skin KitSALICYLIC ACIDHK Kolmar Canada, Incdef46762-990a-48b0-b702-15ece1dc541f2023-10-27WarningsExact identifier
application number: M032
Satinique Anti DandruffPYRITHIONE ZINCAccess Business Group LLCae71967e-110d-4fae-a966-8382ca62bc1f2023-10-23WarningsExact identifier
application number: M032
Glovers Anti-DandruffSULFUR, SALICYLIC ACIDJ. Strickland & Co.49fd4e03-736c-429a-8972-7302b732f8162023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Oil Moisturizer Anti-DandruffPYRITHIONE ZINCJ. Strickland & Co.abb85f88-78bb-4d84-9436-4616b31c63d12023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Anti-Dandruff BraidSALICYLIC ACIDJ. Strickland & Co.d240be47-8b86-4836-8407-c9ffe44628e82023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Light Moisturizer Anti-DandruffPYRITHIONE ZINCJ. Strickland & Co.8af5f208-f132-4e09-b353-ef12633ad3502023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Fresh Anti-Dandruff MoisturizingPYRITHIONE ZINCJ. Strickland & Co.93c7c97b-7cd2-4d70-b437-6c175c8bab902023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Fresh Anti-DandruffSALICYLIC ACIDJ. Strickland & Co.5acd1aab-3a6d-4d2c-8c80-271ab8dcac1a2023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Five Star Anti-Dandruff Hair GroomPYRITHIONE ZINCJ. Strickland & Co.bff46093-8186-4b2e-9363-03e67d04227a2023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Fresh Anti-Dandruff Oil MoisturizingPYRITHIONE ZINCJ. Strickland & Co.9f1886c7-5a19-4706-83dc-828d7ed06b192023-10-21WarningsExact identifier
application number: M032
Glovers Dandruff Control Med., FloralSULFURJ. Strickland & Co.a1224e4a-e811-4415-a038-3933da43d8192023-10-21WarningsExact 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