FDA.reportPublic FDA data

Dandruff

Product NDC
41163-024
11-digit product format
411630024
Labeler code
41163
Product ID
41163-024_4b06c184-4d5b-4838-e063-6294a90a8176
Type
HUMAN OTC DRUG
Nonproprietary name
PYRITHIONE ZINC
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-10-26
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41163-02441163-024-15DDiscontinued by firm2026-10-05
excluded packagepackage41163-02441163-024-35DDiscontinued 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 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41163-024-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41163-024-35d630ba8d3edf…732f749b63fb…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41163-024-35557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41163-024-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41163-024-15557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41163-024-32557ba5c1ecfa…9c80585c8c6e…

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
Dandruff
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
d7c4507e-7f74-4bcd-9b0e-0b097193a1a8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-024-15Dandruff420 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO42016
41163-024-32Dandruff370 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO37016
41163-024-35Dandruff700 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO70016
41163-024-40Dandruff612 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO61216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
AMODIMETHICONE (800 CST)INACTIVE INGREDIENT363Z2T48P7DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21WDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)INACTIVE INGREDIENTB16G315W7ADANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
MAGNESIUM CARBONATE HYDROXIDEINACTIVE INGREDIENTYQO029V1L4DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFADANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950URDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1
ZINC CARBONATEINACTIVE INGREDIENTEQR32Y7H0MDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-024DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [UNITED NATURAL FOODS, INC. DBA UNFI]14Current NDC, Legacy NDC, 4 package rows20250429_d7c4507e-7f74-4bcd-9b0e-0b097193a1a8.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 16 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PS-2896 Hydrocortisone Cream 1%, 0.9gPS-2896 HYDROCORTISONE CREAM 1%, 0.9GProStat First Aid LLC0074e7bf-8c62-a5a7-e063-6394a90a63fc2025-12-15WarningsExact identifier
application number: M032
Hydrocortisone 1%HYDROCORTISONE 1%ProStat First Aid LLCf707bda4-074a-6406-e053-6394a90a7ae12025-12-15WarningsExact identifier
application number: M032
Hydrocortisone Cream 1%HYDROCORTISONE CREAM 1%Front Line Safety0f4ede34-7e70-789e-e063-6394a90a72a42025-12-15WarningsExact identifier
application number: M032
Head and Shoulders Deep Moisture Hair and Scalp ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company58ecdd38-1f23-ee32-e053-2991aa0afe812025-12-15WarningsExact identifier
application number: M032
Head and Shoulders Deep MoisturePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5e2133c2-032d-4c16-e053-2991aa0ac61b2025-12-15WarningsExact identifier
application number: M032
Dermgentle Seborrheic Face CreamPYRITHIONE ZINCDermgentle LLC45232668-6953-80a0-e063-6294a90a6e4b2025-12-12WarningsExact identifier
application number: M032
Kadason MedicatedSALICYLIC ACIDYs Pharma Inc.f425408c-95b1-409f-b64f-2e9f2f3310a02025-12-10WarningsExact identifier
application number: M032
Zinc PyrithioneZINC PYRITHIONEHarry's Inc.a6fdb13b-7943-3ae9-e053-2995a90a9db52025-12-08WarningsExact identifier
application number: M032
Walgreens Dandruff Conditioner 2 in 1 Itchy Scalp Anti-dandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INCbf7b2339-20a4-4bab-b82f-6e28ff5187cb2025-12-08WarningsExact identifier
application number: M032
therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARGOODSENSE72ab0e6b-72a5-4e8a-af44-963251b0641f2025-12-08WarningsExact identifier
application number: M032
Equate Mens Bold Scent 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INC5ccd409b-a81f-41bc-b986-bc7c0cc643fd2025-12-08WarningsExact identifier
application number: M032
Gold Bond Psoriasis Relief Medicated Multi-SymptomSALICYLIC ACIDGold Bond Co LLC5949a2e4-9169-4fca-aabb-b18dd1bc298b2025-12-04WarningsExact identifier
application number: M032
Medicasp Anti-DandruffCOAL TARGenomma Lab USA07bc9cab-4215-4bc0-9104-e6cf85d74b682025-12-04WarningsExact identifier
application number: M032
Dermaharmony Sulfur and Salicylic AcidSALICYLIC ACID, SULFURD3 Development, Inc.8cb1d526-1ba7-6b02-e053-2a95a90aa1d02025-12-02WarningsExact identifier
application number: M032
Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.6b2de5ba-ad4b-5d43-e053-2991aa0ac3b22025-12-02WarningsExact identifier
application number: M032
Dermaharmony 1% Pyrithione ZincPYRITHIONE ZINCD3 Development, Inc.b9e765eb-f55f-f38a-e053-2a95a90aafd12025-12-02WarningsExact identifier
application number: M032
CeraVe 2 in1 Anti Dandruff Hydrating ConditionerPYRITHIONE ZINCL'Oreal USA Products Inc8a7b4626-d76b-45c4-b7a3-33c91e9a0bfe2025-12-02WarningsExact identifier
application number: M032
Head and Shoulders Apple Cider VinegarPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyb6984dab-e3da-3f36-e053-2995a90a2c0e2025-12-01WarningsExact identifier
application number: M032
DHS TARCOAL TARPerson and Covey4d088ad5-1f89-48fe-ac8a-12cb62847b382025-11-28WarningsExact identifier
application number: M032
DHS SAL 4 oz.DHS SALPerson and Covey62e13b0d-2455-46c2-bff3-1aa88b0923272025-11-28WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSNd7c4507e-7f74-4bcd-9b0e-0b097193a1a816
209884zinc pyrithione 10 MG/ML Medicated ShampooSCDd7c4507e-7f74-4bcd-9b0e-0b097193a1a816
209884zinc pyrithione 1 % Medicated ConditionerSYd7c4507e-7f74-4bcd-9b0e-0b097193a1a816
209884zinc pyrithione 1 % Medicated ShampooSYd7c4507e-7f74-4bcd-9b0e-0b097193a1a816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-024-1541163002415420 mL in 1 BOTTLE, PLASTIC (41163-024-15) 420 ml2006-10-260000-00-00NoNoCurrent
41163-024-3241163002432370 mL in 1 BOTTLE, PLASTIC (41163-024-32) 370 ml2023-11-02NoNoCurrent
41163-024-3541163002435700 mL in 1 BOTTLE, PLASTIC (41163-024-35) 700 ml2006-10-260000-00-00NoNoCurrent
41163-024-4041163002440612 mL in 1 BOTTLE, PLASTIC (41163-024-40) 612 ml2023-11-02NoNoCurrent