Dandruff

Product NDC
41163-253
11-digit product format
411630253
Labeler code
41163
Product ID
41163-253_4b06137a-5bb6-557c-e063-6294a90a560b
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-21
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41163-25341163-253-15DDiscontinued by firm2026-10-15

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41163-25341163-253-15DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41163-25341163-253-15DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
77b2e0da-a6d7-42b5-92af-4e7979817b78Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-253-15Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO42017
41163-253-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO37017

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-253DANDRUFF (PYRITHIONE ZINC) SHAMPOO [UNITED NATURAL FOODS, INC. DBA UNFI]15Current NDC, Legacy NDC, 2 package rows20240915_77b2e0da-a6d7-42b5-92af-4e7979817b78.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 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
iBeaLee 5-in-1 5% Minoxidil Hair Regrowth SolutionMINOXIDILShenzhen Earth Surface Trading Co., Ltd.449fd486-69e2-2894-e063-6394a90a14212025-11-27WarningsExact identifier
application number: M032
DHS ZINCPYRITHIONE ZINCPerson and Covey39712814-4fe6-2a5b-e063-6294a90ab8cc2025-11-25WarningsExact identifier
application number: M032
Nioxin PRO CLINICAL SCALP RECOVERY purifyingPYRITHIONE ZINCWella Operations US LLC316c61e9-7cdf-a548-e063-6294a90ab7c32025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY moisturizing conditionerPYRITHIONE ZINCWella Operations US LLC31a715eb-7be8-8bad-e063-6394a90aba792025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serumPYRITHIONE ZINCThe Wella Corporation31ce9b5c-d388-8e1d-e063-6294a90a2fb82025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERYPYRITHIONE ZINCWella Operations US LLC31bf4f7f-8228-7433-e063-6394a90a2f5f2025-11-25WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCCARDINAL HEALTH 110, LLC. DBA LEADERd85f9017-6ab5-4ad6-a7f0-5570b20093cb2025-11-24WarningsExact identifier
application number: M032
Head and Shoulders Supreme Nourish and SmoothPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company8696c9d6-2306-4eb7-e053-2991aa0abd542025-11-24WarningsExact identifier
application number: M032
CeraVe Developed with Dermatologists Anti-Dandruff HydratingPYRITHIONE ZINCLOreal USA Products Inc0a64dfd9-13cc-4100-9c90-b006bac925052025-11-24WarningsExact identifier
application number: M032
FAMILY WELLNESS DRY SCALP 2 IN 1 DANDRUFF PLUS CONDITIONER Anti-DandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INC31891412-ac46-4497-a94b-558814f061fa2025-11-20WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Inc1a3bf938-fd9d-5544-e063-6294a90a9b642025-11-14WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Ince72e54ba-03fe-6748-e053-2a95a90a196f2025-11-14WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN77b2e0da-a6d7-42b5-92af-4e7979817b7817
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD77b2e0da-a6d7-42b5-92af-4e7979817b7817
209884zinc pyrithione 1 % Medicated ConditionerSY77b2e0da-a6d7-42b5-92af-4e7979817b7817
209884zinc pyrithione 1 % Medicated ShampooSY77b2e0da-a6d7-42b5-92af-4e7979817b7817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-253-1541163025315420 mL in 1 BOTTLE, PLASTIC (41163-253-15) 420 ml2015-01-210000-00-00NoNoCurrent
41163-253-3241163025332370 mL in 1 BOTTLE, PLASTIC (41163-253-32) 370 ml2023-11-01NoNoCurrent