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 7 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Smooth and Silky KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4d38902f-a6ae-620f-e063-6394a90ae9322026-03-17WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Shampoo.SALICYLIC ACID 3%RoyceDerm LLC4d2f6e29-5d75-6982-e063-6294a90ada8d2026-03-16WarningsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCCVS Pharmacy, Inc.f286a5fd-7916-49bc-97a1-ad737ac5b14a2026-03-13Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders Itchy ScalpPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company54df1acc-4265-494c-879e-c690184d7ae22026-03-13WarningsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCH E Ba58b9119-2adb-459f-86f4-95df28a430c52026-03-13Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCBetter Living Brands, LLCf90d1fb2-4bd7-4d70-81b4-4541f4e3a3d62026-03-13Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders Smooth and Silky ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4cec08cb-aba5-41ce-e063-6294a90adfdf2026-03-13WarningsExact identifier
application number: M032
OLIVITA MinoxidilMINOXIDILShenzhen Xinxin Yunhai Technology Co., Ltd.4cf37b0b-bbb8-1d9c-e063-6294a90af8182026-03-13WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCNice-Pak Products, LLC3c55b70f-7627-8667-e063-6394a90a5cf82026-03-12Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders 2in1 Classic CleanPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company65a4082f-227b-49bf-b88c-b1c651ed13a02026-03-12WarningsExact identifier
application number: M032
Head and Shoulders Green Apple 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc036c9a6-6507-4037-b97b-1b015dd950c12026-03-12WarningsExact identifier
application number: M032
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.4ca9a661-fa39-ab7f-e063-6294a90aed142026-03-10WarningsExact identifier
application number: M032
iBeaLee 5% Minoxidil Hair Regrowth Treatment5% MINOXIDILShenzhen Earth Surface Trading Co., Ltd.4cb728d0-6abe-6645-e063-6394a90acb4c2026-03-10WarningsExact identifier
application number: M032
DHS TarCOAL TARPerson and Covey4c5f7278-c53a-cef6-e063-6394a90a00082026-03-09WarningsExact identifier
application number: M032
DHS ZINCPYRITHIONE ZINCPerson and Covey4c98c0af-c3d0-211e-e063-6294a90a8e122026-03-09WarningsExact identifier
application number: M032
DHS SALSALICYLIC ACIDPerson and Covey4c9b75b5-9c7d-c4a8-e063-6394a90a4a6b2026-03-09WarningsExact identifier
application number: M032
DHS BODY WASHZINC PYRITHIONE WASHPerson and Covey4c9d5b33-9a1e-9db1-e063-6294a90adbae2026-03-09WarningsExact identifier
application number: M032
BiotinBIOTINShenzhen yuehaotong Technology Co.,Ltd4c6ec616-a84e-6e1a-e063-6294a90a2aae2026-03-07WarningsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCOld East Main Co.5368b466-a804-471c-8287-0dd120c0d5092026-03-03Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCAmazon.com Services LLCc187bb79-8190-4a3d-a966-af74198ee5462026-03-03Warnings, Adverse reactionsExact 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