FDA.reportPublic FDA data

Dandruff

Product NDC
41163-153
11-digit product format
411630153
Labeler code
41163
Product ID
41163-153_4af72577-4c37-3fb0-e063-6394a90a214b
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
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 packagepackage41163-15341163-153-15DDiscontinued by firm2026-10-15
excluded packagepackage41163-15341163-153-35DDiscontinued by firm2026-10-15

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
66f301bf-8e2e-43ce-b6b8-0983fe795f01Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-153-15Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO42017
41163-153-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO37017
41163-153-35Dandruff700 mL in 1 BOTTLE, PLASTICSHAMPOO70017
41163-153-40Dandruff612 mL in 1 BOTTLE, PLASTICSHAMPOO61217

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
41163-153DANDRUFF (PYRITHIONE ZINC) SHAMPOO [UNITED NATURAL FOODS, INC. DBA UNFI]15Current NDC, Legacy NDC, 4 package rows20250429_66f301bf-8e2e-43ce-b6b8-0983fe795f01.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 19 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMBANNER Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.383926b7-997b-af1e-e063-6394a90a506d2025-06-23WarningsExact identifier
application number: M032
Brickell Mens Products Relieving Anti-DandruffSALICYLIC ACIDBRICKELL BRANDS LLC7ba3b13b-cb78-4df8-8719-c88e556643b42025-06-16WarningsExact identifier
application number: M032
VENROCKPIROCTONE OLAMINE AND SALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.372feca7-f6f1-cd38-e063-6294a90a3bfe2025-06-12WarningsExact identifier
application number: M032
Neutrogena T/Sal TherapeuticSALICYLIC ACIDKenvue Brands LLC54707f0f-6025-4dc3-8be8-7a38bb1363b82025-06-05WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SAaae04d08-9d0c-43bd-89c2-741884de3bea2025-06-04WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDL'Oreal USA Products Incbcffd505-82bd-45ce-9ad0-64a9e63f62b52025-06-04WarningsExact identifier
application number: M032
UCHOIZE S2 Balance Anti-DandruffUCHOIZE S2 BALANCE ANTI-DANDRUFF SHAMPOODreamwise International Corp36a5efa8-0617-868d-e063-6394a90a17052025-06-03WarningsExact identifier
application number: M032
DermaD ATOPIC DERMATITIS TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.d872a4ee-554e-4bca-acb1-3bbf57dc690b2025-05-29WarningsExact identifier
application number: M032
DermaD JOCK ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.c8c0449c-11f9-4434-a91c-b690d67808202025-05-29WarningsExact identifier
application number: M032
DermaD Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.e52c647b-8cdc-4023-af22-fbfb84ea0ada2025-05-27WarningsExact identifier
application number: M032
DermaER Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.f62e6c5e-6e80-4b75-a0b1-c893224d9ce42025-05-27WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Ince71e87ba-2a62-44f3-e053-2995a90a8b112025-05-25WarningsExact identifier
application number: M032
Tagrid ANTI FUNGALZINC PYRITHIONE,SALICYLIC ACIDTAGRID LLC3376b104-1f07-fab3-e063-6394a90a0ca42025-05-22WarningsExact identifier
application number: M032
Coal TarCOAL TARNopsor USA Distribution Co., Inc.407bd007-bec6-2864-e054-00144ff88e882025-05-05WarningsExact identifier
application number: M032
AntiDandruffShampoo365 ANTI DANDRUFF SHAMPOOWhole Foods Market, Inc.b9bc6bbb-31c5-427e-e053-2995a90a5f172025-04-29WarningsExact identifier
application number: M032
AntiDandruffShampooConditioner365 ANTI DANDRUFF SHAMPOO CONDITIONER 2 IN 1Whole Foods Market, Inc.c3f5b5fb-acb0-a904-e053-2995a90a56232025-04-29WarningsExact identifier
application number: M032
UTTSE Anti Fungal Shampoo.ANTI FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.33bebbe9-e0ab-2f7d-e063-6294a90add4e2025-04-27WarningsExact identifier
application number: M032
Psalmonica Hair Growth SerumMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.3380fe6d-e057-401a-e063-6394a90a787a2025-04-24WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3344c97b-8767-3f87-e063-6394a90a4f5d2025-04-21WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3346e2c5-af28-74ad-e063-6394a90abbab2025-04-21WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN66f301bf-8e2e-43ce-b6b8-0983fe795f0117
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD66f301bf-8e2e-43ce-b6b8-0983fe795f0117
209884zinc pyrithione 1 % Medicated ConditionerSY66f301bf-8e2e-43ce-b6b8-0983fe795f0117
209884zinc pyrithione 1 % Medicated ShampooSY66f301bf-8e2e-43ce-b6b8-0983fe795f0117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-153-1541163015315420 mL in 1 BOTTLE, PLASTIC (41163-153-15) 420 ml2006-10-260000-00-00NoNoCurrent
41163-153-3241163015332370 mL in 1 BOTTLE, PLASTIC (41163-153-32) 370 ml2023-10-25NoNoCurrent
41163-153-3541163015335700 mL in 1 BOTTLE, PLASTIC (41163-153-35) 700 ml2006-10-260000-00-00NoNoCurrent
41163-153-4041163015340612 mL in 1 BOTTLE, PLASTIC (41163-153-40) 612 ml2023-10-25NoNoCurrent