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 firm2026-09-14

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 1 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Classic Clean DandruffPYRITHIONE ZINCCARDINAL HEALTH 110, LLC. DBA LEADER5b22537d-d09c-5bd6-e063-6294a90a48ff2026-09-10WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Pure Clean 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cc726c2-3747-6dbf-e063-6294a90a789f2026-09-09WarningsExact identifier
application number: M032
Leader Maximum Strength Therapeutic DandruffSALICYLIC ACIDCARDINAL HEALTH 110, LLC. DBA LEADER5afb2260-5b50-de95-e063-6394a90a5a472026-09-08WarningsExact identifier
application number: M032
ANTI-DANDRUFFKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.5ac93feb-eb6d-7563-e063-6294a90ad2e02026-09-05WarningsExact identifier
application number: M032
Dr Marvel ANTI DANDRUFF SCALP SERUMSELENIUM SULFIDE SALICYLIC ACIDGuangzhou Liyan Cosmetics Technology Co., Ltd.5aaeddff-72f9-3687-e063-6394a90ae5dc2026-09-04WarningsExact identifier
application number: M032
Head and Shoulders Scalp Restore Nourishing ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5a834d00-cc79-1a8e-e063-6294a90ab2452026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Purify Clarifying Pre-ShampooSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a84c545-4570-b078-e063-6394a90a8c5a2026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Purify VolumizingSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a8627ec-cfd8-d0f6-e063-6394a90ab4882026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Soothe CoolingSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a87ed71-87e7-a7b7-e063-6294a90ac8972026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Restore NourishingPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5a8a42d2-8610-1dfb-e063-6294a90abc7a2026-09-02WarningsExact identifier
application number: M032
Koi Beauty 5% Minoxidil Hair Growth Kit5% MINOXIDIL HAIR GROWTH KITBeijing Sea Heart International Science And Technology Co.,Ltd.3b34f263-1232-4bb9-e063-6294a90a494d2026-08-27WarningsExact identifier
application number: M032
SMOOTH AND SOFT DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC9e235139-07a2-469a-8601-db69379ce3472026-08-24WarningsExact identifier
application number: M032
ITCHY SCALP RELIEF DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC634019c2-03a3-4fed-939e-6f9a50ddea7b2026-08-24WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b4f9e3-c241-6a70-e063-6294a90a364f2026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b52a52-dab0-87b5-e063-6294a90a05962026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b67ce0-3546-c18a-e063-6394a90ae50a2026-08-23WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.599f2cce-0c27-d425-e063-6394a90a15652026-08-22WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.59a0a062-92d1-210a-e063-6394a90a9bf92026-08-22WarningsExact identifier
application number: M032
Ouai Anti-DandruffSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5990c45f-f653-b403-e063-6394a90a329d2026-08-21WarningsExact identifier
application number: M032
Dermatology Psoriasis CreamCOAL TARG.M.J Natural Products, Inc.96cc5455-f3b8-4ded-a158-5de209d7bf0d2026-08-21WarningsExact 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