Dandruff

Product NDC
53942-281
11-digit product format
539420281
Labeler code
53942
Product ID
53942-281_5cc89108-ec0a-f37b-e063-6294a90a27e1
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Demoulas Super Markets, Inc
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-01-30
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 packagepackage53942-28153942-281-15DDiscontinued by firm2026-10-21

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 · 1 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 packagepackage53942-28153942-281-15DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-281-15Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO42012
53942-281-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO37012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
AMODIMETHICONE (800 CST)INACTIVE INGREDIENT363Z2T48P7DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXDANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21WDANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)INACTIVE INGREDIENTB16G315W7ADANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
MAGNESIUM CARBONATE HYDROXIDEINACTIVE INGREDIENTYQO029V1L4DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNDANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFADANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950URDANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RDANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2
ZINC CARBONATEINACTIVE INGREDIENTEQR32Y7H0MDANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-281DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]10Current NDC, Legacy NDC, 2 package rows20250406_584df95a-7fc7-4b4b-b703-c423248444ed.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 23 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaharmony Face and BodyPYRITHIONE ZINCD3 Development, Inc.bd72b53c-b22c-40d0-e053-2995a90af9c12024-12-20WarningsExact identifier
application number: M032
Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.637851c6-ff4a-8bbc-e053-2991aa0a963c2024-12-20WarningsExact identifier
application number: M032
Dermaharmony Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.cb442483-b735-01a0-e053-2995a90aaff52024-12-20WarningsExact identifier
application number: M032
Dermaharmony Pyrithione Zinc with Shea ButterPYRITHIONE ZINCD3 Development, Inc.dc7ba02c-bdbd-5136-e053-2995a90ac5452024-12-20WarningsExact identifier
application number: M032
Dermaharmony Tea Tree BarPYRITHIONE ZINCD3 Development, Inc.e9d5eb14-1840-ae21-e053-2a95a90aa3212024-12-20WarningsExact identifier
application number: M032
Dermaharmony Unscented BarPYRITHIONE ZINCD3 Development, Inc.e9d66c9c-5fb1-0a90-e053-2a95a90ab7a42024-12-20WarningsExact identifier
application number: M032
BYE-BYE CRADLE CAPPYRITHIONE ZINCTubby Toddf4398ad2-7da5-aff0-e053-2995a90ae2662024-12-12WarningsExact identifier
application number: M032
NATURALTECH PURIFYING ANTI-DANDRUFFPYRITHIONE ZINCDavines S.p.A.1f7e0265-0543-4ef9-addf-4d514d0eedfe2024-12-11WarningsExact identifier
application number: M032
NATURALTECH PURIFYING ANTI-DANDRUFFSELENIUM SULFIDEDavines S.p.A.369a24fd-3882-4fad-b57a-45806090aff12024-12-11WarningsExact identifier
application number: M032
Skin Renewing CreamSALICYLIC ACIDAllure Labsb5ea8f33-8f18-7464-e053-2a95a90a39b22024-12-09WarningsExact identifier
application number: M032
Skin Renewing CreamSALICYLIC ACIDAllure Labsfa54cf42-3ba7-b7b3-e053-6394a90aa7a02024-12-09WarningsExact identifier
application number: M032
Satinique Anti Dandruff Scalp and HairSALICYLIC ACIDAccess Business Group LLC03252c61-c51b-4e87-a06d-a61b8393704f2024-12-09WarningsExact identifier
application number: M032
Dry Skin Relief BarSALICYLIC ACIDCP Skin Health Group, Inc.eceb73b0-4c2f-4989-a3aa-a6553bc682522024-12-09WarningsExact identifier
application number: M032
Head and Shoulders Dual Pack Green ApplePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc8208bac-9d32-7694-e053-2a95a90a746c2024-11-27WarningsExact identifier
application number: M032
VanicreamPYRITHIONE ZINCPharmaceutical Specialties, Inc.d124a093-f739-0666-e053-2995a90a52ed2024-11-27WarningsExact identifier
application number: M032
LEAHUE MADHUCA TONICSALICYLIC ACIDBio-interchange Co.81454c8a-ddcf-7cef-e053-2991aa0a53c22024-11-27WarningsExact identifier
application number: M032
Hairitage Wash It Away Anti-Dandruff for Oily, Flaky ScalpSELENIUM SULFIDEMaesa, LLC.b09c3b0d-564e-45e4-b6ff-c1f0c12a95212024-11-13WarningsExact identifier
application number: M032
Hairitage Wash It Away Anti-Dandruff for Dry, Flaky ScalpSELENIUM SULFIDEMaesa, LLC.fa5d4ee3-fbeb-4379-bbd3-2b5b2cc454302024-11-12WarningsExact identifier
application number: M032
Marcs 2 in 1 Everyday Care Dandruff Anti-DandruffPYRITHIONE ZINCMark Glassman, Inc.1daaa2c9-fbc7-4aa5-9772-e157109320662024-11-11WarningsExact identifier
application number: M032
Marcs Dry Scalp Care Dandruff Anti-DandruffPYRITHIONE ZINCMark Glassman, Inc.ffab6ca6-7c8f-4080-836c-635a6ba3c0bb2024-11-11WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN584df95a-7fc7-4b4b-b703-c423248444ed12
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD584df95a-7fc7-4b4b-b703-c423248444ed12
209884zinc pyrithione 1 % Medicated ConditionerSY584df95a-7fc7-4b4b-b703-c423248444ed12
209884zinc pyrithione 1 % Medicated ShampooSY584df95a-7fc7-4b4b-b703-c423248444ed12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53942-281-1553942028115420 mL in 1 BOTTLE, PLASTIC420 mlHistorical
53942-281-3253942028132370 mL in 1 BOTTLE, PLASTIC (53942-281-32) 370 ml2023-11-01NoNoCurrent