Dandruff

Product NDC
36800-281
11-digit product format
368000281
Labeler code
36800
Product ID
36800-281_4ab840bf-041c-42d4-e063-6294a90a9d4b
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-05-28
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 packagepackage36800-28136800-281-15DDiscontinued 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
706b856c-ce89-4860-bc5d-9803deb469e7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-281-15Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO42015
36800-281-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO37015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
AMMONIUM LAURETH-3 SULFATEINACTIVE INGREDIENT896SJ235FNDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
AMODIMETHICONE (800 CST)INACTIVE INGREDIENT363Z2T48P7DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBPDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21WDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)INACTIVE INGREDIENTB16G315W7ADANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
MAGNESIUM CARBONATE HYDROXIDEINACTIVE INGREDIENTYQO029V1L4DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFADANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950URDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
TRIDECETH-12INACTIVE INGREDIENTYFY3KG5Y7ODANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1
ZINC CARBONATEINACTIVE INGREDIENTEQR32Y7H0MDANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-281DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]13Current NDC, Legacy NDC, 2 package rows20250519_706b856c-ce89-4860-bc5d-9803deb469e7.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 ShampooPSN706b856c-ce89-4860-bc5d-9803deb469e715
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD706b856c-ce89-4860-bc5d-9803deb469e715
209884zinc pyrithione 1 % Medicated ConditionerSY706b856c-ce89-4860-bc5d-9803deb469e715
209884zinc pyrithione 1 % Medicated ShampooSY706b856c-ce89-4860-bc5d-9803deb469e715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-281-1536800028115420 mL in 1 BOTTLE, PLASTIC (36800-281-15) 420 ml2002-05-280000-00-00NoNoCurrent
36800-281-3236800028132370 mL in 1 BOTTLE, PLASTIC (36800-281-32) 370 ml2023-01-25NoNoCurrent