FDA.reportPublic FDA data

Dandruff

Product NDC
36800-281
Requested package NDC
36800-281-15
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 firm2026-08-10

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 1 of 31 · 617 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast ReliefPYRITHIONE ZINCRida LLCd1e4dee7-5962-4ec1-ab99-9d547077b2f22026-08-05WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief TreatmentSALICYLIC ACIDRida LLC6226ce12-432f-402e-bda7-a5ca96f0b8382026-08-05WarningsExact identifier
application number: M032
JOHNSON FOAMMINOXIDILJOHNSON BIOPHARMACEUTICAL INC.1d44a75c-c940-680c-e063-6394a90a58392026-08-02WarningsExact identifier
application number: M032
FOLKI COSMETIC Psoriasis CreamSALICYLIC ACID 3% PSORIASIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.575786e0-21b8-ad9d-e063-6394a90ad0d42026-07-24WarningsExact identifier
application number: M032
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M032
Pureskin Seborrheic Dermatitis and Psoriasis CreamSEBORRHEIC DERMATITIS PSORIASIS CREAMBENLONG HALL LLC36086f7f-8536-417f-a302-37f78288489e2026-07-20WarningsExact identifier
application number: M032
5%MINOXIDIL TOPICAL FOAMMINOXIDILVeloce Trading Co., Limited56f87881-653f-17e6-e063-6294a90a67872026-07-19WarningsExact identifier
application number: M032
ProBliva Psoriasis Shampoo.SALICYLIC ACID 3%CAVTECH HOLDING LLC563e75f9-a1e2-2796-e063-6294a90aedb42026-07-10WarningsExact identifier
application number: M032
ProBliva Anti Dandruff Shampoo.SELENIUM SULFIDE 1%CAVTECH HOLDING LLC56022f6b-d7ba-1ccd-e063-6294a90a73102026-07-07WarningsExact identifier
application number: M032
Antifungal Psoriasis Shampoo.SALICYLIC ACID 2%Trovina Co. Ltd5512ac82-e3c5-37e6-e063-6294a90a92d62026-07-01WarningsExact identifier
application number: M032
Anti-fungalANTI-FUNGAL SHAMPOOShenzhen Chaoxiji Technology Co.,Ltd.555cb4fa-6f59-fa69-e063-6394a90a1db62026-06-28WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC55246263-7345-ba65-e063-6294a90ab1632026-06-26WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc552926da-0dfb-4248-e063-6294a90ab4a82026-06-26WarningsExact identifier
application number: M032
Dermoia Seborrheic Dermatitis Selenium SulfideSELENIUM SULFIDETREASUREWISE LLC04b8532e-44a7-4eaf-a46d-87611ec93c242026-06-23WarningsExact identifier
application number: M032
Dermgentle Seborrheic Scalp SerumPYRITHIONE ZINCDermgentle LLC54a0901a-404f-ea0e-e063-6294a90a6dc72026-06-19WarningsExact identifier
application number: M032
Silvagle Selenium Sulfide Anti DandruffShampooSELENIUM SULFIDEGUANGZHOU BAOSIJIE BIOTECHNOLOGY CO., LTD54885ae3-7e2f-7bd2-e063-6394a90a97fe2026-06-18WarningsExact identifier
application number: M032
Pharmlitalia Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd845a82f6-7d0e-416d-b5b0-bf788dca2f542026-06-18WarningsExact identifier
application number: M032
anti dandruff SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD5459e831-41e7-f1c7-e063-6394a90ae0982026-06-16WarningsExact identifier
application number: M032
ANTI DANDRUFF SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD545780f9-a202-95e9-e063-6394a90a982f2026-06-15WarningsExact identifier
application number: M032
Anti-DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.543a431f-21fb-df9e-e063-6394a90a6c362026-06-14WarningsExact 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