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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-281	36800-281-15	D	Discontinued by firm		2026-10-16

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
Ingredient	Strength
PYRITHIONE ZINC	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R953O2RHZ5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
209884	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
706b856c-ce89-4860-bc5d-9803deb469e7	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-281-15	Dandruff	420 mL in 1 BOTTLE, PLASTIC	SHAMPOO	420		15
36800-281-32	Dandruff	370 mL in 1 BOTTLE, PLASTIC	SHAMPOO	370		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
AMMONIUM LAURETH-3 SULFATE	INACTIVE INGREDIENT	896SJ235FN	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
AMODIMETHICONE (800 CST)	INACTIVE INGREDIENT	363Z2T48P7	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
CETRIMONIUM CHLORIDE	INACTIVE INGREDIENT	UC9PE95IBP	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
GLYCOL DISTEARATE	INACTIVE INGREDIENT	13W7MDN21W	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)	INACTIVE INGREDIENT	B16G315W7A	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
MAGNESIUM CARBONATE HYDROXIDE	INACTIVE INGREDIENT	YQO029V1L4	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
SODIUM XYLENESULFONATE	INACTIVE INGREDIENT	G4LZF950UR	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
TRIDECETH-12	INACTIVE INGREDIENT	YFY3KG5Y7O	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1
ZINC CARBONATE	INACTIVE INGREDIENT	EQR32Y7H0M	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-281	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	13	Current NDC, Legacy NDC, 2 package rows	20250519_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 21 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neutrogena Scalp Therapy Anti-Dandruff Extra Strength	SALICYLIC ACID	Kenvue Brands LLC	ca49fd70-f0d3-3375-e053-2a95a90af835	2025-03-10	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Men Coastal Tide	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	20d3208c-d22b-84f1-e063-6394a90ab610	2025-03-06	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Nourish and Smooth Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	86abb2ee-6b35-32eb-e053-2a91aa0a8bc6	2025-03-03	Warnings	Exact identifier application number: M032
Cantu Guava Ginger Anti Dandruff	SALICYLIC ACID	PDC Brands	d43a540b-bea5-2055-e053-2995a90a25fb	2025-03-03	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 MenTimber Old Spice	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	2d7ff3d8-d142-9537-e063-6294a90ab02c	2025-02-06	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Clinical Strength Dry Scalp Rescue	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	2d041983-5750-e0f1-e063-6394a90a5b9e	2025-01-31	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Men Vanilla and Amber	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	2cf441e0-3ddd-0f9e-e063-6394a90a092c	2025-01-30	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Men Advanced Series Full and Thick	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7d3f0664-a9e7-6b63-e053-2991aa0a4b0a	2025-01-29	Warnings	Exact identifier application number: M032
Head and Shoulders Dry Scalp Care Dual Pack	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	2cdb1e94-3923-84f7-e063-6394a90a07d5	2025-01-29	Warnings	Exact identifier application number: M032
Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	2cc7724c-a1f1-a42d-e063-6394a90a83cf	2025-01-28	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Men Advanced Series Swagger Old Spice	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7d3cca83-f99e-2c30-e053-2991aa0a4c9d	2025-01-28	Warnings	Exact identifier application number: M032
Head and Shoulders Clinical Strength Advanced Oil Control	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	2ccaceed-9928-ef05-e063-6394a90a6511	2025-01-28	Warnings	Exact identifier application number: M032
Head and Shoulders Bare Minimal Ingredients Soothing Hydration	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	003d1723-1fd9-ef2b-e063-6294a90aafda	2025-01-28	Warnings	Exact identifier application number: M032
QC Anti Dandruff T Plus	COAL TAR	Guangzhou Danting Bath&Body Care Industry Co. Ltd.	2c7630ab-b7fa-462c-e063-6394a90a30bb	2025-01-24	Warnings	Exact identifier application number: M032
Quality Choice Dandruff 2 in 1	PYRITHIONE ZINC	Guangzhou Danting Bath&Body Care Industry Co. Ltd	2c762c86-ba7a-1976-e063-6394a90a49f2	2025-01-24	Warnings	Exact identifier application number: M032
Quality Choice Dandruff Dry Scalp Care	PYRITHIONE ZINC	CHAIN DRUG MARKETING ASSOCIATION, INC.	2c764242-df65-7383-e063-6394a90a34b0	2025-01-24	Warnings	Exact identifier application number: M032
Quality Choice Dandruff Everyday Clean	PYRITHIONE ZINC	CHAIN DRUG MARKETING ASSOCIATION, INC.	2c767d79-6ffe-ebaa-e063-6394a90a39d1	2025-01-24	Warnings	Exact identifier application number: M032
Quality Choice Dandruff Everyday Clean	PYRITHIONE ZINC	Guangzhou Danting Bath&Body Care Industry Co. Ltd	2c77edae-be2b-3a37-e063-6294a90a001d	2025-01-24	Warnings	Exact identifier application number: M032
Quality Choice Dandruff Dry Scalp Care	PYRITHIONE ZINC	Guangzhou Danting Bath&Body Care Industry Co. Ltd.	2c77e4b6-5a65-c7ea-e063-6394a90a6abb	2025-01-24	Warnings	Exact identifier application number: M032
Zincon Medicated Anti-Dandruff	PYRITHIONE ZINC	Neoteric Cosmetics, Inc.	2c26bd1e-35d4-f1a2-e063-6294a90af576	2025-01-23	Warnings	Exact identifier application number: M032

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R953O2RHZ5	PYRITHIONE ZINC	13463-41-7	PYRITHIONE ZINC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
209884	zinc pyrithione 1 % Medicated Shampoo	PSN	706b856c-ce89-4860-bc5d-9803deb469e7	15
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	706b856c-ce89-4860-bc5d-9803deb469e7	15
209884	zinc pyrithione 1 % Medicated Conditioner	SY	706b856c-ce89-4860-bc5d-9803deb469e7	15
209884	zinc pyrithione 1 % Medicated Shampoo	SY	706b856c-ce89-4860-bc5d-9803deb469e7	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-281-15	36800028115	420 mL in 1 BOTTLE, PLASTIC (36800-281-15)	420 ml	2002-05-28	0000-00-00	No	No	Current
36800-281-32	36800028132	370 mL in 1 BOTTLE, PLASTIC (36800-281-32)	370 ml	2023-01-25		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Top Care 281.007/281AN Dandruff Shampoo, Dry Scalp	Topco Associates LLC \| Nice-Pak Products, LLC	2026-02-13	HUMAN OTC DRUG LABEL	15