Dandruff

Product NDC: 41163-024
11-digit product format: 411630024
Labeler code: 41163
Product ID: 41163-024_4b06c184-4d5b-4838-e063-6294a90a8176
Type: HUMAN OTC DRUG
Nonproprietary name: PYRITHIONE ZINC
Dosage form: LOTION/SHAMPOO
Route: TOPICAL
Labeler: United Natural Foods, Inc. dba UNFI
Application: M032
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-10-26
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41163-024	41163-024-15	D	Discontinued by firm		2026-10-05
excluded package	package	41163-024	41163-024-35	D	Discontinued by firm		2026-10-05

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 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41163-024-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41163-024-35	`d630ba8d3edf…`	`732f749b63fb…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	41163-024-35	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	41163-024-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	41163-024-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	41163-024-32	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
d7c4507e-7f74-4bcd-9b0e-0b097193a1a8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41163-024-15	Dandruff	420 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	420	16
41163-024-32	Dandruff	370 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	370	16
41163-024-35	Dandruff	700 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	700	16
41163-024-40	Dandruff	612 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	612	16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
AMODIMETHICONE (800 CST)	INACTIVE INGREDIENT	363Z2T48P7	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
GLYCOL DISTEARATE	INACTIVE INGREDIENT	13W7MDN21W	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)	INACTIVE INGREDIENT	B16G315W7A	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
MAGNESIUM CARBONATE HYDROXIDE	INACTIVE INGREDIENT	YQO029V1L4	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
SODIUM XYLENESULFONATE	INACTIVE INGREDIENT	G4LZF950UR	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1
ZINC CARBONATE	INACTIVE INGREDIENT	EQR32Y7H0M	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [SUPERVALUE INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-024	DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [UNITED NATURAL FOODS, INC. DBA UNFI]	14	Current NDC, Legacy NDC, 4 package rows	20250429_d7c4507e-7f74-4bcd-9b0e-0b097193a1a8.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 26 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
As I Am Dry and Itchy Scalp Care	PYRITHIONE ZINC	Salon Commodities, Inc.	71ea4820-4160-41c2-e053-2a95a90a127d	2024-10-09	Warnings	Exact identifier application number: M032
As I Am Dry and Itchy Scalp Care Co Wash	PYRITHIONE ZINC	Salon Commodities, Inc.	71edee79-87ed-ff7c-e053-2995a90ae130	2024-10-09	Warnings	Exact identifier application number: M032
Vanicream Z-Bar	PYRITHIONE ZINC	Pharmaceutical Specialties, Inc.	21c84000-5d08-ae53-e063-6294a90a2362	2024-10-03	Warnings	Exact identifier application number: M032
Head and Shoulders Classic Clean Dandruff	PYRITHIONE ZINC	Navajo Manufacturing Company Inc	3886d51a-b946-4862-a237-e8232df95637	2024-10-02	Warnings	Exact identifier application number: M032
CVS Daily Dandruff Anti-dandruff	PYRITHIONE ZINC	CVS Health	705f5ced-a245-42c8-a32f-baaddaa11c6e	2024-09-27	Warnings	Exact identifier application number: M032
CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SALICYLIC ACID	CVS Health	bd32def7-b002-4e12-89ad-b7d13754d82a	2024-09-24	Warnings	Exact identifier application number: M032
CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruff	SELENIUM SULFIDE	CVS Health	cff51af6-84de-4ba5-ac99-9bc42a65c9a5	2024-09-24	Warnings	Exact identifier application number: M032
VERB PRODUCTS Balance Relief Salicylic Acid Dandruff Clinical Strength	SALICYLIC ACID	Verb Products Inc.	18bddd16-e001-445c-9647-801defc1d527	2024-09-03	Warnings	Exact identifier application number: M032
Denorex Severe Itch	COAL TAR	Neoteric Cosmetics, Inc.	213ccbc4-2f52-58b6-e063-6294a90ae248	2024-09-03	Warnings	Exact identifier application number: M032
SORARESAL	SALICYLIC ACID	Summer Herbal Inc.	af734362-057b-4011-bf4e-c4e4dd67f68c	2024-09-03	Warnings	Exact identifier application number: M032
ion 2 in 1 anti-dandruff Anti-dandruff	PYRITHIONE ZINC	Arcadia Beauty Labs LLC	38631b45-b222-4a25-8180-25970dabdffc	2024-08-28	Warnings	Exact identifier application number: M032
TopCare Therapeutic Anti-Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Topco Associates LLC	070a5249-0b37-4b7f-a55b-609a0d8504d2	2024-08-22	Warnings	Exact identifier application number: M032
J1003005 Jason Dandruff Relief	SULFUR, SALICYLIC ACID	The Hain Celestial Group, Inc.	625e8306-78c4-3317-e053-2991aa0afe81	2024-07-31	Warnings	Exact identifier application number: M032
Jason Dandruff Relief Treatment 2 in 1	ZINC PYRITHIONE	The Hain Celestial Group, Inc	4afa1048-7a76-4562-8dcf-9252d5bfa48a	2024-07-31	Warnings	Exact identifier application number: M032
Alba Natural Acnedote Astringent	SALICYLIC ACID	The Hain Celestial Group, Inc.	939f90e7-e1de-4ca3-a484-90f1b87797d6	2024-07-31	Warnings	Exact identifier application number: M032
Matrix Biolage ScalpSync Antidandruff	PYRITHIONE ZINC	L'Oreal USA Products Inc	8564f2cf-b680-4e2c-8451-f345c9852c1a	2024-07-18	Warnings	Exact identifier application number: M032
Pete and Pedro Control Anti Itch Dandruff	COAL TAR	PETE AND PEDRO LLC	34ec83c1-31b9-4ecc-8bd2-898fd85364ba	2024-07-02	Warnings	Exact identifier application number: M032
VICHY LABORATOIRES DERCOS Selenium Sulfide Anti-Dandruff	SELENIUM SULFIDE, MICRONIZED	L'Oreal USA Products Inc	deae26e0-53f0-442b-959c-0f925a102db0	2024-06-25	Warnings	Exact identifier application number: M032
VICHY LABORATOIRES Dercos Selenium Sulfide Anti-dandruff	SELENIUM SULFIDE, MICRONIZED	PRODUCTOS CAPILARES L'OREAL SA	3fcb03fc-552a-4b02-981e-2ff84142da96	2024-06-25	Warnings	Exact identifier application number: M032
Dercos Salicylic Acid Anti-Dandruff Serum	SALICYLIC ACID	PRODUCTOS CAPILARES L'OREAL SA	024f9299-ee6c-48e3-89e7-96b7db060c30	2024-06-20	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	d7c4507e-7f74-4bcd-9b0e-0b097193a1a8	16
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	d7c4507e-7f74-4bcd-9b0e-0b097193a1a8	16
209884	zinc pyrithione 1 % Medicated Conditioner	SY	d7c4507e-7f74-4bcd-9b0e-0b097193a1a8	16
209884	zinc pyrithione 1 % Medicated Shampoo	SY	d7c4507e-7f74-4bcd-9b0e-0b097193a1a8	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-024-15	41163002415	420 mL in 1 BOTTLE, PLASTIC (41163-024-15)	420 ml	2006-10-26	0000-00-00	No	No	Current
41163-024-32	41163002432	370 mL in 1 BOTTLE, PLASTIC (41163-024-32)	370 ml	2023-11-02		No	No	Current
41163-024-35	41163002435	700 mL in 1 BOTTLE, PLASTIC (41163-024-35)	700 ml	2006-10-26	0000-00-00	No	No	Current
41163-024-40	41163002440	612 mL in 1 BOTTLE, PLASTIC (41163-024-40)	612 ml	2023-11-02		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Equaline 311.007/311AK-AN Dandruff Shampoo, Everyday Clean 2 in 1	United Natural Foods, Inc. dba UNFI \| Nice-Pak Products, LLC	2026-02-17	HUMAN OTC DRUG LABEL	16