XtraCare Anti-Dandruff Hair Cleanse

Product NDC: 57337-028
11-digit product format: 573370028
Labeler code: 57337
Product ID: 57337-028_326589b6-e988-685f-e063-6394a90a77b3
Type: HUMAN OTC DRUG
Nonproprietary name: PYRITHIONE ZINC
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Rejoice International Inc.
Application: M032
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-10-09
Substance: PYRITHIONE ZINC
Active strength: 20 mg/400mg
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: XtraCare Anti-Dandruff Hair Cleanse
Brand name suffix: for normal hair
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PYRITHIONE ZINC	20 mg/400mg

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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b90e574c-933c-4f86-aadc-567ffbe6ea04	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-028-01	2024-02-28	C162847	48780-1	1030e365-3fbf-111a-e063-dadaa90a10e2	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR
57337-028-01	2024-01-30	C162847	48780-1	1030e365-3fbf-111a-e063-dadaa90a10e2	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-028-01	XtraCare Anti-Dandruff Hair Cleansefor normal hair	400 mg in 1 BOTTLE	SHAMPOO	400		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
.BETA.-D-GLUCOPYRANOSE	INACTIVE INGREDIENT	J4R00M814D	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-028	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	9	Current NDC, Legacy NDC, 1 package rows	20250411_b90e574c-933c-4f86-aadc-567ffbe6ea04.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-028-01	57337002801	400 mg in 1 BOTTLE (57337-028-01)	400 mg	2013-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR	Rejoice International Inc. \| China Ningbo Shangge Cosmetic Technology Corp.	2025-04-09	HUMAN OTC DRUG LABEL	9