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 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

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