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 28 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XtraCare Anti-Dandruff Conditioner Coconut and Shea Butter	PYRITHIONE ZINC	Rejoice International Inc.	e69319c8-c49c-415b-a7ea-ec6e77fa625c	2024-02-28	Warnings	Exact identifier application number: M032
XtraCare Anti-Dandruff Conditioner mint and eucalyptus	PYRITHIONE ZINC	Rejoice International Inc.	08330f44-45e2-47cb-bd2e-cef15ba61aee	2024-02-28	Warnings	Exact identifier application number: M032
XtraCare Anti-Dandruff Hair Cleanse Coconut and Shea Butter	PYRITHIONE ZINC	Rejoice International Inc.	7d9bf611-db24-4915-9b13-b7b36f47711f	2024-02-28	Warnings	Exact identifier application number: M032
XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptus	PYRITHIONE ZINC	Rejoice International Inc.	b05742fe-692f-45a3-9de0-5f3f08642d78	2024-02-28	Warnings	Exact identifier application number: M032
XtraCare Dandruff Hair Wash	SALICYLIC ACID	Rejoice International	1902e6bb-e829-4b1a-b85a-1394913c77ca	2024-02-28	Warnings	Exact identifier application number: M032
amazon basics maximum strength dandruff Anti-dandruff	SELENIUM SULFIDE	AMAZON.COM SERVICES LLC	194e4c51-ff7b-4def-a71d-efa5dfca3efd	2024-02-26	Warnings	Exact identifier application number: M032
Doo Gro Braids Twists Locs Dandruff Control Moisturizing	SALICYLIC ACID	J. Strickland and Co.	116f4f0d-66c7-49dd-e063-6394a90ab2b5	2024-02-15	Warnings	Exact identifier application number: M032
amazon basics therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	AMAZON.COM SERVICES LLC	ada1be0c-53a7-443c-bc3c-f7a26b5f96a9	2024-02-05	Warnings	Exact identifier application number: M032
Equate Dry Scalp 2 in 1 Dandruff Anti-Dandruff	PYRITHIONE ZINC	Wal-Mart Stores, Inc.	6440fdd9-daa8-4f15-bdee-33724993bd7b	2024-02-01	Warnings	Exact identifier application number: M032
Equate Everyday Clean Dandruff Anti-Dandruff	PYRITHIONE ZINC	Wal-Mart Stores, Inc.	4c84a67a-1f43-4f40-a172-271de7e76785	2024-01-29	Warnings	Exact identifier application number: M032
Equate Everyday Clean 2 in 1 Dandruff Anti-Dandruff	PYRITHIONE ZINC	Wal-Mart Stores, Inc.	c85095f2-5dbd-4822-a83a-dc3641c4a330	2024-01-29	Warnings	Exact identifier application number: M032
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	Dynarex Corporation	81dff9df-6f7e-49f0-e053-2a91aa0af7e7	2024-01-23	Warnings	Exact identifier application number: M032
Walgreens Original T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Walgreen Company	42cc63ab-6f79-4544-8529-7b8c36021b18	2024-01-22	Warnings	Exact identifier application number: M032
True plus Real Therapeutic T plus Plus Original Strength Tar Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Garcoa, Inc.	1f4c23d5-ca00-4387-abc7-59d9ef471977	2024-01-22	Warnings	Exact identifier application number: M032
Walgreens Extra Strength T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Walgreen Company	7f681386-976c-40f4-8b18-97413989ab78	2024-01-22	Warnings	Exact identifier application number: M032
Prosoria Medicated	SELENIUM SULFIDE	Nuvothera, Inc.	44eaaeb0-1400-4697-85d0-e8c2282c1cba	2024-01-11	Warnings	Exact identifier application number: M032
Prosoria Scalp	SALICYLIC ACID	Nuvothera, Inc.	52a98715-3e57-4b86-b91e-0ce433dc22bd	2024-01-10	Warnings	Exact identifier application number: M032
Prosoria Psoriasis Treatment	SALICYLIC ACID	Nuvothera, Inc.	f94f4481-c58e-4555-9863-cbaa2c4cdd07	2024-01-10	Warnings	Exact identifier application number: M032
Equate Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Wal-Mart Stores, Inc.	408d57e4-a707-4826-a04c-99517dc9b5af	2024-01-04	Warnings	Exact identifier application number: M032
Equate Extra Strength Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Wal-Mart Stores, Inc.	986ac1ab-c7c3-40df-b41b-6f26cce22a43	2024-01-04	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