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
IngredientStrength
PYRITHIONE ZINC20 mg/400mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R953O2RHZ5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b90e574c-933c-4f86-aadc-567ffbe6ea04Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-028-01XtraCare Anti-Dandruff Hair Cleansefor normal hair400 mg in 1 BOTTLESHAMPOO4009

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
.BETA.-D-GLUCOPYRANOSEINACTIVE INGREDIENTJ4R00M814DXTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LXTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXXTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DXTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKXTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-028XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]9Current NDC, Legacy NDC, 1 package rows20250411_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 19 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMBANNER Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.383926b7-997b-af1e-e063-6394a90a506d2025-06-23WarningsExact identifier
application number: M032
Brickell Mens Products Relieving Anti-DandruffSALICYLIC ACIDBRICKELL BRANDS LLC7ba3b13b-cb78-4df8-8719-c88e556643b42025-06-16WarningsExact identifier
application number: M032
VENROCKPIROCTONE OLAMINE AND SALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.372feca7-f6f1-cd38-e063-6294a90a3bfe2025-06-12WarningsExact identifier
application number: M032
Neutrogena T/Sal TherapeuticSALICYLIC ACIDKenvue Brands LLC54707f0f-6025-4dc3-8be8-7a38bb1363b82025-06-05WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SAaae04d08-9d0c-43bd-89c2-741884de3bea2025-06-04WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDL'Oreal USA Products Incbcffd505-82bd-45ce-9ad0-64a9e63f62b52025-06-04WarningsExact identifier
application number: M032
UCHOIZE S2 Balance Anti-DandruffUCHOIZE S2 BALANCE ANTI-DANDRUFF SHAMPOODreamwise International Corp36a5efa8-0617-868d-e063-6394a90a17052025-06-03WarningsExact identifier
application number: M032
DermaD ATOPIC DERMATITIS TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.d872a4ee-554e-4bca-acb1-3bbf57dc690b2025-05-29WarningsExact identifier
application number: M032
DermaD JOCK ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.c8c0449c-11f9-4434-a91c-b690d67808202025-05-29WarningsExact identifier
application number: M032
DermaD Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.e52c647b-8cdc-4023-af22-fbfb84ea0ada2025-05-27WarningsExact identifier
application number: M032
DermaER Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.f62e6c5e-6e80-4b75-a0b1-c893224d9ce42025-05-27WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Ince71e87ba-2a62-44f3-e053-2995a90a8b112025-05-25WarningsExact identifier
application number: M032
Tagrid ANTI FUNGALZINC PYRITHIONE,SALICYLIC ACIDTAGRID LLC3376b104-1f07-fab3-e063-6394a90a0ca42025-05-22WarningsExact identifier
application number: M032
Coal TarCOAL TARNopsor USA Distribution Co., Inc.407bd007-bec6-2864-e054-00144ff88e882025-05-05WarningsExact identifier
application number: M032
AntiDandruffShampoo365 ANTI DANDRUFF SHAMPOOWhole Foods Market, Inc.b9bc6bbb-31c5-427e-e053-2995a90a5f172025-04-29WarningsExact identifier
application number: M032
AntiDandruffShampooConditioner365 ANTI DANDRUFF SHAMPOO CONDITIONER 2 IN 1Whole Foods Market, Inc.c3f5b5fb-acb0-a904-e053-2995a90a56232025-04-29WarningsExact identifier
application number: M032
UTTSE Anti Fungal Shampoo.ANTI FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.33bebbe9-e0ab-2f7d-e063-6294a90add4e2025-04-27WarningsExact identifier
application number: M032
Psalmonica Hair Growth SerumMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.3380fe6d-e057-401a-e063-6394a90a787a2025-04-24WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3344c97b-8767-3f87-e063-6394a90a4f5d2025-04-21WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3346e2c5-af28-74ad-e063-6394a90abbab2025-04-21WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-028-0157337002801400 mg in 1 BOTTLE (57337-028-01) 400 mg2013-10-090000-00-00NoNoCurrent