XtraCare Anti-Dandruff Hair Cleanse

Product NDC
57337-024
11-digit product format
573370024
Labeler code
57337
Product ID
57337-024_126c756d-69d4-085d-e063-6294a90ae640
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
2026-12-31
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
Coconut and Shea Butter
Listing expiration
2026-12-31

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
7d9bf611-db24-4915-9b13-b7b36f47711fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-024-012024-02-28C16284748780-11030e365-335a-111a-e063-dadaa90a10e2XtraCare Anti-Dandruff Hair Cleanse
57337-024-012024-01-30C16284748780-11030e365-335a-111a-e063-dadaa90a10e2XtraCare Anti-Dandruff Hair Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-024-01XtraCare Anti-Dandruff Hair CleanseCoconut and Shea Butter400 mg in 1 BOTTLESHAMPOO4004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5XTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5XTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
.BETA.-D-GLUCOPYRANOSEINACTIVE INGREDIENTJ4R00M814DXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
COCOS NUCIFERA WHOLEINACTIVE INGREDIENT245J88W96LXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0XTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-024XTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]4Current NDC, Legacy NDC, 1 package rows20240229_7d9bf611-db24-4915-9b13-b7b36f47711f.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 20 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Koi Beauty 5% Minoxidil Hair Growth Serum5% MINOXIDIL HAIR GROWTH SERUMBeijing Sea Heart International Science And Technology Co.,Ltd.358dfbcd-6152-2842-e063-6394a90a2ab42025-05-20WarningsExact 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
Structure of Skin Soothing Anti-DandruffPYRITHIONE ZINCSTRUCTURE OF SKIN LLC3311fa83-a06b-b379-e063-6394a90ae2692025-04-18WarningsExact identifier
application number: M032
LILIVERA Hair Regrowth KitMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.330602da-ec17-5a35-e063-6394a90a741b2025-04-17WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company3272a482-3813-63e4-e063-6394a90a43eb2025-04-10WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse for normal hairPYRITHIONE ZINCRejoice International Inc.b90e574c-933c-4f86-aadc-567ffbe6ea042025-04-09WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse for sensitive hairPYRITHIONE ZINCRejoice International Inc.979394c2-5681-44c8-a43c-bf3a392bd0c12025-04-09WarningsExact identifier
application number: M032
LEAHUE MADHUCA TONICSALICYLIC ACIDBio-interchange Co.31ee4645-0f64-f7a0-e063-6394a90a17362025-04-04WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-024-0157337002401400 mg in 1 BOTTLE (57337-024-01) 400 mg2013-10-090000-00-00NoNoCurrent