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
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
for normal hair
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
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 7 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Smooth and Silky KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4d38902f-a6ae-620f-e063-6394a90ae9322026-03-17WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Shampoo.SALICYLIC ACID 3%RoyceDerm LLC4d2f6e29-5d75-6982-e063-6294a90ada8d2026-03-16WarningsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCCVS Pharmacy, Inc.f286a5fd-7916-49bc-97a1-ad737ac5b14a2026-03-13Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders Itchy ScalpPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company54df1acc-4265-494c-879e-c690184d7ae22026-03-13WarningsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCH E Ba58b9119-2adb-459f-86f4-95df28a430c52026-03-13Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCBetter Living Brands, LLCf90d1fb2-4bd7-4d70-81b4-4541f4e3a3d62026-03-13Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders Smooth and Silky ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4cec08cb-aba5-41ce-e063-6294a90adfdf2026-03-13WarningsExact identifier
application number: M032
OLIVITA MinoxidilMINOXIDILShenzhen Xinxin Yunhai Technology Co., Ltd.4cf37b0b-bbb8-1d9c-e063-6294a90af8182026-03-13WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCNice-Pak Products, LLC3c55b70f-7627-8667-e063-6394a90a5cf82026-03-12Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders 2in1 Classic CleanPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company65a4082f-227b-49bf-b88c-b1c651ed13a02026-03-12WarningsExact identifier
application number: M032
Head and Shoulders Green Apple 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc036c9a6-6507-4037-b97b-1b015dd950c12026-03-12WarningsExact identifier
application number: M032
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.4ca9a661-fa39-ab7f-e063-6294a90aed142026-03-10WarningsExact identifier
application number: M032
iBeaLee 5% Minoxidil Hair Regrowth Treatment5% MINOXIDILShenzhen Earth Surface Trading Co., Ltd.4cb728d0-6abe-6645-e063-6394a90acb4c2026-03-10WarningsExact identifier
application number: M032
DHS TarCOAL TARPerson and Covey4c5f7278-c53a-cef6-e063-6394a90a00082026-03-09WarningsExact identifier
application number: M032
DHS ZINCPYRITHIONE ZINCPerson and Covey4c98c0af-c3d0-211e-e063-6294a90a8e122026-03-09WarningsExact identifier
application number: M032
DHS SALSALICYLIC ACIDPerson and Covey4c9b75b5-9c7d-c4a8-e063-6394a90a4a6b2026-03-09WarningsExact identifier
application number: M032
DHS BODY WASHZINC PYRITHIONE WASHPerson and Covey4c9d5b33-9a1e-9db1-e063-6294a90adbae2026-03-09WarningsExact identifier
application number: M032
BiotinBIOTINShenzhen yuehaotong Technology Co.,Ltd4c6ec616-a84e-6e1a-e063-6294a90a2aae2026-03-07WarningsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCOld East Main Co.5368b466-a804-471c-8287-0dd120c0d5092026-03-03Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCAmazon.com Services LLCc187bb79-8190-4a3d-a966-af74198ee5462026-03-03Warnings, Adverse reactionsExact 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