FDA.reportPublic FDA data

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 6 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoveSOOTHING MOISTURE DAMAGE THERAPY ANTI-DANDRUFF CONDITIONERConopco d/b/a Unilever4ef55722-df78-0e4c-e063-6294a90a85402026-04-08WarningsExact identifier
application number: M032
Dove Men CareFORTIFYING SHAMPOO AND CONDITIONER ANTI-DANDRUFF 2 IN 1 PYRITHIONE ZINC SHAMPOOConopco d/b/a Unilever4ecf22e8-e318-26f7-e063-6294a90a54772026-04-07WarningsExact identifier
application number: M032
Dove Men CareANTI-DANDRUFF 2IN1 SHAMPOO AND CONDITIONERConopco d/b/a Unilever4ecce67b-b2e0-b757-e063-6294a90a224e2026-04-07WarningsExact identifier
application number: M032
Dove Men CareANTI-DANDRUFF DRYNESS AND ITCH RELIEF 2 IN 1 SHAMPOO AND CONDITONERConopco d/b/a Unilever4edfa86c-0139-5bc5-e063-6294a90a5d732026-04-07WarningsExact identifier
application number: M032
DoveSOOTHING MOISTURE DAMAGE THERAPY ANTI-DANDRUFF SHAMPOOConopco d/b/a Unilever4ecb2eac-0d1c-b59d-e063-6394a90a49e32026-04-06WarningsExact identifier
application number: M032
Happy Head Anti-DandruffPYRITHIONE ZINCHappy Head, Incf0d5daea-72fc-4e40-a390-9da42cadbe3a2026-04-06WarningsExact identifier
application number: M032
DoveCALMING RELIEF DAMAGE THERAPY ANTI-DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONERConopco d/b/a Unilever4ecc1232-065f-c63e-e063-6394a90ac63b2026-04-06WarningsExact identifier
application number: M032
Suave Professionals Men 2 in 1 Classic Clean AntiDandruffPYRITHIONE ZINCConopco Inc. d/b/a Unileverd85e52e5-c3e2-4be0-aa3f-3511a69ecc4f2026-04-03WarningsExact identifier
application number: M032
Denorex Multi-Symptom Anti-DandruffSALICYLIC ACIDNeoteric Cosmetics, Inc.4e904a6b-a732-558b-e063-6294a90ac6422026-04-01WarningsExact identifier
application number: M032
Denorex Extra StrengthSALICYLIC ACIDNeoteric Cosmetics, Inc.21d234ff-f379-4bcd-9ba0-90f27c6d3a692026-04-01WarningsExact identifier
application number: M032
EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00Qingyuan Moksha Biotechnology Co., Ltd.4e386cc8-004a-9742-e063-6394a90a763c2026-03-30WarningsExact identifier
application number: M032
Tio Nacho Anti-DandruffSALICYLIC ACIDGenomma Lab USAc3c92b35-4955-4985-9a1d-8756c1b2131c2026-03-27WarningsExact identifier
application number: M032
Suave Antidandruff 2 IN 1 Classic CleanANTI DANDRUFF 2N1 SHAMPOO AND CONDITIONERSuave Brands Co., LLC41d9cfec-6d14-f620-e063-6294a90a078d2026-03-26WarningsExact identifier
application number: M032
Suave Anti dandruff Coconut MoistureANTI DANDRUFF SHAMPOOSuave Brands Co., LLC41da3d90-4845-0d8f-e063-6294a90aede12026-03-26WarningsExact identifier
application number: M032
Suave Men 2 IN1 Scalp DefenseANTI DANDRUFF SHAMPOO AND CONDITIONERSuave Brands Co., LLC42517082-4d0a-90a3-e063-6294a90a59272026-03-26WarningsExact identifier
application number: M032
Suave Men Antidandruff 2 IN 1 Classic CleanANTI DANDRUFF SHAMPOO AND CONDITIONERSuave Brands Co., LLC425264b9-62a9-fd7b-e063-6294a90a37a22026-03-26WarningsExact identifier
application number: M032
Pyrithione ZincPYRITHIONE ZINCNice-Pak Products, LLC4db2aaf4-5caf-d9e5-e063-6294a90aa4ea2026-03-23Warnings, Adverse reactionsExact identifier
application number: M032
MG217 Psoriasis Medicated multi-symptomCOAL TARWisconsin Pharmacal Company7cb04d20-9b3c-27bb-e053-2a91aa0a5bc42026-03-20WarningsExact identifier
application number: M032
MG217 Psoriasis Therapeutic ConditionerSALICYLIC ACIDWisconsin Pharmacal Company246f239f-16fb-24b2-e054-00144ff8d46c2026-03-20WarningsExact identifier
application number: M032
Dermeleve Scalp Psoriasis TreatmentSALICYLIC ACIDAdvanced Derm Solutions LLCf55da7a8-0a26-4925-bd3b-fade6156116d2026-03-19WarningsExact 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