XtraCare Dandruff Hair Wash

Product NDC
57337-053
11-digit product format
573370053
Labeler code
57337
Product ID
57337-053_126ce8d0-8cc7-35cf-e063-6294a90a450f
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Rejoice International
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-05
Substance
SALICYLIC ACID
Active strength
10 g/325g
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 Dandruff Hair Wash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID10 g/325g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205023Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1902e6bb-e829-4b1a-b85a-1394913c77caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-053-012024-02-28C16284748780-11030e365-218a-111a-e063-dadaa90a10e2XtraCare Dandruff Hair Wash
57337-053-012024-01-30C16284748780-11030e365-218a-111a-e063-dadaa90a10e2XtraCare Dandruff Hair Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-053-01XtraCare Dandruff Hair Wash325 g in 1 BOTTLESHAMPOO3253

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)INACTIVE INGREDIENTGMR4PEN8PKXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0XTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
TRICLOSANINACTIVE INGREDIENT4NM5039Y5XXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-053XTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_1902e6bb-e829-4b1a-b85a-1394913c77ca.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 16 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicasp Anti-DandruffCOAL TARGenomma Lab USA07bc9cab-4215-4bc0-9104-e6cf85d74b682025-12-04WarningsExact identifier
application number: M032
Dermaharmony Sulfur and Salicylic AcidSALICYLIC ACID, SULFURD3 Development, Inc.8cb1d526-1ba7-6b02-e053-2a95a90aa1d02025-12-02WarningsExact identifier
application number: M032
Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.6b2de5ba-ad4b-5d43-e053-2991aa0ac3b22025-12-02WarningsExact identifier
application number: M032
Dermaharmony 1% Pyrithione ZincPYRITHIONE ZINCD3 Development, Inc.b9e765eb-f55f-f38a-e053-2a95a90aafd12025-12-02WarningsExact identifier
application number: M032
CeraVe 2 in1 Anti Dandruff Hydrating ConditionerPYRITHIONE ZINCL'Oreal USA Products Inc8a7b4626-d76b-45c4-b7a3-33c91e9a0bfe2025-12-02WarningsExact identifier
application number: M032
Head and Shoulders Apple Cider VinegarPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyb6984dab-e3da-3f36-e053-2995a90a2c0e2025-12-01WarningsExact identifier
application number: M032
DHS TARCOAL TARPerson and Covey4d088ad5-1f89-48fe-ac8a-12cb62847b382025-11-28WarningsExact identifier
application number: M032
DHS SAL 4 oz.DHS SALPerson and Covey62e13b0d-2455-46c2-bff3-1aa88b0923272025-11-28WarningsExact identifier
application number: M032
iBeaLee 5-in-1 5% Minoxidil Hair Regrowth SolutionMINOXIDILShenzhen Earth Surface Trading Co., Ltd.449fd486-69e2-2894-e063-6394a90a14212025-11-27WarningsExact identifier
application number: M032
DHS ZINCPYRITHIONE ZINCPerson and Covey39712814-4fe6-2a5b-e063-6294a90ab8cc2025-11-25WarningsExact identifier
application number: M032
Nioxin PRO CLINICAL SCALP RECOVERY purifyingPYRITHIONE ZINCWella Operations US LLC316c61e9-7cdf-a548-e063-6294a90ab7c32025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY moisturizing conditionerPYRITHIONE ZINCWella Operations US LLC31a715eb-7be8-8bad-e063-6394a90aba792025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serumPYRITHIONE ZINCThe Wella Corporation31ce9b5c-d388-8e1d-e063-6294a90a2fb82025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERYPYRITHIONE ZINCWella Operations US LLC31bf4f7f-8228-7433-e063-6394a90a2f5f2025-11-25WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCCARDINAL HEALTH 110, LLC. DBA LEADERd85f9017-6ab5-4ad6-a7f0-5570b20093cb2025-11-24WarningsExact identifier
application number: M032
Head and Shoulders Supreme Nourish and SmoothPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company8696c9d6-2306-4eb7-e053-2991aa0abd542025-11-24WarningsExact identifier
application number: M032
CeraVe Developed with Dermatologists Anti-Dandruff HydratingPYRITHIONE ZINCLOreal USA Products Inc0a64dfd9-13cc-4100-9c90-b006bac925052025-11-24WarningsExact identifier
application number: M032
FAMILY WELLNESS DRY SCALP 2 IN 1 DANDRUFF PLUS CONDITIONER Anti-DandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INC31891412-ac46-4497-a94b-558814f061fa2025-11-20WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Inc1a3bf938-fd9d-5544-e063-6294a90a9b642025-11-14WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Ince72e54ba-03fe-6748-e053-2a95a90a196f2025-11-14WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205023salicylic acid 3 % Medicated ShampooPSN1902e6bb-e829-4b1a-b85a-1394913c77ca3
205023salicylic acid 30 MG/ML Medicated ShampooSCD1902e6bb-e829-4b1a-b85a-1394913c77ca3
205023salicylic acid 3 % Medicated ShampooSY1902e6bb-e829-4b1a-b85a-1394913c77ca3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-053-0157337005301325 g in 1 BOTTLE (57337-053-01) 325 g2014-02-050000-00-00NoNoCurrent