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 21 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Scalp Therapy Anti-Dandruff Extra StrengthSALICYLIC ACIDKenvue Brands LLCca49fd70-f0d3-3375-e053-2a95a90af8352025-03-10WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Coastal TidePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company20d3208c-d22b-84f1-e063-6394a90ab6102025-03-06WarningsExact identifier
application number: M032
Head and Shoulders Supreme Nourish and Smooth ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86abb2ee-6b35-32eb-e053-2a91aa0a8bc62025-03-03WarningsExact identifier
application number: M032
Cantu Guava Ginger Anti DandruffSALICYLIC ACIDPDC Brandsd43a540b-bea5-2055-e053-2995a90a25fb2025-03-03WarningsExact identifier
application number: M032
Head and Shoulders 2in1 MenTimber Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2d7ff3d8-d142-9537-e063-6294a90ab02c2025-02-06WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Clinical Strength Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company2d041983-5750-e0f1-e063-6394a90a5b9e2025-01-31WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Vanilla and AmberPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cf441e0-3ddd-0f9e-e063-6394a90a092c2025-01-30WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Advanced Series Full and ThickPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7d3f0664-a9e7-6b63-e053-2991aa0a4b0a2025-01-29WarningsExact identifier
application number: M032
Head and Shoulders Dry Scalp Care Dual PackPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cdb1e94-3923-84f7-e063-6394a90a07d52025-01-29WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Itchy Scalp ReliefPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cc7724c-a1f1-a42d-e063-6394a90a83cf2025-01-28WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Advanced Series Swagger Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7d3cca83-f99e-2c30-e053-2991aa0a4c9d2025-01-28WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Advanced Oil ControlSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company2ccaceed-9928-ef05-e063-6394a90a65112025-01-28WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Soothing HydrationPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company003d1723-1fd9-ef2b-e063-6294a90aafda2025-01-28WarningsExact identifier
application number: M032
QC Anti Dandruff T PlusCOAL TARGuangzhou Danting Bath&Body Care Industry Co. Ltd.2c7630ab-b7fa-462c-e063-6394a90a30bb2025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff 2 in 1PYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd2c762c86-ba7a-1976-e063-6394a90a49f22025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Dry Scalp CarePYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c764242-df65-7383-e063-6394a90a34b02025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Everyday CleanPYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c767d79-6ffe-ebaa-e063-6394a90a39d12025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Everyday CleanPYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd2c77edae-be2b-3a37-e063-6294a90a001d2025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Dry Scalp CarePYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd.2c77e4b6-5a65-c7ea-e063-6394a90a6abb2025-01-24WarningsExact identifier
application number: M032
Zincon Medicated Anti-DandruffPYRITHIONE ZINCNeoteric Cosmetics, Inc.2c26bd1e-35d4-f1a2-e063-6294a90af5762025-01-23WarningsExact 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