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 9 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DandruffPYRITHIONE ZINC 1%Meijer, Inc.28525947-97f6-4b3f-b8bd-596ffcf611882026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Dry ScalpPYRITHIONS ZINCMeijer, Inc.57a944af-397f-41d9-bfe0-7cac0dd26cb12026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCMeijer, Inc.9ca4dd70-3dca-4d5a-a13d-51a5dbf92af02026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders Hydrating Coconut KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b33d7cd-93ae-6ec9-e063-6294a90afc632026-02-19WarningsExact identifier
application number: M032
DandruffSELENIUM SULFIDEMeijer, Inc.c0e4f8cb-74fc-4c0d-9721-f87aa2aa19922026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Selsun Blue Naturals Itchy, Dry ScalpSALICYLIC ACIDChattem, Inc.ed031a0f-7467-4b2c-a6b6-95306f6ee8282026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Hydrating Coconut 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b1a4f24-ff9b-9677-e063-6294a90a9c222026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Coconut 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7cc1c6c8-27cd-6d9e-e053-2991aa0a99df2026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Tea Tree Oil 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company96b37f23-230f-0652-e053-2a95a90a1f642026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Sensitive Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company38921198-56d3-ab01-e063-6394a90a89b92026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Smooth and Silky 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb592026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Hydrating CoconutPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b20caa0-9ec6-3bfc-e063-6294a90ac68e2026-02-18WarningsExact identifier
application number: M032
Selsun Blue 2-in-1SELENIUM SULFIDEChattem, Inc.f97e458c-cce3-498f-81fc-1b96a4e8f50a2026-02-18WarningsExact identifier
application number: M032
Selsun Blue Itchy Dry ScalpPYRITHIONE ZINCChattem, Inc.c491014d-f8c7-46bb-b065-eaf5ea8428602026-02-18WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFI77b2e0da-a6d7-42b5-92af-4e7979817b782026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFI064ff929-d965-4b1a-98a9-f2779f346d7f2026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFId7c4507e-7f74-4bcd-9b0e-0b097193a1a82026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFIecc20b71-eb6b-43ed-86bc-32d61641ee3a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCTKC Holdings, Inc.c3bc9a89-b1f3-4b7a-bebb-00c341956d602026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCValu Merchandisers Companybb0a74e0-2312-4444-b7e1-19a9a3a7007e2026-02-16Warnings, Adverse reactionsExact 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