FDA.reportPublic FDA data

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 3 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antifungal Psoriasis Shampoo.SALICYLIC ACID 2%Trovina Co. Ltd5512ac82-e3c5-37e6-e063-6294a90a92d62026-07-01WarningsExact identifier
application number: M032
Anti-fungalANTI-FUNGAL SHAMPOOShenzhen Chaoxiji Technology Co.,Ltd.555cb4fa-6f59-fa69-e063-6394a90a1db62026-06-28WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC55246263-7345-ba65-e063-6294a90ab1632026-06-26WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc552926da-0dfb-4248-e063-6294a90ab4a82026-06-26WarningsExact identifier
application number: M032
Dermoia Seborrheic Dermatitis Selenium SulfideSELENIUM SULFIDETREASUREWISE LLC04b8532e-44a7-4eaf-a46d-87611ec93c242026-06-23WarningsExact identifier
application number: M032
Dermgentle Seborrheic Scalp SerumPYRITHIONE ZINCDermgentle LLC54a0901a-404f-ea0e-e063-6294a90a6dc72026-06-19WarningsExact identifier
application number: M032
Silvagle Selenium Sulfide Anti DandruffShampooSELENIUM SULFIDEGUANGZHOU BAOSIJIE BIOTECHNOLOGY CO., LTD54885ae3-7e2f-7bd2-e063-6394a90a97fe2026-06-18WarningsExact identifier
application number: M032
Pharmlitalia Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd845a82f6-7d0e-416d-b5b0-bf788dca2f542026-06-18WarningsExact identifier
application number: M032
anti dandruff SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD5459e831-41e7-f1c7-e063-6394a90ae0982026-06-16WarningsExact identifier
application number: M032
ANTI DANDRUFF SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD545780f9-a202-95e9-e063-6394a90a982f2026-06-15WarningsExact identifier
application number: M032
Swiftalyn Antifungal Scalp Shampoo.SALICYLIC ACID 2%GENUINE INNOVATION LTD53f84e9f-ecc1-dfc2-e063-6394a90af2432026-06-11WarningsExact identifier
application number: M032
Anti-DandruffZINC PYRITHIONEMEERAY COSMETICS CO., LTD.f5b2d9f2-ff29-2da1-e053-2995a90a68f32026-06-08WarningsExact identifier
application number: M032
Psoriasin Deep MoisturizingCOAL TARKobayashi Healthcare International, Inc.8bb4a84f-dd80-cbbc-e053-2a95a90a04752026-06-08WarningsExact identifier
application number: M032
Head and Shoulders Hutchs Cooling RushPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5383143a-f930-46f8-e063-6294a90a3a752026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Double Coverage 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53835f68-44d8-b1af-e063-6294a90acae92026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Polamalu s Hall of Fame HairPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53839833-d1c2-fa3b-e063-6394a90a6bd92026-06-05WarningsExact identifier
application number: M032
RENUEVO ANTI-DAMDRUFFZINC PYRITHIONELEON UP GLOBAL HOLDING CORP5387b840-ad0a-4c20-e063-6294a90a59e32026-06-05WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Dandruff Medicated Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Health307e4b16-10ab-44f4-86b9-709d10566d4c2026-06-04WarningsExact identifier
application number: M032
Minoxidil Hair Growth SerumMINOXIDILShenzhen Deshijian Medical Equipment Co., Ltd535cdf78-90bc-86b4-e063-6294a90a2c202026-06-04WarningsExact identifier
application number: M032
Dermaharmony Unscented BarSALICYLIC ACIDD3 Development, Inc.52f5885f-2a40-c3f5-e063-6294a90a434e2026-05-29WarningsExact 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