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 28 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Anti-Dandruff Conditioner Coconut and Shea ButterPYRITHIONE ZINCRejoice International Inc.e69319c8-c49c-415b-a7ea-ec6e77fa625c2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Conditioner mint and eucalyptusPYRITHIONE ZINCRejoice International Inc.08330f44-45e2-47cb-bd2e-cef15ba61aee2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse Coconut and Shea ButterPYRITHIONE ZINCRejoice International Inc.7d9bf611-db24-4915-9b13-b7b36f47711f2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptusPYRITHIONE ZINCRejoice International Inc.b05742fe-692f-45a3-9de0-5f3f08642d782024-02-28WarningsExact identifier
application number: M032
XtraCare Dandruff Hair WashSALICYLIC ACIDRejoice International1902e6bb-e829-4b1a-b85a-1394913c77ca2024-02-28WarningsExact identifier
application number: M032
ndc (product): 57337-053
amazon basics maximum strength dandruff Anti-dandruffSELENIUM SULFIDEAMAZON.COM SERVICES LLC194e4c51-ff7b-4def-a71d-efa5dfca3efd2024-02-26WarningsExact identifier
application number: M032
Doo Gro Braids Twists Locs Dandruff Control MoisturizingSALICYLIC ACIDJ. Strickland and Co.116f4f0d-66c7-49dd-e063-6394a90ab2b52024-02-15WarningsExact identifier
application number: M032
amazon basics therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARAMAZON.COM SERVICES LLCada1be0c-53a7-443c-bc3c-f7a26b5f96a92024-02-05WarningsExact identifier
application number: M032
Equate Dry Scalp 2 in 1 Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.6440fdd9-daa8-4f15-bdee-33724993bd7b2024-02-01WarningsExact identifier
application number: M032
Equate Everyday Clean Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.4c84a67a-1f43-4f40-a172-271de7e767852024-01-29WarningsExact identifier
application number: M032
Equate Everyday Clean 2 in 1 Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.c85095f2-5dbd-4822-a83a-dc3641c4a3302024-01-29WarningsExact identifier
application number: M032
HydrocortisoneANTIPRURITIC (ANTI-ITCH)Dynarex Corporation81dff9df-6f7e-49f0-e053-2a91aa0af7e72024-01-23WarningsExact identifier
application number: M032
Walgreens Original T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWalgreen Company42cc63ab-6f79-4544-8529-7b8c36021b182024-01-22WarningsExact identifier
application number: M032
True plus Real Therapeutic T plus Plus Original Strength Tar Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARGarcoa, Inc.1f4c23d5-ca00-4387-abc7-59d9ef4719772024-01-22WarningsExact identifier
application number: M032
Walgreens Extra Strength T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWalgreen Company7f681386-976c-40f4-8b18-97413989ab782024-01-22WarningsExact identifier
application number: M032
Prosoria MedicatedSELENIUM SULFIDENuvothera, Inc.44eaaeb0-1400-4697-85d0-e8c2282c1cba2024-01-11WarningsExact identifier
application number: M032
Prosoria ScalpSALICYLIC ACIDNuvothera, Inc.52a98715-3e57-4b86-b91e-0ce433dc22bd2024-01-10WarningsExact identifier
application number: M032
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.f94f4481-c58e-4555-9863-cbaa2c4cdd072024-01-10WarningsExact identifier
application number: M032
Equate Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.408d57e4-a707-4826-a04c-99517dc9b5af2024-01-04WarningsExact identifier
application number: M032
Equate Extra Strength Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.986ac1ab-c7c3-40df-b41b-6f26cce22a432024-01-04WarningsExact 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