XtraCare Anti-Dandruff Conditioner

Product NDC
57337-025
11-digit product format
573370025
Labeler code
57337
Product ID
57337-025_126c4eff-f538-0419-e063-6294a90a752f
Type
HUMAN OTC DRUG
Nonproprietary name
PYRITHIONE ZINC
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
Rejoice International Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-10-09
Substance
PYRITHIONE ZINC
Active strength
20 mg/400mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XtraCare Anti-Dandruff Conditioner
Brand name suffix
Coconut and Shea Butter
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC20 mg/400mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR953O2RHZ5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-025-012024-02-28C16284748780-11030e365-6ca0-111a-e063-dadaa90a10e2XtraCare Anti-Dandruff Conditioner
57337-025-012024-01-30C16284748780-11030e365-6ca0-111a-e063-dadaa90a10e2XtraCare Anti-Dandruff Conditioner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-025-01XtraCare Anti-Dandruff ConditionerCoconut and Shea Butter400 mg in 1 BOTTLELOTION/SHAMPOO4003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5XTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5XTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
C13-16 ISOPARAFFININACTIVE INGREDIENTLED42LZG6OXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBPXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
COCOS NUCIFERA WHOLEINACTIVE INGREDIENT245J88W96LXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
POLYQUATERNIUM-37 (3000 MPA.S)INACTIVE INGREDIENTHU373G0YSUXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
TRIDECETH-6INACTIVE INGREDIENT3T5PCR2H0CXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-025XTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]3Current NDC, Legacy NDC, 1 package rows20240229_e69319c8-c49c-415b-a7ea-ec6e77fa625c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-025-0157337002501400 mg in 1 BOTTLE (57337-025-01) 400 mg2013-10-090000-00-00NoNoCurrent