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
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 Anti-Dandruff Conditioner
Brand name suffix
Coconut and Shea Butter
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC20 mg/400mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R953O2RHZ5Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e69319c8-c49c-415b-a7ea-ec6e77fa625cAvailable on FDA.report

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

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 13 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Bare Minimal IngredientsPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company003c585f-9fda-c86e-e063-6394a90ae3772025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Dual Pack Smooth and SilkyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company19ad72ea-9a4b-0a35-e063-6394a90a91312025-12-31WarningsExact identifier
application number: M032
Head and Shoulders 2in1 MEN Citrus and CedarPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company20d361ff-4a53-c1d4-e063-6294a90a24be2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Aloe Vera Soothing Relief DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company27ebc90d-7171-ccac-e063-6394a90a1c172025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Aloe Vera Soothing Relief 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company27ec4d49-a783-cacd-e063-6394a90adbbe2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Moisturizing Avocado Oil 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company27eca9a6-1dc0-b18a-e063-6394a90a1f412025-12-31WarningsExact identifier
application number: M032
Aloe Coal by T SpruillPYRITHIONE ZINCT. Spruill LLC.31212e41-bb2d-4baa-e063-6294a90a8d322025-12-29WarningsExact identifier
application number: M032
DHS Body WashZINC PYRITHIONEPerson and Covey469f38ac-6a5f-9954-e063-6294a90a99e02025-12-23WarningsExact identifier
application number: M032
Quality Choice PsoriasisSALICYLIC ACIDChain Drug Marketing Association, Inc.469ffccf-f5d7-a6e0-e063-6294a90ab4532025-12-23WarningsExact identifier
application number: M032
Quality Choice TherapeuticSALICYLIC ACIDChain Drug Marketing Association, Inc.46a009be-936d-ceb0-e063-6294a90a48512025-12-23WarningsExact identifier
application number: M032
Nizoral PsoriasisSALICYLIC ACIDKramer Laboratories6ad7f931-5411-474b-a86e-b511811b7dc02025-12-23WarningsExact identifier
application number: M032
Nizoral Psoriasis ReliefSALICYLIC ACIDKramer Laboratories3f8bc77e-a5cf-469c-9733-22d3de33ef5a2025-12-23WarningsExact identifier
application number: M032
X20HAIR ANTI FUNGALFOLLICULITISSHAMPOOZINC PYRITHIONEGuangzhou Tata Biotechnology Co., Ltd.358c0dc3-2778-8aff-e063-6394a90a877c2025-12-22WarningsExact identifier
application number: M032
NTG T/Sal 3% Salicylic Acid Anti-Dandruff for Scalp Build Up ControlSALICYLIC ACIDKenvue Brands LLC3c11da1d-0b24-743a-e063-6394a90a06992025-12-22WarningsExact identifier
application number: M032
Neutrogena T/Sal Plus 3% Salicylic Acid Anti-Dandruff for Dry, Itchy Scalp ControlSALICYLIC ACIDKenvue Brands LLC3c149239-107b-238d-e063-6294a90ac1622025-12-22WarningsExact identifier
application number: M032
Quality Choice PsoriasisSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd4651cabb-98ee-a257-e063-6294a90afd3b2025-12-19WarningsExact identifier
application number: M032
Quality Choice TherapeuticSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd465215fc-3648-152c-e063-6294a90ad4882025-12-19WarningsExact identifier
application number: M032
RoyceDerm Tea Tree TherapeuticSALICYLIC ACID 3%RoyceDerm LLC46542754-2256-a23c-e063-6394a90a77952025-12-19WarningsExact identifier
application number: M032
Psoriasin In-Shower TreatmentCOAL TARKobayashi Healthcare International, Inc.bca8d3d7-5463-0bf9-e053-2a95a90a4e732025-12-19WarningsExact identifier
application number: M032
Head and Shoulders Green ApplePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companya296e74c-bc52-4406-a161-aff935288cd42025-12-18WarningsExact identifier
application number: M032

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