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 27 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Groot Anti-dandruff Scalp CareSALICYLIC ACIDTAI GUK PHARM. CO., LTD1e572a86-9115-4597-e063-6394a90a484e2024-05-31WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1SALICYLIC ACIDTAI GUK PHARM. CO., LTD1e572a97-1a38-8360-e063-6394a90a47a32024-05-31WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp CareSALICYLIC ACIDLG H&H CO., LTD.1e584724-7059-38ab-e063-6394a90aceb72024-05-31WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1SALICYLIC ACIDLG H&H CO., LTD.1e584724-705a-38ab-e063-6394a90aceb72024-05-31WarningsExact identifier
application number: M032
Thera-GelCOAL TARMajor Pharmaceuticals1c18fde9-d39b-4339-8f62-3f352d4502912024-05-28WarningsExact identifier
application number: M032
upandup Anti-dandruff with Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDTARGET CORPORATION482332f8-0db4-4ec7-81e9-c4efbba16a262024-05-20WarningsExact identifier
application number: M032
True Plus Real Therapeutic T PLUS EXTRA STRENGTH COAL TAR TAR DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARGarcoa, Inc.20116e1e-56f1-4018-99ef-758de7fc24642024-05-10WarningsExact identifier
application number: M032
up and up Moisturizing Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDETARGET CORPORATIONe315b2d8-304d-4807-9594-9286e9b642ef2024-05-10WarningsExact identifier
application number: M032
amazon basics therapeutic tar gel anti-dandruff Extra Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARAMAZON.COM SERVICES LLC0464b4ff-1be1-4d84-b7fd-b771ebc1e16c2024-05-09WarningsExact identifier
application number: M032
Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitisSELENIUM SULFIDEWalgreen Companycc83427d-49e6-4a20-9d03-9ec8ce27e4872024-05-09WarningsExact identifier
application number: M032
meijer MEDICATED selenium sulfide Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDEMeijer Distribution, Incc8dee061-3362-400f-aa59-93ec0b8125ba2024-05-01WarningsExact identifier
application number: M032
Walgreens Dandruff With Menthol/Selenium Sulfide Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDEWalgreen Company70c7b400-a295-4b99-8673-e6a38343d76f2024-05-01WarningsExact identifier
application number: M032
up and up Medicated Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDETARGET CORPORATIONa516282f-ed6b-4e94-b269-ea34f700dd692024-04-25WarningsExact identifier
application number: M032
Walgreens Tplus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDWalgreen Company339d390e-0b09-4c42-af1f-9465daa9f7c92024-04-22WarningsExact identifier
application number: M032
Walgreens Everyday Clean Dandruff Anti-DandruffPYRITHIONE ZINCWalgreen Company930d92a9-d0bc-42e1-873e-5c27e93a39b52024-04-22WarningsExact identifier
application number: M032
Rugby Anti-DandruffSELENIUM SULFIDERugby Laboratoriesf8942f2b-32fb-4a2d-b0cf-0f2d1c6974c22024-03-14WarningsExact identifier
application number: M032
Leader Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-DandruffSELENIUM SULFIDECardinal Health, 110 dba LEADER3f64a2ef-a415-49b0-bf14-eb4da66d511f2024-03-13WarningsExact identifier
application number: M032
Leader Therapeutic Dandruff Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasisSALICYLIC ACIDCardinal Health, 110 dba LEADER509434a9-50c4-4337-8e5b-17bdc667d23b2024-03-13WarningsExact identifier
application number: M032
meijer therapeutic t plus plus tar gel dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARMeijer Distribution, Incf7cce683-6e1f-4214-a38b-37eb046b7f4d2024-03-05WarningsExact identifier
application number: M032
Sebex Antidandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACID, SULFURRugby Laboratoriesaec81d61-1d28-490f-9654-f66bd4a30ffa2024-03-01WarningsExact 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