FDA.reportPublic FDA data

XtraCare Anti-Dandruff Conditioner

Product NDC
57337-027
11-digit product format
573370027
Labeler code
57337
Product ID
57337-027_126c756d-69d3-085d-e063-6294a90ae640
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
mint and eucalyptus
Listing expiration
2026-12-31

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
08330f44-45e2-47cb-bd2e-cef15ba61aeeAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-027-012024-02-28C16284748780-11030e365-0e3c-111a-e063-dadaa90a10e2XtraCare Anti-Dandruff Conditioner
57337-027-012024-01-30C16284748780-11030e365-0e3c-111a-e063-dadaa90a10e2XtraCare Anti-Dandruff Conditioner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-027-01XtraCare Anti-Dandruff Conditionermint and eucalyptus400 mg in 1 BOTTLELOTION/SHAMPOO4003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5XTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5XTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
C13-16 ISOPARAFFININACTIVE INGREDIENTLED42LZG6OXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBPXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
COCOS NUCIFERA WHOLEINACTIVE INGREDIENT245J88W96LXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
POLYQUATERNIUM-37 (3000 MPA.S)INACTIVE INGREDIENTHU373G0YSUXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
TRIDECETH-6INACTIVE INGREDIENT3T5PCR2H0CXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-027XTRACARE ANTI-DANDRUFF CONDITIONER MINT AND EUCALYPTUS (PYRITHIONE ZINC) LOTION/SHAMPOO [REJOICE INTERNATIONAL INC.]3Current NDC, Legacy NDC, 1 package rows20240229_08330f44-45e2-47cb-bd2e-cef15ba61aee.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 1 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SMOOTH AND SOFT DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC9e235139-07a2-469a-8601-db69379ce3472026-08-24WarningsExact identifier
application number: M032
ITCHY SCALP RELIEF DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC634019c2-03a3-4fed-939e-6f9a50ddea7b2026-08-24WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b4f9e3-c241-6a70-e063-6294a90a364f2026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b52a52-dab0-87b5-e063-6294a90a05962026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b67ce0-3546-c18a-e063-6394a90ae50a2026-08-23WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.599f2cce-0c27-d425-e063-6394a90a15652026-08-22WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.59a0a062-92d1-210a-e063-6394a90a9bf92026-08-22WarningsExact identifier
application number: M032
Ouai Anti-DandruffSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5990c45f-f653-b403-e063-6394a90a329d2026-08-21WarningsExact identifier
application number: M032
Dermatology Psoriasis CreamCOAL TARG.M.J Natural Products, Inc.96cc5455-f3b8-4ded-a158-5de209d7bf0d2026-08-21WarningsExact identifier
application number: M032
apgwgzminoxidil5%MINOXIDILGuangdong Jiaoyu Biotechnology Co., Ltd596d0b43-5cb1-be25-e063-6394a90abbed2026-08-19WarningsExact identifier
application number: M032
TEA TREE Oil DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC280391ce-ccd9-4b39-95a2-93e7fca84ccc2026-08-18WarningsExact identifier
application number: M032
apgwgzminoxidil2%MINOXIDILGuangdong Jiaoyu Biotechnology Co., Ltd5957c990-e274-6278-e063-6394a90af2b72026-08-18WarningsExact identifier
application number: M032
EVERYDAY CLEAN DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC3983b688-28ae-462e-8686-6cf2f2c1cca42026-08-18WarningsExact identifier
application number: M032
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.378311aa-95f7-4c69-bc00-e688468262bd2026-08-18WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC496e178b-e29b-071e-e063-6394a90aa0182026-08-13WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis shampoo.SALICYLIC ACID 3%RoyceDerm LLC4995ce33-e231-8f86-e063-6394a90af4862026-08-13WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast ReliefPYRITHIONE ZINCRida LLCd1e4dee7-5962-4ec1-ab99-9d547077b2f22026-08-05WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief TreatmentSALICYLIC ACIDRida LLC6226ce12-432f-402e-bda7-a5ca96f0b8382026-08-05WarningsExact identifier
application number: M032
JOHNSON FOAMMINOXIDILJOHNSON BIOPHARMACEUTICAL INC.1d44a75c-c940-680c-e063-6394a90a58392026-08-02WarningsExact identifier
application number: M032
FOLKI COSMETIC Psoriasis CreamSALICYLIC ACID 3% PSORIASIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.575786e0-21b8-ad9d-e063-6394a90ad0d42026-07-24WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-027-0157337002701400 mg in 1 BOTTLE (57337-027-01) 400 mg2013-10-090000-00-00NoNoCurrent