XtraCare Antibacterial Hand Cleanse

Product NDC
57337-069
11-digit product format
573370069
Labeler code
57337
Product ID
57337-069_2decfde9-cfb3-3dbb-e063-6294a90aac46
Type
HUMAN OTC DRUG
Nonproprietary name
Triclosan
Dosage form
SOAP
Route
TOPICAL
Labeler
Rejoice International, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-03
Substance
TRICLOSAN
Active strength
3.3 mg/221mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57337-069-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57337-069-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-069-010efc9e666f02…f202fb6c5f17…

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 Antibacterial Hand Cleanse
Brand name suffix
Fresh Citrus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRICLOSAN3.3 mg/221mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NM5039Y5XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020118Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e87ef6e6-ef41-43c4-bfdf-b7e3446436b7Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-069-012025-02-12C16284748780-12cef2736-a759-d83d-e063-dadaa90ab31fXtraCare Antibacterial Hand Cleanse
57337-069-012025-01-30C16284748780-12cef2736-a759-d83d-e063-dadaa90ab31fXtraCare Antibacterial Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-069-01XtraCare Antibacterial Hand CleanseFresh Citrus221 mL in 1 BOTTLESOAP2213

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
TRICLOSANACTIVE MOIETY4NM5039Y5XXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-069XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20250214_e87ef6e6-ef41-43c4-bfdf-b7e3446436b7.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 2 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WalmartISOPROPYL ALCOHOLWalmart, Inc.2eff98ba-5736-b07e-e063-6394a90aeea92026-09-04WarningsExact identifier
application number: M003
Walgreen AlcoholISOPROPYL ALCOHOLWalgreens Companydeeae1ea-3d81-4260-95be-c4f328e3fdef2026-09-04WarningsExact identifier
application number: M003
Dollar GeneralISOPROPYL ALCOHOLDollar General Corporation00b2ef34-42d9-523c-e063-6294a90a753d2026-09-03WarningsExact identifier
application number: M003
Signature Select Alcohol Prep PadsISOPROPYL ALCOHOLBetter Living Brands LLC31ce72e3-03a3-1608-e063-6394a90ad8502026-09-03WarningsExact identifier
application number: M003
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEKroger Co.fe604470-917f-4cbd-a1e6-ac1dc7c57ff62026-09-02WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLRite Aid Corporation5104f9ab-0b28-449f-a55a-5438713a24df2026-09-02WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUpLift Brands, LLC5a81b635-d188-0b29-e063-6294a90a1e4b2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDECVS Pharmacy, Inc.7f518646-c8fe-499a-b5e4-8e5a5a90e01d2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLThe Kroger Company6551187f-5cde-4149-931f-b057bd7607502026-09-02WarningsExact identifier
application number: M003
Unscented NasalGuard Antiseptic TopicalBENZALKONIUM CHLORIDETRUTEK CORP.eb036e11-a28c-fdc0-e053-2a95a90a9cdb2026-09-02WarningsExact identifier
application number: M003
Harris TeeterISOPROPYL ALCOHOLHarris Teeter, LLCd2bb20bd-ec83-8d80-e053-2a95a90a2bba2026-09-02WarningsExact identifier
application number: M003
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-09-02WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLTopco Associates2642298f-607e-fdca-e063-6394a90a69d92026-09-02WarningsExact identifier
application number: M003
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
application number: M003
NasalGuard Antiseptic Topical Cool MentholBENZALKONIUM CHLORIDETRUTEK CORP.e9fd3ef8-78ff-6c9f-e053-2a95a90a21a82026-09-01WarningsExact identifier
application number: M003
Maximum Strength Betadine ClearBENZALKONIUM CL AND PRAMOXINE HCLAtlantis Consumer Healthcare, Inc.31b94a76-1536-47c0-ab03-e487c2625c582026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a28101f-ea8e-6071-e063-6294a90aad912026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a3e62ce-52dc-121b-e063-6294a90a898f2026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a49db18-c270-6f46-e063-6294a90afb5d2026-08-31WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020118triclosan 0.15 % Medicated Liquid SoapPSNe87ef6e6-ef41-43c4-bfdf-b7e3446436b73
1020118triclosan 1.5 MG/ML Medicated Liquid SoapSCDe87ef6e6-ef41-43c4-bfdf-b7e3446436b73
1020118triclosan 0.15 % Medicated Liquid SoapSYe87ef6e6-ef41-43c4-bfdf-b7e3446436b73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-069-0157337006901221 mL in 1 BOTTLE (57337-069-01) 221 ml2013-09-030000-00-00NoNoCurrent