FDA.reportPublic FDA data

XtraCare Foam Antibacterial Hand Wash

Product NDC
57337-047
11-digit product format
573370047
Labeler code
57337
Product ID
57337-047_126d925b-6a69-87de-e063-6294a90a26bc
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Rejoice International
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-29
Substance
BENZALKONIUM CHLORIDE
Active strength
.2 g/221g
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 Foam Antibacterial Hand Wash
Brand name suffix
Vanilla Passion Flower
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.2 g/221g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1233282Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4890f81e-7994-4ea2-9412-5614c405a2a3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-047-012024-02-28C16284748780-11030e365-5881-111a-e063-dadaa90a10e2XtraCare Foam Antibacterial Hand Wash
57337-047-012024-01-30C16284748780-11030e365-5881-111a-e063-dadaa90a10e2XtraCare Foam Antibacterial Hand Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-047-01XtraCare Foam Antibacterial Hand WashVanilla Passion Flower221 g in 1 BOTTLESOAP2214

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7XTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBPXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8WXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-047XTRACARE FOAM ANTIBACTERIAL HAND WASH VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]4Current NDC, Legacy NDC, 1 package rows20240229_4890f81e-7994-4ea2-9412-5614c405a2a3.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 43 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd12585502-c043-6ffb-e063-6394a90a66022026-01-08WarningsExact identifier
application number: M003
Thompson AlcoholISOPROPYL ALCOHOLThompsonf539db3b-f309-6a60-e053-2a95a90a5a9b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d35899-8b70-14f0-e053-2995a90a5ce82026-01-08WarningsExact identifier
application number: M003
Germ AwayANTI-MICROBIAL WIPEUnico International Trading Corpa6b4eec4-0b12-3a00-e053-2a95a90a78352026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d0ce42-9076-143c-e053-2995a90aeeb62026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation261c7b8f-4adc-72ec-e063-6394a90a92112026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation144453a2-8335-77be-e063-6394a90ab6762026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d40204-3f69-7fb7-e053-2995a90a278b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIAL HAND WIPEUnico International Trading Corpad7d8546-d440-e661-e053-2a95a90a8fd32026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d47c07-12bd-3c8f-e053-2a95a90a95642026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d7f260-f5be-7940-e053-2995a90aaa032026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIALUnico International Trading Corpada02f20-07ef-9e90-e053-2995a90a0e8b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-BACTERIALUnico International Trading Corpadb59182-6541-2b35-e053-2a95a90a0f712026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Companya10f18e0-b47c-424b-847e-bcc25aa250a42026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Company5b8cff3c-71d2-418f-a43d-f570aa5408fd2026-01-08WarningsExact identifier
application number: M003
Fortinia IDPHENOLThe Podiatree Company60c88eb7-22fe-4881-e053-2a91aa0a70ce2026-01-08WarningsExact identifier
application number: M003
Gentian Violet 2%GENTIAN VIOLET 2%The Podiatree Company60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b82026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNDC, Inc.07bfadf4-7452-4c7a-b60e-feb658b92e732026-01-08WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%Epic Medical Supply Corp.0da45476-46c3-428c-a2d9-70865d2b12772026-01-08WarningsExact identifier
application number: M003
Roll On Anti Perspirant Alcohol FreeALUMINUM CHLOROHYDRATEMedline Industries, LP4f706801-dc2d-48c4-aa06-92207d86e55e2026-01-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapPSN4890f81e-7994-4ea2-9412-5614c405a2a34
1233282benzalkonium chloride 1 MG/ML Medicated Liquid SoapSCD4890f81e-7994-4ea2-9412-5614c405a2a34
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapSY4890f81e-7994-4ea2-9412-5614c405a2a34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-047-0157337004701221 g in 1 BOTTLE (57337-047-01) 221 g2014-01-290000-00-00NoNoCurrent