FDA.reportPublic FDA data

XtraCare Foam Antibacterial Hand Wash

Product NDC
57337-045
11-digit product format
573370045
Labeler code
57337
Product ID
57337-045_126d3609-3d5c-5c9c-e063-6294a90a5439
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Rejoice International
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-24
Substance
BENZALKONIUM CHLORIDE
Active strength
.5 g/444g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Refill Vanilla Passion Flower
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.5 g/444g

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
157a14bf-f46e-49f8-96f4-a6c472eb5cb8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-045-012024-02-28C16284748780-11030e365-2756-111a-e063-dadaa90a10e2XtraCare Foam Antibacterial Hand Wash
57337-045-012024-01-30C16284748780-11030e365-2756-111a-e063-dadaa90a10e2XtraCare Foam Antibacterial Hand Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-045-01XtraCare Foam Antibacterial Hand WashRefill Vanilla Passion Flower444 g in 1 BOTTLELIQUID4443

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-045XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_157a14bf-f46e-49f8-96f4-a6c472eb5cb8.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 9 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AEROAIDBENZALKONIUM CHLORIDEAero Healthcare US LLCc9d55d86-0a4e-4c44-96e8-8d13fd16c54d2026-07-24WarningsExact identifier
application number: M003
CharmTex All in One Antibacterial Shave Gel Body WashBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltd9c9bfc61-9504-4362-8bdb-c15aa66f5a062026-07-23WarningsExact identifier
application number: M003
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltdd4d5cb95-5ee5-4006-b368-f3244fc9cd6c2026-07-23WarningsExact identifier
application number: M003
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltd8f10a193-7e01-40df-b62a-73fff5b830e32026-07-23WarningsExact identifier
application number: M003
MISTIFY WATERMELON HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574bf021-6352-e3fc-e063-6394a90ad6de2026-07-23WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, FreshBENZALKONIUM CHLORIDEQuest USA Corp5719809b-1c74-4bf3-e063-6294a90ab0082026-07-23WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINE 5%Walgreen Company262ea2c8-f571-1c0b-e063-6394a90af20b2026-07-22WarningsExact identifier
application number: M003
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.5738a502-c5ab-21b0-e063-6294a90a20a72026-07-22WarningsExact identifier
application number: M003
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
application number: M003
KeepGoing Alcohol Prep PadISOPROPYL ALCOHOLJ&A Digital Inc.5d1e776b-4027-4d05-b02f-8a2701d7bc7a2026-07-22WarningsExact identifier
application number: M003
KeepGoing Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJ&A Digital Inc.1a6303ce-8df7-4e8b-93f2-e162fdd2540c2026-07-22WarningsExact identifier
application number: M003
Lights Povidone Iodine SwabsticksPOVIDONE-IODINELights Medical Manufacture Co., Ltd.664bbf9f-650a-45fd-b9b8-d93f0ba631902026-07-22WarningsExact identifier
application number: M003
DOCTOR INKS TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd503a2db-e326-4a31-bc6a-5034ad74bf0b2026-07-21WarningsExact identifier
application number: M003
MY-SHIELD TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incc2c1f5d9-cd6e-4314-9dfc-961ed877c2932026-07-21WarningsExact identifier
application number: M003
Germ Free Topical AntisepticBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc5e004412-1797-4cbf-83e3-7001286ad1572026-07-21WarningsExact identifier
application number: M003
Midnight Magic Hand SanitizerALCOHOLScent Theory Products LLC5721d186-ec6d-fa26-e063-6294a90a76d22026-07-21WarningsExact identifier
application number: M003
McKesson PVP Prep SolutionPOVIDONE-IODINEMcKesson Medical-Surgical33fa233c-b43c-42d8-af37-a58f098a0d512026-07-21WarningsExact identifier
application number: M003
Twisted Caramel Apple Hand SanitizerALCOHOLScent Theory Products LLC572a82e3-93ec-9af4-e063-6294a90a9c262026-07-21WarningsExact identifier
application number: M003
Molten Marshmallow Hand SanitizerALCOHOLScent Theory Products LLC572aa67e-52f7-b424-e063-6394a90ac4ae2026-07-21WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITYBENZALKONIUM CHLORIDEQuest USA Corp57135b3f-884d-1a03-e063-6294a90ae3e92026-07-20WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapPSN157a14bf-f46e-49f8-96f4-a6c472eb5cb83
1233282benzalkonium chloride 1 MG/ML Medicated Liquid SoapSCD157a14bf-f46e-49f8-96f4-a6c472eb5cb83
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapSY157a14bf-f46e-49f8-96f4-a6c472eb5cb83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-045-0157337004501444 g in 1 BOTTLE (57337-045-01) 444 g2014-01-240000-00-00NoNoCurrent