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
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
Refill Vanilla Passion Flower
Listing expiration
2027-12-31

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 40 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Blueberry FreesiaETHYL ALCOHOLMY IMPORTS USA LLC48f0a73a-66b5-e7d0-e063-6394a90a23332026-01-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar BlossomETHYL ALCOHOLMY IMPORTS USA LLC48f127be-8259-5aaa-e063-6294a90a3f1a2026-01-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Rose LycheeETHYL ALCOHOLMY IMPORTS USA LLC48f2433f-b924-ade1-e063-6394a90a2c9a2026-01-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pineapple SoleilETHYL ALCOHOLMY IMPORTS USA LLC48f2527c-a83e-f709-e063-6394a90aa0302026-01-21WarningsExact identifier
application number: M003
DOP Hydrogen Peroxide 3%HYDROGEN PEROXIDEOmega & Delta Co. Inc.73edab95-74ff-4f45-a941-634c83a521882026-01-21WarningsExact identifier
application number: M003
DOP Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLOmega & Delta Co., Inc.c779a35b-1118-4560-8d77-6878edb4c2672026-01-21WarningsExact identifier
application number: M003
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1b1e224c-8c00-46ea-9bdd-020a9b45321d2026-01-21WarningsExact identifier
application number: M003
CVS Hydrogen Peroxide WipesHYDROGEN PEROXIDECVS Pharmacyd2c22ab0-9647-4025-8282-6b492209b04c2026-01-20WarningsExact identifier
application number: M003
Hand Sanitizing WipesALCOHOLGerms Be Gone LLC2bd6249b-f215-7aa9-e063-6394a90a65802026-01-20WarningsExact identifier
application number: M003
SPA HAND SANITIZER SUMMER LEMONETHYL ALCOHOLRejoice International Corp.48dd563a-0558-cc76-e063-6294a90ab0412026-01-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Blueberry FreesiaETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48de4a31-c620-6c1c-e063-6394a90abb962026-01-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar BlossomETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48df981a-74da-a629-e063-6294a90a7f402026-01-20WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker FreezeALCOHOLScent Theory Products LLC48c3d5e9-2d57-5a46-e063-6394a90a07222026-01-19WarningsExact identifier
application number: M003
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487b648a-1680-6de5-e063-6394a90ab8522026-01-16WarningsExact identifier
application number: M003
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487e6851-1ca3-f9db-e063-6394a90a56f12026-01-16WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLSafetec of America, Inc.c3f0556d-f967-4f19-922c-57a2bf1848922026-01-16WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLSafetec of America3b5b46d0-308a-4649-8384-246da3a18ba12026-01-16WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLSafetec of Americabf69cc74-ebe9-40c3-a95a-a489492cc6932026-01-16WarningsExact identifier
application number: M003
NEXXGEN 50% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCd48232ab-ab55-488a-9cc1-77c8d0ba992e2026-01-16WarningsExact identifier
application number: M003
hi peach layneETHYL ALCOHOLZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD486ee2e0-2222-0574-e063-6294a90a9eff2026-01-15WarningsExact 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