FDA.reportPublic FDA data

XtraCare Foam Antibacterial Hand Wash

Product NDC
57337-048
11-digit product format
573370048
Labeler code
57337
Product ID
57337-048_126d94b4-b160-86c0-e063-6294a90a0347
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
Wild Berry Blast
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
5c109f7c-1f4d-484a-b6ea-3bbcf572bbacAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-048-012024-02-28C16284748780-11030e365-14b0-111a-e063-dadaa90a10e2XtraCare Foam Antibacterial Hand Wash
57337-048-012024-01-30C16284748780-11030e365-14b0-111a-e063-dadaa90a10e2XtraCare Foam Antibacterial Hand Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-048-01XtraCare Foam Antibacterial Hand WashWild Berry Blast221 g in 1 BOTTLESOAP2214

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-048XTRACARE FOAM ANTIBACTERIAL HAND WASH WILD BERRY BLAST (BENZALKONIUM CHLORIDE) SOAP [REJOICE INTERNATIONAL]4Current NDC, Legacy NDC, 1 package rows20240229_5c109f7c-1f4d-484a-b6ea-3bbcf572bbac.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 53 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCcef2d3d4-bd5f-4f2a-bb2d-5292b78501c12025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC90d6fe21-7b41-4429-8c03-4d35e66a3b292025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC87aaabb6-d121-464f-993d-5182de13d49e2025-11-28WarningsExact identifier
application number: M003
FF SILICONE SPRY SANI PPKFF SILICONE SPRY SANI PPKZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD4493c534-187e-f680-e063-6294a90aacdb2025-11-27WarningsExact identifier
application number: M003
Walgreen Maximum strength pain relieving cleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWALGREENS CO.9a0443a2-f1a9-482d-b5ee-abe983e4ae322025-11-26WarningsExact identifier
application number: M003
WalgreensFIRST AID ANTISEPTICWalgreensae731d28-8530-4dd0-aef7-b25f784b47772025-11-26WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.44677bab-41ea-3392-e063-6394a90a61872025-11-25WarningsExact identifier
application number: M003
Antibacterial Hand Sanitizer Spray.ALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c242e55-4585-9f07-e063-6294a90a6fb42025-11-25WarningsExact identifier
application number: M003
ORANGE HAND SANITIZER aloe and vitamin EALCOHOLGanzhou Olivee Cosmetic Co., Ltd.a9c1e4f6-e354-4624-a902-8c9154ea47232025-11-25WarningsExact identifier
application number: M003
COCONUT HAND SANITIZER aloe and vitamin EALCOHOLGanzhou Olivee Cosmetic Co., Ltd.40d7fb84-4b39-440d-a590-8aaf8ec312d72025-11-25WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESGuangzhou Baihua Co., Ltd4453997f-b885-ad2d-e063-6294a90a2c8e2025-11-24WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEVALU MERCHANDISERS, COc79540fe-b972-41a4-a215-e21e30b903d12025-11-24WarningsExact identifier
application number: M003
Lights SwabsticksISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4435a4e6-46ae-f49b-e063-6394a90a1d9e2025-11-22WarningsExact identifier
application number: M003
FloraMedis Hand SanitizerHAND SANITIZERSichuan Pengtai Qifan Technology Co., Ltd4415ca9f-10b1-88f7-e063-6294a90a2e092025-11-21WarningsExact identifier
application number: M003
AMERIDERMBZKSHIELD LINE LLC440b711a-de12-2d28-e063-6394a90ae42a2025-11-20WarningsExact identifier
application number: M003
Recens FoamALCOHOLCertus Medical, Inc.ea384dfc-c894-3124-e053-2a95a90a81c22025-11-20WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer (Peach Peony, Dragonfruit Paradise, Coastal Fleur)ALCOHOLScent Theory Products LLC440f0a52-de0a-8f44-e063-6294a90a18b52025-11-20WarningsExact identifier
application number: M003
MK Alcohol Prep Pads LargeISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltdf1ff70d7-d0f2-45db-96e9-883b54c6e4412025-11-20WarningsExact identifier
application number: M003
Aero Care Handy Quat Antiseptic HandwashBENZALKONIUM CHLORIDEABC Compounding Co., Inc.ab015f59-160a-47d1-8d2f-fbe1b23177b32025-11-19WarningsExact identifier
application number: M003
FastALCOHOLABC Compounding Co., Inc.4f958247-5370-4250-b2eb-39faa97199392025-11-19WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapPSN5c109f7c-1f4d-484a-b6ea-3bbcf572bbac4
1233282benzalkonium chloride 1 MG/ML Medicated Liquid SoapSCD5c109f7c-1f4d-484a-b6ea-3bbcf572bbac4
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapSY5c109f7c-1f4d-484a-b6ea-3bbcf572bbac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-048-0157337004801221 g in 1 BOTTLE (57337-048-01) 221 g2014-01-290000-00-00NoNoCurrent