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
Ingredient	Strength
BENZALKONIUM CHLORIDE	.5 g/444g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
157a14bf-f46e-49f8-96f4-a6c472eb5cb8	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-045-01	2024-02-28	C162847	48780-1	1030e365-2756-111a-e063-dadaa90a10e2	XtraCare Foam Antibacterial Hand Wash
57337-045-01	2024-01-30	C162847	48780-1	1030e365-2756-111a-e063-dadaa90a10e2	XtraCare Foam Antibacterial Hand Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-045-01	XtraCare Foam Antibacterial Hand WashRefill Vanilla Passion Flower	444 g in 1 BOTTLE	LIQUID	444		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
CETRIMONIUM CHLORIDE	INACTIVE INGREDIENT	UC9PE95IBP	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
LAURAMINE OXIDE	INACTIVE INGREDIENT	4F6FC4MI8W	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-045	XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL VANILLA PASSION FLOWER (BENZALKONIUM CHLORIDE) LIQUID [REJOICE INTERNATIONAL]	3	Current NDC, Legacy NDC, 1 package rows	20240229_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 109 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ethyl Rubbing Alcohol 70 Percent	ETHYL ALCOHOL	Pharma Nobis, LLC	e42fccc2-1b50-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M003
Isopropyl Alcohol 70 Percent With Wintergreen Oil	ISOPROPYL ALCOHOL	Pharma Nobis, LLC	e42f6c6d-c4e1-02c6-e053-2995a90a3ace	2023-12-26	Warnings	Exact identifier application number: M003
CVS Merthiolate	BENZALKONIUM CHLORIDE	CVS Pharmacy	dd498ab1-8350-41aa-86fc-2db57005f3e2	2023-12-22	Warnings	Exact identifier application number: M003
Povidone Iodine	POVIDONE IODINE 10%	Pharma Nobis, LLC	e42eee1b-3539-fb17-e053-2995a90af61d	2023-12-22	Warnings	Exact identifier application number: M003
Decolorized Iodine	ETHYL ALCOHOL	Pharma Nobis, LLC	e21dd43b-3712-cb16-e053-2a95a90ac276	2023-12-22	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol 70 Percent	ISOPROPYL ALCOHOL	Pharma Nobis, LLC	e42f727c-beb0-fe9d-e053-2995a90aafea	2023-12-22	Warnings	Exact identifier application number: M003
Povidone Iodine	POVIDONE IODINE GARGLE 0.5%	Pharma Nobis, LLC	e42ee827-b350-7b56-e053-2a95a90a69cf	2023-12-22	Warnings	Exact identifier application number: M003
Merthiolate	BENZALKONIUM CHLORIDE	Pharma Nobis, LLC	e42f727c-beaf-fe9d-e053-2995a90aafea	2023-12-22	Warnings	Exact identifier application number: M003
Isopropyl Alcohol 91 Percent	ISOPROPYL ALCOHOL	Pharma Nobis, LLC	e42f6c6d-c4e0-02c6-e053-2995a90a3ace	2023-12-22	Warnings	Exact identifier application number: M003
RevitaDERM Wound Care	BENZALKONIUM CHLORIDE	Blaine Labs Inc.	9254dada-4e32-43a0-892b-c488d68e23e7	2023-12-21	Warnings	Exact identifier application number: M003
NUMSTAT Antiseptic and Pain Relieving Prep Pad	ALCOHOL, MENTHOL, AND BENZOCAINE PREP PAD	Spectra Medical Devices, LLC	07d20040-9dd9-0aba-e063-6294a90ab7cf	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Iodides	ALCOHOL	Strategic Sourcing Services LLC	8d9f2112-c678-4559-b567-9d6d287c5fa3	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Strategic Sourcing Services LLC	72eeb3e6-c0a1-4b18-87f1-8db06f9bd111	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Strategic Sourcing Services LLC	cbe02fa1-c167-4b77-8f63-817362090e19	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Isopropyl Alcohol 91 Percent	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	fbd2aa69-b1c7-4a28-9642-a436ae09faaf	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Povidone Iodine	POVIDONE IODINE 10%	Chain Drug Market Association	9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Chain Drug Market Association	55c970ed-13a9-4ea2-a8cb-aaf14d3a214d	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Iodides Tincture	ETHYL ALCOHOL	Chain Drug Market Association	71aedfd5-e81f-4b69-b163-527ff1ce30b1	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Merthiolate	BENZALKONIUM CHLORIDE	Chain Drug Market Association	5b7303b9-b8c4-4e7c-876f-70ed76443055	2023-12-20	Warnings	Exact identifier application number: M003
Premier Value Povidone Iodine	POVIDONE IODINE 10%	Chain Drug Consortium	5cc9d782-5f7e-27d9-e053-2991aa0a2428	2023-12-20	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1233282	benzalkonium chloride 0.1 % Medicated Liquid Soap	PSN	157a14bf-f46e-49f8-96f4-a6c472eb5cb8	3
1233282	benzalkonium chloride 1 MG/ML Medicated Liquid Soap	SCD	157a14bf-f46e-49f8-96f4-a6c472eb5cb8	3
1233282	benzalkonium chloride 0.1 % Medicated Liquid Soap	SY	157a14bf-f46e-49f8-96f4-a6c472eb5cb8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-045-01	57337004501	444 g in 1 BOTTLE (57337-045-01)	444 g	2014-01-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Foam Antibacterial Hand Wash	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp	2024-02-28	HUMAN OTC DRUG LABEL	3