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 108 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
White Petrolatum	WHITE PETROLATUM	Nantong Health & Beyond Hygienic Products Inc.	0f0d6ff0-ff30-aaf8-e063-6394a90a2716	2024-01-16	Warnings	Exact identifier application number: M003
Thompson Hand Sanitizer	ETHYL ALCOHOL	Thompson	deada606-8a82-9eeb-e053-2a95a90a9e6d	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Arnica Gel	ARNICA MONTANA	Nantong Health & Beyond Hygienic Products Inc.	0ef8760d-27c0-7ece-e063-6294a90a6873	2024-01-15	Warnings	Exact identifier application number: M003
American Safety First Aid Antispetic	HYDROGEN PEROXIDE	Orazen Inc	ea2fbdfe-1932-9fb4-e053-2a95a90a3563	2024-01-15	Warnings	Exact identifier application number: M003
First Aid Antispetic	BENZALKONIUM CHLORIDE	Orazen Inc	ea2debcb-892c-339f-e053-2a95a90a4b18	2024-01-15	Warnings	Exact identifier application number: M003
Ever Ready First Aid	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Ever Ready First Aid	e53f3bf5-25c0-2b86-e053-2a95a90a010f	2024-01-15	Warnings	Exact identifier application number: M003
FIRST SHIELD First Aid Antiseptic	BENZALKONIUM CHLORIDE	Ever Ready First Aid	e013ef0a-ef3d-7af5-e053-2a95a90a54d3	2024-01-15	Warnings	Exact identifier application number: M003
Latalia Hand Sanitizer 80 Alcohol Antiseptic	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD	ae55fab3-3177-383e-e053-2995a90a17a0	2024-01-10	Warnings	Exact identifier application number: M003
Latalia Sanitizing Wipe	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD	ae564635-898e-fbf6-e053-2995a90a8119	2024-01-10	Warnings	Exact identifier application number: M003
Latalia Sanitizing Wipes	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD	af850b5e-c99f-3d4e-e053-2995a90a7948	2024-01-10	Warnings	Exact identifier application number: M003
Latalia Alcohol Antiseptic 80 Sanitizing	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD	ba4b8fb3-09db-fa29-e053-2995a90a8617	2024-01-10	Warnings	Exact identifier application number: M003
Northside Hospital Amenity Kit--GI Dept	ALCOHOL	ASP Global, LLc	c284eba4-0b92-4981-b3f8-d8d99b58bdfd	2024-01-10	Warnings	Exact identifier application number: M003
Meijer 3 Hydrogen Peroxide Wipes	HYDROGEN PEROXIDE	Meijer, Inc.	33143d87-3e57-4a17-a96c-b699ad034b5b	2024-01-09	Warnings	Exact identifier application number: M003
Meijer 70 Isopropyl Alcohol Wipes First Aid Antiseptic	ISOPROPYL ALCOHOL	Meijer, Inc	2046162f-cb70-416c-ae37-14999883a807	2024-01-09	Warnings	Exact identifier application number: M003
Lightning X Antiseptic	BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	0e6b10e7-6e84-6bfc-e063-6294a90a8537	2024-01-08	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE 3.0%	Trifecta Pharmaceuticals USA, LLC.	e4e45f11-7cd4-e693-e053-2a95a90a4c34	2024-01-02	Warnings	Exact identifier application number: M003
GLOBAL CARE GOLD ANTIBACTERIAL HAND	BENZALKONIUM CHLORIDE	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	27ba0f30-e066-f240-e063-6394a90ae7cb	2024-01-01	Warnings	Exact identifier application number: M003
Freskaro Decolorized Iodine	ALCOHOL	Pharma Nobis, LLC	fbd222a2-1151-99b9-e053-6394a90a8bb8	2023-12-28	Warnings	Exact identifier application number: M003
Alcohol Prep	ISOPROPYL ALCOHOL	Topco Associates	65270825-48b1-49e7-a14e-f73df9beb9dd	2023-12-27	Warnings	Exact identifier application number: M003
Humco Hydrogen Peroxide	HYDROGEN PEROXIDE 3%	Pharma Nobis, LLC	e42f876d-0477-c4d5-e053-2a95a90ae6d4	2023-12-26	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