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 110 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Harris Teeter Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Harris Teeter, LLC	5c88d7cb-2917-54e9-e053-2991aa0a0bd9	2023-12-20	Warnings	Exact identifier application number: M003
CVS Iodine	IODINE, SODIUM IODIDE AND ALCOHOL	CVS Pharmacy	b11db4e5-6a6d-4d4a-b980-600692b54176	2023-12-20	Warnings	Exact identifier application number: M003
CVS Povidone-Iodine	POVIDONE IODINE	CVS Pharmacy	402d571f-e1e8-43fd-9e7b-05aab1837905	2023-12-20	Warnings	Exact identifier application number: M003
Sanitizing wipes with aloe Grapefruit Grove	ALCOHOL	The Honest Company	faa3690b-ce0d-43d4-9e5c-f2ce77daabe7	2023-12-19	Warnings	Exact identifier application number: M003
Sanitizing Wipes Fragrance Free	ALCOHOL	The Honest Company	0ce3e7ee-aa50-16bc-e063-6294a90a527d	2023-12-19	Warnings	Exact identifier application number: M003
sunmark Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	46da2750-37d1-4ed1-baf3-1fd426617567	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Iodine	IODINE, SODIUM IODIDE, ALCOHOL	Strategic Sourcing Services LLC	e8dae2d6-58b1-4c4e-a4c1-371db055b7ae	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Isopropyl Alcohol 70 Percent With Wintergreen Oil	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	515dd733-1b44-4df0-928f-a3b202b5f9c2	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Isopropyl Alcohol 91 Percent	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	92afb1ce-6a9e-456e-b3ee-e8a8d93ebc5e	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Strategic Sourcing Services LLC	c79ae066-8b3b-400d-8b26-f41100e7f534	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Iodides Tincture	ETHYL ALCOHOL	Strategic Sourcing Services LLC	5e227f79-fca7-4633-97ea-61da4060fe92	2023-12-19	Warnings	Exact identifier application number: M003
sunmark Povidone-Iodine Topical	POVIDONE-IODINE	Strategic Sourcing Services LLC	acc349d6-2875-4814-aa6e-828fffec7f07	2023-12-19	Warnings	Exact identifier application number: M003
DDM Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Discount Drug Mart	5d538c8e-bf87-d85c-e053-2991aa0af729	2023-12-19	Warnings	Exact identifier application number: M003
DDM Decolorized Iodine	ETHYL ALCOHOL	Discount Drug Mart	5d570ea7-ab08-54b7-e053-2991aa0a7a83	2023-12-19	Warnings	Exact identifier application number: M003
DDM Povidone Iodine	POVIDONE IODINE 10%	Discount Drug Mart	5d161a9d-0462-0afd-e053-2991aa0a22e2	2023-12-19	Warnings	Exact identifier application number: M003
HEB Povidone Iodine	POVIDONE IODINE 10%	H E B	5d576ce2-7d63-c860-e053-2a91aa0a072c	2023-12-18	Warnings	Exact identifier application number: M003
Publix Povidone Iodine	POVIDONE IODINE 10%	Publix	5d6bba46-2571-4957-e053-2a91aa0a2e85	2023-12-18	Warnings	Exact identifier application number: M003
Top Care Decolorized Iodine	ETHYL ALCOHOL	TOPCO ASSOCIATES LLC	5d6bdc17-5c3a-7dec-e053-2991aa0aa450	2023-12-18	Warnings	Exact identifier application number: M003
Tincture Merthiolate	BENZALKONIUM CHLORIDE	DLC Laboratories, Inc	4fec9119-fbbf-4fc7-9122-c6300cac8731	2023-12-18	Warnings	Exact identifier application number: M003
70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN	ISOPROPYL ALCOHOL	New Pride Corp	0c9e1e9c-b8fc-1932-e063-6394a90a09bf	2023-12-16	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