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 106 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate	TRICLOSAN	Rejoice International, Inc.	b68a7d64-2650-4fc6-a89e-05de9098a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Mountain Spring	TRICLOSAN	Rejoice International, Inc.	c31723d5-a313-448a-8b69-ca5f8dec25ed	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	a9a1467c-abcc-4ccb-88f6-430279609788	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	9fa9d955-7167-4a0a-935b-2a600f439eb0	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	157a14bf-f46e-49f8-96f4-a6c472eb5cb8	2024-02-28	Warnings	Exact identifier application number: M003 ndc (product): 57337-045
XtraCare Foaming Hand Sanitizer	BENZALKONIUM CHLORIDE	Rejoice International	3082cbbb-a0ed-45eb-a116-ad1c65357dd1	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	45b3ca49-edb4-4840-b857-d24045494a3a	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	4890f81e-7994-4ea2-9412-5614c405a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	5c109f7c-1f4d-484a-b6ea-3bbcf572bbac	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Hand Sanitizer Moisurize with Vitamin E and Aloe	ETHYL ALCOHOL	Rejoice International	2851ad2a-e108-424c-86d6-c898567695ef	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Hand Sanitizer Moisturize with Vitamin E	ETHYL ALCOHOL	Rejoice International	13c99570-0859-4310-843a-5eb266698eb3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International	a339dfd9-7cb8-4198-bc2a-9759648cf34e	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International	f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72	2024-02-28	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd	11ef87cc-6ff6-511b-e063-6294a90a662f	2024-02-21	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER	ETHYL ALCOHOL	MY IMPORTS USA LLC	11f19126-6abb-b14c-e063-6294a90a4e34	2024-02-21	Warnings	Exact identifier application number: M003
Antiseptic	ANTISEPTIC SPRAY	Dynarex Corporation	118192ac-7173-09c5-e063-6394a90ad550	2024-02-16	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL SPRAY	Dynarex Corporation	116e0c9c-cbe0-bf67-e063-6394a90ae530	2024-02-15	Warnings	Exact identifier application number: M003
POVIDONE-IODINE	POVIDONE-IODINE	HART Health	92b6a38e-c7bb-45e2-9c2a-7993ed1bac36	2024-02-15	Warnings	Exact identifier application number: M003
Povidone Iodine Gel Swabstick	POVIDONE IODINE GEL SWABSTICK	Dynarex Corporation	eb7e21be-521e-2d52-e053-2a95a90ade33	2024-02-13	Warnings	Exact identifier application number: M003
Antiseptic	ALCOHOL, LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	71aeaf86-2b4d-4945-9606-a9db0ab6b726	2024-02-07	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