XtraCare Foaming Hand Sanitizer

Product NDC: 57337-057
11-digit product format: 573370057
Labeler code: 57337
Product ID: 57337-057_126d7580-4eff-8635-e063-6294a90a77c0
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: GEL
Route: TOPICAL
Labeler: Rejoice International
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-02-18
Substance: BENZALKONIUM CHLORIDE
Active strength: 3 g/207g
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 Foaming Hand Sanitizer
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	3 g/207g

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
1098199	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
3082cbbb-a0ed-45eb-a116-ad1c65357dd1	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-057-01	2024-02-28	C162847	48780-1	1030e365-045d-111a-e063-dadaa90a10e2	XtraCare Foaming Hand Sanitizer
57337-057-01	2024-01-30	C162847	48780-1	1030e365-045d-111a-e063-dadaa90a10e2	XtraCare Foaming Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-057-01	XtraCare Foaming Hand Sanitizer	207 g in 1 PACKAGE	GEL	207		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	1
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	1
CETRIMONIUM CHLORIDE	INACTIVE INGREDIENT	UC9PE95IBP	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	1
DISODIUM COCOAMPHODIACETATE	INACTIVE INGREDIENT	18L9G3U51M	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-057	XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]	3	Current NDC, Legacy NDC, 1 package rows	20240229_3082cbbb-a0ed-45eb-a116-ad1c65357dd1.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 100 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl Rubbing Alcohol 50% with Wintergreen	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	0b185535-b1af-4128-89ca-65b0e63cd430	2024-10-21	Warnings	Exact identifier application number: M003
HAND SANITIZER RAINFALL	ALCOHOL	SCENT THEORY PRODUCTS LLC	24b1a25c-a3b6-9278-e063-6394a90a3ae2	2024-10-17	Warnings	Exact identifier application number: M003
HAND SANITIZER RASPBERRY MANGO	ALCOHOL	SCENT THEORY PRODUCTS LLC	24b19489-4e59-0df8-e063-6394a90af6ae	2024-10-17	Warnings	Exact identifier application number: M003
HAND SANITIZER BRAZILIAN COCONUT	ALCOHOL	SCENT THEORY PRODUCTS LLC	24b1992a-d695-32b2-e063-6394a90a6cab	2024-10-17	Warnings	Exact identifier application number: M003
HAND SANITIZER LUSH ALOE	ALCOHOL	SCENT THEORY PRODUCTS LLC	24b1a25c-a3b8-9278-e063-6394a90a3ae2	2024-10-17	Warnings	Exact identifier application number: M003
CICLOFERON	BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	Laboratorios Liomont, S.A. de C.V.	89081ef8-9721-a476-e053-2995a90ae0de	2024-10-17	Warnings	Exact identifier application number: M003
Bebesup Antibacterial Handy Wipes	BENZALKONIUM CHLORIDE	AJ Co., Ltd.	24b75970-5138-ce50-e063-6394a90a123c	2024-10-17	Warnings	Exact identifier application number: M003
HAND SANITIZER SANDALWOOD WAVES	ALCOHOL	SCENT THEORY PRODUCTS LLC	24893800-464a-16ca-e063-6294a90a9065	2024-10-16	Warnings	Exact identifier application number: M003
First Aid Only BZK Antiseptic Towelettes	BENZALKONIUM CHLORIDE	Acme United Corporation	c927f845-1383-ae85-e053-2995a90a12fc	2024-10-15	Warnings	Exact identifier application number: M003
First Aid Only BZK Antiseptic	BENZALKONIUM CHLORIDE	Acme United Corporation	dbed7ed6-a9b8-7b59-e053-2a95a90ac0cb	2024-10-15	Warnings	Exact identifier application number: M003
HILL COUNTRY FARE HAND SANITIZER WITH ALOE FRAGRANCE	ALCOHOL	H.E.B	c89b48e9-1746-874b-e053-2995a90ab071	2024-10-15	Warnings	Exact identifier application number: M003
HEB Citrus Hand Sanitizer	ALCOHOL	H.E.B.	c8ab20e5-6a20-5a6b-e053-2a95a90a247c	2024-10-15	Warnings	Exact identifier application number: M003
Instant Hand Sanitizing Wipe	ETHYL ALCOHOL	McKesson	9f51a505-2d55-5c49-e053-2a95a90a2403	2024-10-14	Warnings	Exact identifier application number: M003
Swab	POVIDONE-IODINE	McKesson Medical-Surgical Inc.	4777b5f4-1698-08da-e054-00144ff8d46c	2024-10-14	Warnings	Exact identifier application number: M003
Walgreens Sunburn Relief	LIDOCAINE HYDROCHLORIDE	WALGREEN COMPANY	d4c9913d-fcac-4785-e053-2995a90a7917	2024-10-14	Warnings	Exact identifier application number: M003
Target Up and Up 2-in-1 Hand Sanitizer	BENZETHONIUM CHLORIDE	TARGET CORPORATION	e069c9e6-024d-5482-e053-2995a90a767d	2024-10-14	Warnings	Exact identifier application number: M003
Meridian Wrapped antibacterial Deodorant	BENZETHONIUM CHLORIDE	Bob Barker Company Inc.	7c834c1d-7930-4909-a600-6de9698e2b17	2024-10-14	Warnings	Exact identifier application number: M003
Meridian Unwrapped antibacterial Deodorant	BENZETHONIUM CHLORIDE	Bob Barker Company Inc.	adc10d22-a913-4bfa-a3f7-d6d5778f07ca	2024-10-14	Warnings	Exact identifier application number: M003
First Aid Antiseptic Pain Relieving	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Hubei Changjian Medical Products Co., Ltd.	9cb3759a-35d9-4f6b-94ad-fafd4bc600bd	2024-10-11	Warnings	Exact identifier application number: M003
Antiseptic Towelette	BENZALKONIUM CHLORIDE	Hubei Changjian Medical Products Co., Ltd.	bf045881-9636-4000-a0ac-f6aab6b81832	2024-10-11	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
1098199	benzalkonium chloride 0.13 % Topical Gel	PSN	3082cbbb-a0ed-45eb-a116-ad1c65357dd1	3
1098199	benzalkonium chloride 0.0013 MG/MG Topical Gel	SCD	3082cbbb-a0ed-45eb-a116-ad1c65357dd1	3
1098199	benzalkonium chloride 0.13 % Topical Gel	SY	3082cbbb-a0ed-45eb-a116-ad1c65357dd1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-057-01	57337005701	207 g in 1 PACKAGE (57337-057-01)	207 g	2014-02-18	0000-00-00	No	No	Current

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