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 63 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl alcohol	ISOPROPYL ALCOHOL	Family Dollar (FAMILY WELLNESS)	1a3a789d-8c51-4661-84fe-df80ed70e6f1	2025-10-03	Warnings	Exact identifier application number: M003
Equate Antibacterial Fresh Hand Wipes	BENZALKONIUM CHLORIDE	Walmart, Inc.	d2bc26d8-3e46-e479-e053-2995a90abc0a	2025-10-01	Warnings	Exact identifier application number: M003
Equate Antibacterial Wipes Fresh	BENZALKONIUM CHLORIDE	Walmart, Inc.	21d86d5b-46ee-6ffd-e063-6394a90ab0e5	2025-10-01	Warnings	Exact identifier application number: M003
Equate Antibacterial Wipes Citrus	BENZALKONIUM CHLORIDE	Walmart, Inc.	2450dc1b-0c89-c92a-e063-6394a90afe22	2025-10-01	Warnings	Exact identifier application number: M003
Equate Antibacterial Citrus Hand Wipes	BENZALKONIUM CHLORIDE	Walmart, Inc.	d2cb4c64-66fc-58e4-e053-2a95a90a7f66	2025-10-01	Warnings	Exact identifier application number: M003
Kroger Antibacterial Hand Wipes	BENZALKONIUM CHLORIDE	The Kroger Co.	17e29138-8c1f-e3b1-e063-6294a90a5d48	2025-10-01	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Family Dollar (FAMILY WELLNESS)	2f1c3e24-ea71-4634-9ec1-670349b43a50	2025-10-01	Warnings	Exact identifier application number: M003
Fresh Feels Hand Sanitizer Mist	FRESH FEELS HAND SANITIZER MIST	ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD	3ffda86b-6b1d-8f0d-e063-6394a90aafaf	2025-09-30	Warnings	Exact identifier application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPES	BENZALKONIUM CHLORIDE	Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.	ee484505-3bb1-2989-e053-2995a90aea2b	2025-09-30	Warnings	Exact identifier application number: M003
Xpect First Aid Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCL	Cintas Corporation	f7112e5d-c8c4-42ad-8a65-24bfc32d4aea	2025-09-30	Warnings	Exact identifier application number: M003
Xpect Antiseptic Wipes	ANTISEPTIC CLEANSER	Cintas Corporation	8f1fd933-965e-42ec-ab96-47cfe780f963	2025-09-29	Warnings	Exact identifier application number: M003
EVR Alcohol Prep Pads	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd.	3ffba233-6106-f633-e063-6394a90a96fe	2025-09-29	Warnings	Exact identifier application number: M003
ProHeal Alcohol Prep Pad	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd.	3ffc0619-eb13-77af-e063-6394a90a2fd9	2025-09-29	Warnings	Exact identifier application number: M003
ProHeal BZK Antiseptic Towelettes	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd.	3ffc3f34-086d-1d18-e063-6294a90a71bb	2025-09-29	Warnings	Exact identifier application number: M003
First Aid Direct Alcohol Wipe	ISOPROPYL ALCOHOL	Cintas Corporation	6a71449e-9a97-4923-8ec1-b1deb45b5746	2025-09-29	Warnings	Exact identifier application number: M003
Northside Hospital Mothers Kit, Grey Backpack	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	0868060e-d593-4cb2-b3d2-6c59d1ae5efc	2025-09-29	Warnings	Exact identifier application number: M003
First Aid Direct Antiseptic Wipe	BENZALKONIUM CHLORIDE	Cintas Corporation	a23f3685-7213-4cc0-97b2-588fb1224792	2025-09-29	Warnings	Exact identifier application number: M003
Xpect Alcohol Wipes	ALCOHOL WIPES	Cintas Corporation	51185b9a-ed6b-4a49-b524-b3ff0d5c6290	2025-09-29	Warnings	Exact identifier application number: M003
Super-Stop BloodClotter	BLOOD CLOTTER	Cintas Corp	d910ee9b-187d-49a9-ab96-281730db2575	2025-09-26	Warnings	Exact identifier application number: M003
Hand Sanitizer plus Holder	BENZALKONIUM CHLORIDE	Aocai Biotechnology Huizhou Co Ltd	3fa738ce-0a04-fa11-e063-6294a90aba88	2025-09-25	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