XtraCare Antibacterial Hand Cleanse

Product NDC: 57337-021
11-digit product format: 573370021
Labeler code: 57337
Product ID: 57337-021_126c392a-2f26-cd97-e063-6294a90a4f99
Type: HUMAN OTC DRUG
Nonproprietary name: Triclosan
Dosage form: SOAP
Route: TOPICAL
Labeler: Rejoice International, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-09-03
Substance: TRICLOSAN
Active strength: 3.3 mg/221mL
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 Antibacterial Hand Cleanse
Brand name suffix: Original
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRICLOSAN	3.3 mg/221mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4NM5039Y5X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1020118	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
b5ce6663-fe82-4da1-923e-acea293d7a00	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-021-01	2024-02-28	C162847	48780-1	1030e365-2d71-111a-e063-dadaa90a10e2	XtraCare Antibacterial Hand Cleanse
57337-021-01	2024-01-30	C162847	48780-1	1030e365-2d71-111a-e063-dadaa90a10e2	XtraCare Antibacterial Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-021-01	XtraCare Antibacterial Hand CleanseOriginal	221 mL in 1 BOTTLE	SOAP	221		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-021	XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240229_b5ce6663-fe82-4da1-923e-acea293d7a00.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 61 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meijer Hand Sanitizer Lakeshore Fresh	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	41533b69-05e7-d5f7-e063-6294a90a2d2b	2025-10-16	Warnings	Exact identifier application number: M003
Meijer Hand Sanitizer Pine Forest	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4153ac2a-e51c-f167-e063-6394a90a80d8	2025-10-16	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Watermelon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	412e961a-b7d4-b1c2-e063-6294a90a6b85	2025-10-15	Warnings	Exact identifier application number: M003
equate First Aid Antiseptic	POVIDONE-IODINE	Walmart Inc.	43bbedec-be30-482a-8552-949b13d4bea1	2025-10-14	Warnings	Exact identifier application number: M003
Tridergel	BENZALKONIUM CHLORIDE	Trifluent Pharma LLC	f12d9e8c-1d69-49d9-a9e9-a392c681aa6c	2025-10-13	Warnings	Exact identifier application number: M003
Be Smart Get Prepared Sting Relief Wipe	BENZOCAINE, ALCOHOL	Total Resources International, Inc	5415073f-aa1d-4ed3-aa30-7470cd2efed1	2025-10-10	Warnings	Exact identifier application number: M003
Lemyn Organics Medical-Grade Hand Sanitizer	ALCOHOL	Lemyn LLC	b106289d-346a-74df-e053-2995a90aa426	2025-10-10	Warnings	Exact identifier application number: M003
Dr Lift Antibacterial Body Wash	BENZALKONIUM CHLORIDE	Spa de Soleil	ab9dde33-1bd2-062f-e053-2a95a90a4d18	2025-10-10	Warnings	Exact identifier application number: M003
Dr Lift Antibacterial	BENZALKONIUM CHLORIDE	Spa de Soleil	af89675e-e66f-0922-e053-2995a90ab9d2	2025-10-10	Warnings	Exact identifier application number: M003
ANTISEPTIC WIPE 01	BENZALKONIUM CHLORIDE	Total Resources International Inc.	cf4a6a97-529e-7f11-e053-2a95a90a75a9	2025-10-10	Warnings	Exact identifier application number: M003
Be Smart Get Prepared Sting Relief Wipe	ALCOHOL, LIDOCAINE HYDROCHLORIDE	Total Resources International, Inc	fff6f057-739e-40f1-8427-e1364c65af05	2025-10-09	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	Zhejiang Hudson Import& Export Co., Ltd	40b6c96c-e36f-6588-e063-6394a90adb46	2025-10-09	Warnings	Exact identifier application number: M003
Curad	ISOPROPYL ALCOHOL	Medline Industries, LP	c42de981-4e3f-1ac9-e053-2995a90aea98	2025-10-09	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	Avaria Health & Beauty Corp	a3d87ef6-752b-b54b-e053-2a95a90af963	2025-10-08	Warnings	Exact identifier application number: M003
Iodo Blanco (Iodine Tincture Decolorized) First Aid Antiseptic	IODINE 2%	Germa Products, LLC	bf54254f-2ef3-102e-e053-2995a90ac083	2025-10-08	Warnings	Exact identifier application number: M003
MediChoice BZK Antiseptic	BENZALKONIUM CHLORIDE	O&M HALYARD, INC.	82a7710d-a9fa-4f68-8322-046a765ae929	2025-10-08	Warnings	Exact identifier application number: M003
MediChoice Cleansing	BENZALKONIUM CHLORIDE	O&M HALYARD, INC.	79d41cf0-301f-44d4-a76c-f4850c7ddce9	2025-10-08	Warnings	Exact identifier application number: M003
MediChoice Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	O&M HALYARD, INC.	8b84c8ed-040e-4c07-94cb-d5bdda744648	2025-10-08	Warnings	Exact identifier application number: M003
MediChoice of Hydrogen Peroxide 3 10 Volume	HYDROGEN PEROXIDE	O&M HALYARD, INC.	34e77ef4-297d-4362-8f6e-abf80158b7f0	2025-10-08	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	O&M HALYARD, INC.	0ad5990a-a18d-4753-826b-6da313926698	2025-10-08	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4NM5039Y5X	TRICLOSAN	3380-34-5	TRICLOSAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1020118	triclosan 0.15 % Medicated Liquid Soap	PSN	b5ce6663-fe82-4da1-923e-acea293d7a00	5
1020118	triclosan 1.5 MG/ML Medicated Liquid Soap	SCD	b5ce6663-fe82-4da1-923e-acea293d7a00	5
1020118	triclosan 0.15 % Medicated Liquid Soap	SY	b5ce6663-fe82-4da1-923e-acea293d7a00	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-021-01	57337002101	221 mL in 1 BOTTLE (57337-021-01)	221 ml	2013-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Antibacterial Hand Cleanse	Rejoice International, Inc. \| China Ningbo Shangge Cosmetic Technology Corp.	2024-02-28	HUMAN OTC DRUG LABEL	5