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 80 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUPER SUDS ANTIBACTERIAL HAND ITEM 1063	CHLOROXYLENOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	1871e729-6b76-084e-e063-6394a90a795d	2025-04-23	Warnings	Exact identifier application number: M003
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED	LIDOCAINE, MENTHOL	Compass Health Brands Corp.	2c38a4be-fcbe-9d1d-e063-6294a90a9373	2025-04-22	Warnings	Exact identifier application number: M003
Sierra Soft Antibacterial Wash	CHLOROXYLENOL	CWGC LA Inc.	49034ae5-be47-4472-a4e5-b5bf633355ed	2025-04-21	Warnings	Exact identifier application number: M003
Aplicare	HYDROGEN PEROXIDE	Aplicare Products LLC	0b3e5df6-03c8-3880-e063-6394a90a1cdc	2025-04-18	Warnings	Exact identifier application number: M003
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Total Resources International	b971cc41-fe23-4be3-9564-e46d55df1d68	2025-04-18	Warnings	Exact identifier application number: M003
Sierra Soft Alcohol Hand Sanitizer	ETHYL ALCOHOL	CWGC LA Inc.	012463da-94cf-4975-9fa2-6c323855bf57	2025-04-17	Warnings	Exact identifier application number: M003
Biopure	HAND SANITIZER SPRAY	Quest USA Corp	323c61fd-adee-393c-e063-6394a90a5eb3	2025-04-15	Warnings	Exact identifier application number: M003
Biopure	HAND SANITIZER SPRAY	Quest USA Corp	324b140d-9d43-1c2f-e063-6294a90ae303	2025-04-15	Warnings	Exact identifier application number: M003
Isopropyl alcohol 70 percent	ISOPROPYL ALCOHOL	TARGET Corporation	126ec829-c54c-4927-bbd5-a8156d2f6eea	2025-04-14	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Apple	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	32b88e9f-d3e7-c78c-e063-6294a90a6707	2025-04-14	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Gingerbread	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3269a702-59a3-af3b-e063-6394a90a97d2	2025-04-14	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Spicy Cranberry	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	32b8e946-b52b-fa2e-e063-6294a90ae1a7	2025-04-14	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Pine Forest	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	32b920b7-91b4-52df-e063-6394a90a745e	2025-04-14	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitize Mistletoe	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	32b95351-5115-7200-e063-6394a90a5840	2025-04-14	Warnings	Exact identifier application number: M003
Be Smart Get Prepared Alcohol Prep Pad	ISOPROPYL ALCOHOL	Total Resources International, Inc	6f2a4cb9-eea9-4894-b774-759f27b6f9a8	2025-04-14	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	9c85129b-29fa-4393-a9b4-b8ea1ba5be54	2025-04-14	Warnings	Exact identifier application number: M003
Isopropyl alcohol 70 percent Wintergreen	ISOPROPYL ALCOHOL	TARGET Corporation	f4ea4aa4-42c6-456b-9908-24f256d4a769	2025-04-14	Warnings	Exact identifier application number: M003
Isopropyl alcohol Wintergreen	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	8dac7168-0140-470f-bf66-fd0aed519b38	2025-04-14	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	227b9292-0be7-47ef-ac8e-a9a8cc2fb416	2025-04-14	Warnings	Exact identifier application number: M003
Be Smart Get Prepared Antiseptic Wipe	BENZALKONIUM CHLORIDE	Total Resources International, Inc	f2151af3-d76a-490f-90ff-728c350fe168	2025-04-11	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