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 26 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PINK SUGAR SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5005eac6-4032-23e0-e063-6294a90a81b5	2026-04-01	Warnings	Exact identifier application number: M003
VANILLA DREAM SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	50060be0-ec68-c82b-e063-6394a90aa723	2026-04-01	Warnings	Exact identifier application number: M003
STRAWBERRY FIZZ SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	500621d8-bc77-218d-e063-6394a90ad05f	2026-04-01	Warnings	Exact identifier application number: M003
MISTIFY COCONUT VANILLA HYDRATING HAND SANITISER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5006097e-16e5-d180-e063-6394a90ae0c2	2026-04-01	Warnings	Exact identifier application number: M003
MISTIFY STRAWBERRY SUGAR HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5006b3d5-5444-539f-e063-6294a90ad771	2026-04-01	Warnings	Exact identifier application number: M003
MISTIFY TROPICAL VANILLA HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5007713f-d8a3-03da-e063-6394a90afd5a	2026-04-01	Warnings	Exact identifier application number: M003
MISTIFY FRUIT PUNCH HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5007320e-de0f-2dc0-e063-6394a90a0510	2026-04-01	Warnings	Exact identifier application number: M003
MISTIFY PINA COLADA HAND SANITEZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	50698e2f-c3c0-eabd-e063-6394a90a45d9	2026-04-01	Warnings	Exact identifier application number: M003
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Prostat First Aid	4cd5d67d-43d8-f6d2-e063-6394a90a4070	2026-03-31	Warnings	Exact identifier application number: M003
HealthWise Advanced Hand Sanitizer with Aloe	ETHYL ALCOHOL 70%	Veridian Healthcare	4e55e971-775a-0d69-e063-6394a90a7956	2026-03-31	Warnings	Exact identifier application number: M003
Isopro First Aid	ISOPROPYL ALCOHOL	Water-Jel Technologies	f38563f5-ee54-4979-9157-4bf8fd60daab	2026-03-31	Warnings	Exact identifier application number: M003
Verifine Alcohol Swabs	ALCOHOL SWABS	Promisemed Hangzhou Meditech Co.,LTD.	4e404989-89d0-b189-e063-6394a90a8caa	2026-03-30	Warnings	Exact identifier application number: M003
MedPride Sterile Prep Pads	ISOPROPYL ALCOHOL	Shield Line LLC	31de24d8-b70e-47f1-8946-6bd9fb16b5d5	2026-03-30	Warnings	Exact identifier application number: M003
FIGS - evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar Scented	ETHYL ALCOHOL	WE EVOLVETOGETHER INC.	4e432300-7d2f-ed59-e063-6394a90a22b8	2026-03-30	Warnings	Exact identifier application number: M003
Bedside-Care Foam (Alcohol Free)	BENZETHONIUM CHLORIDE	Coloplast Corp	3e8a37f0-3b44-4bba-8987-2717b54419f1	2026-03-30	Warnings	Exact identifier application number: M003
Bedside-Care	BENZETHONIUM CHLORIDE	Coloplast Corp	e0cf033c-82fa-4b5a-b2be-5b0d13c0cea0	2026-03-30	Warnings	Exact identifier application number: M003
Isagel	ALCOHOL	Coloplast Corp	eba7e574-25c2-445a-98f6-2d1045455466	2026-03-27	Warnings	Exact identifier application number: M003
TOTO Antibacterial Foam HandSoap	PEACHY FOAM	Toto U.S.A, Inc	4e03343c-3299-4e26-e063-6394a90a7bbd	2026-03-27	Warnings	Exact identifier application number: M003
Sani Mango Antiseptic Hand and Body Wash	CHLOROXYLENOL	ABC Compounding Co., Inc.	660f1087-4240-4dcc-864f-be2bc20abd3a	2026-03-27	Warnings	Exact identifier application number: M003
Isagel	ALCOHOL	Coloplast Corp	5be93a24-c644-4e6b-a600-87f0a5a09e5c	2026-03-27	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