XtraCare Antibacterial Hand Cleanse

Product NDC: 57337-023
11-digit product format: 573370023
Labeler code: 57337
Product ID: 57337-023_126c40d2-9d18-e72a-e063-6294a90ad790
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: 2013-08-30
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: Strawberry Pomegranate
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
b68a7d64-2650-4fc6-a89e-05de9098a2a3	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-023-01	2024-02-28	C162847	48780-1	1030e365-0bcf-111a-e063-dadaa90a10e2	XtraCare Antibacterial Hand Cleanse
57337-023-01	2024-01-30	C162847	48780-1	1030e365-0bcf-111a-e063-dadaa90a10e2	XtraCare Antibacterial Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-023-01	XtraCare Antibacterial Hand CleanseStrawberry Pomegranate	221 mL in 1 BOTTLE	SOAP	221		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-023	XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20240229_b68a7d64-2650-4fc6-a89e-05de9098a2a3.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 101 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand Sanitizer	HAND SANITIZER UNSCENTED	CASAD Company, Inc	0933de73-94b1-448e-b39f-ecffabf95288	2024-10-09	Warnings	Exact identifier application number: M003
EVERSOFT FOAMING HAND ANTI-BACTERIAL	CHLOROXYLENOL	Draco Hygienic Products Inc.	e9d4767b-21f2-b68f-e053-2995a90a5aba	2024-10-08	Warnings	Exact identifier application number: M003
FOAMING HAND ALCOHOL FOAM	ALCOHOL	Draco Hygienic Products Inc.	14860a19-e1e8-71fc-e063-6394a90a9df8	2024-10-08	Warnings	Exact identifier application number: M003
FOAMING HAND ANTIBACTERIAL	CHLOROXYLENOL	Draco Hygienic Products Inc.	15256355-29ef-9b24-e063-6294a90a907d	2024-10-08	Warnings	Exact identifier application number: M003
Germ Attack Hand Sanitizer	ALCOHOL	Natural Essentials, Inc.	4d156264-566d-4516-876c-b6f5823a97f5	2024-10-04	Warnings	Exact identifier application number: M003
Germ Attack Hand Sanitizer	ALCOHOL	Natural Essentials, Inc.	9d3a4dfe-f31d-4def-bfc2-ece69d13f8e4	2024-10-04	Warnings	Exact identifier application number: M003
DiaSinc	BENZALKONIUM CHLORIDE	PureTek Corporation	d9ba1ca8-8883-11bb-e053-2995a90a5846	2024-10-02	Warnings	Exact identifier application number: M003
GenRx Hand Sanitizing	BENZALKONIUM CHLORIDE	PureTek Corporation	a12715c0-77f2-7716-e053-2995a90a06d3	2024-10-02	Warnings	Exact identifier application number: M003
Model AA-2012	MODEL AA-2012	AEROSPACE ACCESSORY SERVICE	e29b0f92-27b7-e09f-e053-2995a90a35e3	2024-10-01	Warnings	Exact identifier application number: M003
Hand Sanitizer Zytec Germ Buster	ALCOHOL 70%V/V	Empack Spraytech Inc.	f8f17337-6eac-465f-b961-3fec1c3c0f1f	2024-09-20	Warnings	Exact identifier application number: M003
Walmart	ISOPROPYL ALCOHOL	Walmart Inc.	d2b9f182-c341-c3b0-e053-2a95a90ac5a7	2024-09-18	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	2216a551-9fbe-3721-e063-6294a90af13d	2024-09-14	Warnings	Exact identifier application number: M003
Danielle Creations Hand Sanitizer - Strawberry	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	7c4bab88-af65-48c2-8440-3ba7b139c013	2024-09-10	Warnings	Exact identifier application number: M003
Danielle Creations Hand Sanitizer - Apple	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	362d3233-79ac-41d8-9991-b5fc75c6cae9	2024-09-10	Warnings	Exact identifier application number: M003
Danielle Creations Hand Sanitizer - Peach	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	ad28fe19-2b81-40c2-8ffb-f9b09c79def8	2024-09-10	Warnings	Exact identifier application number: M003
Thompson Antiseptic	BENZALKONIUM CHLORIDE	Thompson	0c009ed0-23b8-e4b3-e063-6394a90a723d	2024-09-04	Warnings	Exact identifier application number: M003
Bravo Sierra - Antibacterial Body Wipes	BENZALKONIUM CHLORIDE WIPES	Underscore USA	20ed5566-9014-e35b-e063-6294a90a003a	2024-08-30	Warnings	Exact identifier application number: M003
BERRIS AND CREAMY SCENTED HAND SANITIZER	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	30fc7f33-238c-42a3-93a1-72b98d303d9a	2024-08-28	Warnings	Exact identifier application number: M003
MANGO SORBET SCENTED HAND SANITIZER	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	d44e43e1-717d-47a1-a152-45f12288cbd2	2024-08-28	Warnings	Exact identifier application number: M003
COCONUT VANILLA SCENTED HAND SANITIZER	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	574324ee-d98b-4939-889c-21ed04a4e46d	2024-08-28	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	b68a7d64-2650-4fc6-a89e-05de9098a2a3	6
1020118	triclosan 1.5 MG/ML Medicated Liquid Soap	SCD	b68a7d64-2650-4fc6-a89e-05de9098a2a3	6
1020118	triclosan 0.15 % Medicated Liquid Soap	SY	b68a7d64-2650-4fc6-a89e-05de9098a2a3	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-023-01	57337002301	221 mL in 1 BOTTLE (57337-023-01)	221 ml	2013-08-30	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	6