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 99 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Peppermint Hand Sanitizer	ALCOHOL	Natural Essentials, Inc.	25cb382a-6e66-05e6-e063-6294a90a9165	2024-10-31	Warnings	Exact identifier application number: M003
RITE AID Maximum strength pain relieving	BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	RITE AID	c87671cb-d736-4ec6-ab10-94dff54925b2	2024-10-30	Warnings	Exact identifier application number: M003
H2OCEAN NOTHING	BENZALKONIUM CL, LIDOCAINE HCL	H2Ocean, LLC	77896ac3-960c-41ac-8b40-053f24526fe3	2024-10-23	Warnings	Exact identifier application number: M003
Blue Green Foam	BENZALKONIUM CHLORIDE	H2Ocean, LLC	8627bf8b-2cce-45de-b37f-8478462645fa	2024-10-23	Warnings	Exact identifier application number: M003
CVS HEALTH CONTINUOUS HAND SANITIZER	ALCOHOL	CVS PHARMACY	c89a28ac-ab53-46dd-e053-2a95a90a3284	2024-10-22	Warnings	Exact identifier application number: M003
TRADER JOES HAND SANITIZER LAVENDER	ETHYL ALCOHOL	Trader Joe's Company	4d782831-dab8-4553-9786-b5172813553e	2024-10-22	Warnings	Exact identifier application number: M003
TRADER JOES HAND SANITIZER GRAPEFRUIT LEMON	ALCOHOL	Trader Joe's Company	f4c1e80a-847b-4407-92b7-570c032bea60	2024-10-22	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol 99%	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	678a9b14-2838-4358-9673-fc23e0f58efb	2024-10-21	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol 70%	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	a9960d2f-f13a-4168-b2e9-d6f4a35d84ae	2024-10-21	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol 50%	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	5db1659e-3a13-47f0-90ae-f8f192c6111a	2024-10-21	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol 70% with Wintergreen	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	3dcdc1cc-ece8-4b47-a236-ee57c375bb99	2024-10-21	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol 50% with Wintergreen	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	0b185535-b1af-4128-89ca-65b0e63cd430	2024-10-21	Warnings	Exact identifier application number: M003
HAND SANITIZER RAINFALL	ALCOHOL	SCENT THEORY PRODUCTS LLC	24b1a25c-a3b6-9278-e063-6394a90a3ae2	2024-10-17	Warnings	Exact identifier application number: M003
HAND SANITIZER RASPBERRY MANGO	ALCOHOL	SCENT THEORY PRODUCTS LLC	24b19489-4e59-0df8-e063-6394a90af6ae	2024-10-17	Warnings	Exact identifier application number: M003
HAND SANITIZER BRAZILIAN COCONUT	ALCOHOL	SCENT THEORY PRODUCTS LLC	24b1992a-d695-32b2-e063-6394a90a6cab	2024-10-17	Warnings	Exact identifier application number: M003
HAND SANITIZER LUSH ALOE	ALCOHOL	SCENT THEORY PRODUCTS LLC	24b1a25c-a3b8-9278-e063-6394a90a3ae2	2024-10-17	Warnings	Exact identifier application number: M003
CICLOFERON	BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	Laboratorios Liomont, S.A. de C.V.	89081ef8-9721-a476-e053-2995a90ae0de	2024-10-17	Warnings	Exact identifier application number: M003
Bebesup Antibacterial Handy Wipes	BENZALKONIUM CHLORIDE	AJ Co., Ltd.	24b75970-5138-ce50-e063-6394a90a123c	2024-10-17	Warnings	Exact identifier application number: M003
HAND SANITIZER SANDALWOOD WAVES	ALCOHOL	SCENT THEORY PRODUCTS LLC	24893800-464a-16ca-e063-6294a90a9065	2024-10-16	Warnings	Exact identifier application number: M003
First Aid Only BZK Antiseptic Towelettes	BENZALKONIUM CHLORIDE	Acme United Corporation	c927f845-1383-ae85-e053-2995a90a12fc	2024-10-15	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