Liquid Hand Cleanse

Product NDC: 57337-016
Requested package NDC: 57337-016-01
11-digit product format: 573370016
Labeler code: 57337
Product ID: 57337-016_126c392a-2f25-cd97-e063-6294a90a4f99
Type: HUMAN OTC DRUG
Nonproprietary name: Triclosan
Dosage form: GEL
Route: TOPICAL
Labeler: Rejoice International, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-07-05
Substance: TRICLOSAN
Active strength: 10 mg/500mg
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: Liquid Hand Cleanse
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRICLOSAN	10 mg/500mg

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
413246	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
23ff5450-8308-41c0-9052-1ac4c4433d6c	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-016-01	2024-02-29	C162847	48780-1	1030e365-4af0-111a-e063-dadaa90a10e2	Liquid Hand Cleanse
57337-016-01	2024-01-30	C162847	48780-1	1030e365-4af0-111a-e063-dadaa90a10e2	Liquid Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-016-01	Liquid Hand Cleanse	500 mg in 1 BOTTLE	GEL	500		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
CETETH-7	INACTIVE INGREDIENT	4ST6952Q67	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
DIETHANOLAMINE	INACTIVE INGREDIENT	AZE05TDV2V	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
ETHYL SULFATE	INACTIVE INGREDIENT	P3LK0HF3B7	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
OCTHILINONE	INACTIVE INGREDIENT	4LFS24GD0V	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-016	LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240301_23ff5450-8308-41c0-9052-1ac4c4433d6c.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 96 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DK12 Shower Gel Fresh Energy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	05e4ff0e-ef63-ef3b-e063-6294a90aa2b8	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Vitamin E Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe9270c0-bf6b-f0ff-e053-6394a90ae8f1	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Creamy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e2e51b-212b-368e-e063-6294a90a871c	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Fresh Energy Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe80635d-9594-abf3-e053-6394a90aa78b	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Shower Gel Creamy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	05e36111-ed4e-12de-e063-6294a90af639	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Creamy Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe7fde7e-82fc-c13f-e053-6394a90aff68	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Oatmeal Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe16387b-1b16-1f41-e053-6294a90ae2c0	2024-12-02	Warnings	Exact identifier application number: M003
First Aid Antiseptic Isopropyl Alcohol Pad	ISOPROPYL ALCOHOL	Fourstar Group USA, Inc.	27edf5dc-3e68-bdd0-e063-6394a90ac485	2024-11-27	Warnings	Exact identifier application number: M003
MicroKlenz Antimicrobial	BENZETHONIUM CHLORIDE	Medline Industries, LP	115dda08-709c-490a-9693-419b51441960	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic Pad	ALCOHOL PAD	Acme United Corporation	55421010-d806-4ca4-e054-00144ff88e88	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Hydrogen Peroxide 3%	HYDROGEN PEROXIDE	Acme United Corporationn	f1db8929-9b95-0d6e-e053-2995a90a817f	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL	Acme United Corporation	d71047f6-1353-c758-e053-2995a90a962c	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic Pad	ISOPROPYL ALCOHOL	Acme United Coporation	a01fec1b-1339-40b9-e053-2995a90aeda5	2024-11-23	Warnings	Exact identifier application number: M003
Med-Nap Sterile Alcohol Prep Pads	ISOPROPYL ALCOHOL	Acme United Corporation	c6eff57b-d537-69c8-e053-2a95a90adc3a	2024-11-23	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic	ISOPROPYL ALCOHOL	Acme United Corporation	a810e723-ad0c-8c71-e053-2995a90a0acc	2024-11-23	Warnings	Exact identifier application number: M003
Universal 50% Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	0dcc9bd2-aea5-4c27-9956-47d56221726b	2024-11-22	Warnings	Exact identifier application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and Glycerin	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	9a9d42ad-79d5-4acc-b5d9-cb7468961d47	2024-11-22	Warnings	Exact identifier application number: M003
Universal 50% Rubbing Alcohol with Wintergreen and Glycerin	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	044a6287-f568-4cfa-a813-7fc0e6ffc352	2024-11-22	Warnings	Exact identifier application number: M003
NEXXGEN 70% RUBBING ALCOHOL	ISOPROPYL ALCOHOL	A & A Nexxgen LLC	ce73ac48-c5af-4a35-950c-62ff0232aa30	2024-11-22	Warnings	Exact identifier application number: M003
Universal 70% Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	d8b9b0e7-2cb8-4fc5-af55-790e64d6cfe8	2024-11-22	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
413246	triclosan 0.2 % Medicated Liquid Soap	PSN	23ff5450-8308-41c0-9052-1ac4c4433d6c	3
413246	triclosan 2 MG/ML Medicated Liquid Soap	SCD	23ff5450-8308-41c0-9052-1ac4c4433d6c	3
413246	triclosan 0.2 % Medicated Liquid Soap	SY	23ff5450-8308-41c0-9052-1ac4c4433d6c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-016-01	57337001601	500 mg in 1 BOTTLE (57337-016-01)	500 mg	2013-07-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Liquid Hand Cleanse	Rejoice International, Inc. \| China Ningbo Shangge Cosmetic Technology Corp.	2024-02-28	HUMAN OTC DRUG LABEL	3