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 97 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alcohol sterile	ISOPROPYL ALCOHOL	Cardinal Health, Inc	bb7c530f-5d80-4158-b715-09c1c837299d	2024-11-21	Warnings	Exact identifier application number: M003
Alcohol sterile	ISOPROPYL ALCOHOL	Cardinal Health 200 LLC	10135db9-f614-4511-96ac-faa6a02a1b61	2024-11-21	Warnings	Exact identifier application number: M003
BZK Antiseptic Swabsticks 4 Triple	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	d9f35c14-2f5a-4e1a-bc2b-a7e163134213	2024-11-21	Warnings	Exact identifier application number: M003
Povidone-lodine Swabsticks Triple	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	74e70ea9-640b-4295-a40f-56f65fca1300	2024-11-21	Warnings	Exact identifier application number: M003
MK Alcohol Prep Pads Medium	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	37f10b1f-b73c-4d71-91c2-1252f3d9d4ce	2024-11-21	Warnings	Exact identifier application number: M003
BZK Antiseptic Towelette	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	1936d749-bf38-a433-e063-6294a90aba8c	2024-11-21	Warnings	Exact identifier application number: M003
Maokang 10 Povidone Iodine	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	7c17ce40-0358-44ff-aa60-53711666914b	2024-11-21	Warnings	Exact identifier application number: M003
MK Alcohol Prep Pads Medium	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	11390854-9e72-40a2-9c89-3c29a585dced	2024-11-21	Warnings	Exact identifier application number: M003
Instant Hand Sanitizeing Wipe	ISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTS	Shandong Yayun Sanitary Products Co., Ltd.	aa0dc01a-2c6b-7402-e053-2a95a90af6a2	2024-11-21	Warnings	Exact identifier application number: M003
Dynarex Povidone Iodine Prep Solution	POVIDONE IODINE PREP SOLUTION	Dynarex Corporation	6bb4d55b-2be7-3549-e053-2a91aa0a2bb0	2024-11-20	Warnings	Exact identifier application number: M003
Dynarex Povidone Iodine Surgical Scrub	POVIDONE IODINE SURGICAL SCRUB SOLUTION	Dynarex Corporation	6f053e55-cbf6-9072-e053-2991aa0a2edd	2024-11-20	Warnings	Exact identifier application number: M003
Dynarex Green	ALCOHOL	Dynarex Corporation	072572be-49dd-4594-bc40-b56db57ada5b	2024-11-20	Warnings	Exact identifier application number: M003
Dynarex Green	CHLOROXYLENOL	Dynarex Corporation	59b098d2-08de-4fdb-a209-ae226abf37d6	2024-11-20	Warnings	Exact identifier application number: M003
Baby Wipes	PROPYLENE GLYCOL	Shandong Yayun Sanitary Products Co., Ltd.	aeb9a12c-955f-5030-e053-2995a90a2dd6	2024-11-20	Warnings	Exact identifier application number: M003
Pet wipes	BENZALKONIUM CHLORIDE	Shandong Yayun Sanitary Products Co., Ltd.	2764ea79-32d8-b7f6-e063-6394a90a5501	2024-11-20	Warnings	Exact identifier application number: M003
Premium Hand Sanitizer	ETHANOL	MCKESSON MEDICAL-SURGICAL INC.	a9514466-e0c6-4792-984a-9f07d94ee887	2024-11-18	Warnings	Exact identifier application number: M003
MARVEL BZK ANTISEPTIC WIPE	BENZALKONIUM CHLORIDE	Ashtel Studios, Inc.	93ed0bb4-834d-44ca-9c0a-20086fc09ab8	2024-11-18	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	McKesson Medical-Surgical Inc.	98b0bcc2-539b-4471-ba98-bbe17bb881bd	2024-11-15	Warnings	Exact identifier application number: M003
CVS Health Hydrogen Peroxide Wipes	HYDROGEN PEROXIDE	CVS PHARMACY, INC	7a930a5e-5b69-428f-9cbb-d03dae180295	2024-11-12	Warnings	Exact identifier application number: M003
First Aid Only Povidone-Iodine Prep Pad	POVIDONE-IODINE	Acme United Corporation	509b6c8e-6a9f-2656-e054-00144ff8d46c	2024-11-09	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