XtraCare Foaming Facial Cleanser

Product NDC: 57337-036
11-digit product format: 573370036
Labeler code: 57337
Product ID: 57337-036_126d79f0-68eb-8a53-e063-6294a90a6fe1
Type: HUMAN OTC DRUG
Nonproprietary name: Triclosan
Dosage form: GEL
Route: TOPICAL
Labeler: Rejoice International
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-11-26
Substance: TRICLOSAN
Active strength: 1 mg/237mg
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 Foaming Facial Cleanser
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRICLOSAN	1 mg/237mg

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313fcd4a-8641-417e-bf0b-02359ad815fe	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-036-01	2024-02-28	C162847	48780-1	1030e365-0263-111a-e063-dadaa90a10e2	XtraCare Foaming Facial Cleanser
57337-036-01	2024-01-30	C162847	48780-1	1030e365-0263-111a-e063-dadaa90a10e2	XtraCare Foaming Facial Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-036-01	XtraCare Foaming Facial Cleanser	237 mg in 1 BOTTLE	GEL	237		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
POLYOXYL 40 CASTOR OIL	INACTIVE INGREDIENT	4ERD2076EF	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-036	XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]	3	Current NDC, Legacy NDC, 1 package rows	20240229_313fcd4a-8641-417e-bf0b-02359ad815fe.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 66 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petrolatum Jelly	PETROLATUM	NEW PRIDE CORP	f6634410-fa1f-7987-e053-2995a90abb06	2023-12-01	Warnings	Exact identifier application number: M016
Cetaphil Cracked Skin Repair Balm	DIMETHICONE	Galderma Laboratories, L.P.	5efb3ef0-6ee9-4ef8-b81e-90bd1825c956	2023-11-30	Warnings	Exact identifier application number: M016
Cetaphil Cracked Skin Repair	DIMETHICONE	Galderma Laboratories, L.P.	27d74e0f-8359-4c59-bf7f-acade7f4545c	2023-11-30	Warnings	Exact identifier application number: M016
Sheffield Advanced Scar Gel	ADVANCED SCAR GEL	Sheffield Pharmaceuticals LLC	ab78b946-81ed-442c-a167-26c26c7fe8a1	2023-11-30	Warnings	Exact identifier application number: M016
Akin Diaper Rash	ZINC OXIDE	Southern Sales & Service, Inc.	f5515517-7977-48f9-aab6-cf0d2f2a04a0	2023-11-29	Warnings	Exact identifier application number: M016
Dr. Sheffield Diaper Rash	ZINC OXIDE	Sheffield Pharmaceuticals LLC	cac77320-b5cf-4edf-9693-ebabfb61390c	2023-11-28	Warnings	Exact identifier application number: M016
Sheffield Zinc Oxide	ZINC OXIDE	Sheffield Pharmaceuticals LLC	60b54c04-4387-4954-951d-165809947310	2023-11-28	Warnings	Exact identifier application number: M016
Cetaphil Baby Soothe and Protect Cream	ALLANTOIN	Galderma Laboratories, L.P.	38254e03-3716-4e45-86b7-06430ebadc86	2023-11-22	Warnings	Exact identifier application number: M016
Cetaphil Baby Eczema Soothing	COLLOIDAL OATMEAL	Galderma Laboratories, L.P.	d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b	2023-11-22	Warnings	Exact identifier application number: M016
EczemaHoneyBodyLotion	COLLOIDAL OATMEAL	Allure Labs	0a710be0-562e-8368-e063-6294a90a3b1b	2023-11-18	Warnings	Exact identifier application number: M016
Zinc Oxide	SKIN PROTECTANT	BluePoint Laboratories	d9b752e6-655a-19a6-e053-2995a90a9a37	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL ORIGINAL PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	47b8c720-ad1e-4ac7-ba73-872e409b38bf	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	1ac9ee69-339d-4426-b3bf-13e5386f1a9b	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	cf888bf3-6950-43aa-b4be-5a32961b4d96	2023-11-15	Warnings	Exact identifier application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	b6e0ddb8-3761-482a-83d0-15d612d142eb	2023-11-15	Warnings	Exact identifier application number: M016
DERMA SANTE Anti Eczema Cream	OATMEAL	Hope Science Inc.	1492a6ad-016c-4307-8286-5c564de9e160	2023-11-11	Warnings	Exact identifier application number: M016
M3 NATURALS Eczema Cream	OATMEAL	M3 Naturals LLC	45e2cdde-58fb-4eea-a54d-f53f9ad0d854	2023-11-11	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy	OATMEAL	THERAPLEX, LLC	53900588-5c9e-4164-816d-017bdbb0f31b	2023-11-11	Warnings	Exact identifier application number: M016
Boudreauxs Butt Diaper Rash Max Strength	ZINC OXIDE	Geodis Logistics LLC	1b4fd6cb-f2dc-40a2-b958-e99caec91793	2023-11-10	Warnings	Exact identifier application number: M016
Boudreauxs Butt Diaper Rash Original	ZINC OXIDE	Geodis Logistics LLC	97587458-4ca0-4de3-9bb9-148346d859c0	2023-11-10	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4NM5039Y5X	TRICLOSAN	3380-34-5	TRICLOSAN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-036-01	57337003601	237 mg in 1 BOTTLE (57337-036-01)	237 mg	2013-11-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Foaming Facial Cleanser	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp.	2024-02-28	HUMAN OTC DRUG LABEL	3