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 53 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vitamin A D	PETROLATUM	Dynarex Corporation	62ad33f6-46e6-435f-9a5f-e116c3e218bf	2024-11-20	Warnings	Exact identifier application number: M016
Desitin Maximum Strength Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	af64fc2f-c027-4a68-b368-ee06744a2452	2024-11-15	Warnings	Exact identifier application number: M016
Desitin Maximum Strength Zinc Oxide Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	1d5f0207-26f9-2b19-e063-6294a90a6468	2024-11-14	Warnings	Exact identifier application number: M016
Desitin Maximum Strength Zinc Oxide Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	59728810-4ea9-45a1-b945-5a54199e01f3	2024-11-14	Warnings	Exact identifier application number: M016
Johnsons Baby Care Essentials Gift Set	ZINC OXIDE	Kenvue Brands LLC	afa1ba48-b504-4af0-a9c7-cd2c9a2e6e59	2024-11-13	Warnings	Exact identifier application number: M016
70% ISOPROPYL RUBBING ALCOHOL	ISOPROPYL ALCOHOL	MY IMPORTS USA LLC	26cbc1af-a38f-146b-e063-6394a90a716c	2024-11-13	Warnings	Exact identifier application number: M016
VITAMIN A and D	VITAMIN A AND D	ALLIED TRADE LINK LLC	26d426c3-4dfb-c984-e063-6394a90a3793	2024-11-13	Warnings	Exact identifier application number: M016
ZO Skin Health Post Procedure Program	ALUMINUM ACETATE	ZO Skin Health, Inc.	9786acc8-06ae-4f2b-9602-b7e8c3baeca5	2024-11-12	Warnings	Exact identifier application number: M016
DUKAL WHITE PETROLATUM	PETROLATUM	Dukal LLC	0c6474ed-2343-d5f2-e063-6394a90a30b3	2024-11-12	Warnings	Exact identifier application number: M016
CVS Health Advanced Scar Gel	ADVANCED SCAR GEL	CVS Health	2fead2d8-b645-4d45-8e5b-b4f1da4e5a25	2024-11-12	Warnings	Exact identifier application number: M016
CVS Health Advanced Scar Gel	ADVANCED SCAR GEL	CVS Health	c6926594-ad4e-4937-bda2-9311219a8881	2024-11-12	Warnings	Exact identifier application number: M016
CVS Zinc Oxide	ZINC OXIDE	CVS Health	d67533b1-ae3f-4c9a-a6c9-a742290c90e9	2024-11-11	Warnings	Exact identifier application number: M016
CVS Eczema Relief Skin Protectant	OATMEAL	CVS Health	3cf25c43-592f-41cb-aa0b-a82f4e7faf3d	2024-11-11	Warnings	Exact identifier application number: M016
DGH Advanced Formula Scar Skin Protectant	ALLANTOIN	Dolgencorp Inc	950dcffd-d2c3-4ca7-8a15-7cb1016ca364	2024-11-08	Warnings	Exact identifier application number: M016
ABC Arbonne Baby Care Diaper Rash	DIMETHICONE AND ZINC OXIDE	Arbonne International, LLC	dd1d8198-bb9d-4508-a971-ae3bc624cdd1	2024-11-08	Warnings	Exact identifier application number: M016
SUPER SENSITIVE DIAPER RASH	ZINC OXIDE	ORGANIC & SUSTAINABLE BEAUTY	b0de2a9b-7854-4caf-b7ff-632c1d4a382e	2024-11-08	Warnings	Exact identifier application number: M016
Dove	DERMASERIES ECZEMA RELIEF SOOTHING BODY LOTION	Conopco, Inc. d/b/a/ Unilever	bcfb12ea-304e-7d8c-e053-2a95a90af606	2024-11-07	Warnings	Exact identifier application number: M016
Vaseline	CLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAM	Conopco, Inc. d/b/a/ Unilever	bd206830-e334-3764-e053-2995a90a74ca	2024-11-07	Warnings	Exact identifier application number: M016
Dove	MEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BAR	Conopco Inc. d/b/a/ Unilever	b9e61a03-e000-50ab-e053-2a95a90a3210	2024-11-07	Warnings	Exact identifier application number: M016
Dove	DOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASH	Conopco Inc. d/b/a/ Unilever	b9f8cb31-560c-79e0-e053-2a95a90a39ae	2024-11-07	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