XtraCare Antibacterial Hand Cleanse

Product NDC: 57337-069
11-digit product format: 573370069
Labeler code: 57337
Product ID: 57337-069_2decfde9-cfb3-3dbb-e063-6294a90aac46
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: 2013-09-03
Substance: TRICLOSAN
Active strength: 3.3 mg/221mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57337-069-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57337-069-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57337-069-01	`0efc9e666f02…`	`f202fb6c5f17…`

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: Fresh Citrus
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
e87ef6e6-ef41-43c4-bfdf-b7e3446436b7	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-069-01	2025-02-12	C162847	48780-1	2cef2736-a759-d83d-e063-dadaa90ab31f	XtraCare Antibacterial Hand Cleanse
57337-069-01	2025-01-30	C162847	48780-1	2cef2736-a759-d83d-e063-dadaa90ab31f	XtraCare Antibacterial Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-069-01	XtraCare Antibacterial Hand CleanseFresh Citrus	221 mL in 1 BOTTLE	SOAP	221		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-069	XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20250214_e87ef6e6-ef41-43c4-bfdf-b7e3446436b7.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 12 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink Sugar	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	55fd1844-bfeb-c0ef-e063-6294a90a4492	2026-07-06	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared Plum	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	559a9300-964e-ea9a-e063-6394a90a4016	2026-07-02	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Sea Salt Air	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	559a5f07-1557-c6d6-e063-6394a90a832f	2026-07-02	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber Glow	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	55242d92-04af-0224-e063-6394a90aee98	2026-07-02	Warnings	Exact identifier application number: M003
BAK 1 750	BENZALKONIUM CHLORIDE	Medical Chemical Corporation	d1f06aa6-2264-4ac1-a9a4-8ca9be1c9ca8	2026-07-02	Warnings	Exact identifier application number: M003
HYDROGEN PEROXIDE	HYDROGEN PEROXIDE	Medical Chemical Corporation	b1ce5858-36fe-70dc-e053-2995a90a5913	2026-07-02	Warnings	Exact identifier application number: M003
HYDROGEN PEROXIDE	HYDROGEN PEROXIDE	Medical Chemical Corporation	f6d677b8-fa89-4efb-984a-fd98e3e590e8	2026-07-02	Warnings	Exact identifier application number: M003
American Red Cross IPA 50% 6oz	AMERICAN RED CROSS IPA 50% 6OZ	TSM BRANDS LLC	29195bac-b096-ab8d-e063-6394a90a424a	2026-07-01	Warnings	Exact identifier application number: M003
American Red Cross 6oz, 50% Isopropyl Alcohol	AMERICAN RED CROSS 6 OZ, 50% ISOPROPYL ALCOHOL SPRAY	MY IMPORTS USA LLC	2929d580-cfff-e2b6-e063-6394a90a79aa	2026-07-01	Warnings	Exact identifier application number: M003
Medi Fect Antiseptic Hand Wash	ETHYL ALCOHOL	Medical Chemical Corporation	dc397d9c-9c12-41e5-ab7f-196fcad5bf97	2026-07-01	Warnings	Exact identifier application number: M003
AloeSafe Antiseptic Hand Sanitizer	ETHYL ALCOHOL	Medical Chemical Corporation	950f012e-7908-523c-e053-2995a90afa6b	2026-07-01	Warnings	Exact identifier application number: M003
Compound Benzoin Tincture	TINCTURE OF BENZOIN	Medical Chemical Corporation	243494ee-342d-4c32-9a86-f8c6c347bd8b	2026-07-01	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach Sandalwood	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	55984504-188f-13bc-e063-6394a90a9150	2026-07-01	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber Glow	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5597ed5f-ed98-ebeb-e063-6294a90a2e8d	2026-07-01	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry Creme	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5598c831-3986-00a5-e063-6394a90a1e66	2026-07-01	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple Splash	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	55982f73-7baa-26a7-e063-6394a90ab74b	2026-07-01	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry Crumble	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	55981d2a-d4de-af08-e063-6294a90a4b7c	2026-07-01	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti Cupcake	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5597ff1f-b134-0beb-e063-6394a90a39a1	2026-07-01	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread Cake	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5598d6ca-39f6-ca2a-e063-6394a90abc0e	2026-07-01	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha Mist	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	559832ca-df92-0c2d-e063-6294a90ab66f	2026-07-01	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	e87ef6e6-ef41-43c4-bfdf-b7e3446436b7	3
1020118	triclosan 1.5 MG/ML Medicated Liquid Soap	SCD	e87ef6e6-ef41-43c4-bfdf-b7e3446436b7	3
1020118	triclosan 0.15 % Medicated Liquid Soap	SY	e87ef6e6-ef41-43c4-bfdf-b7e3446436b7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-069-01	57337006901	221 mL in 1 BOTTLE (57337-069-01)	221 ml	2013-09-03	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.	2025-02-12	HUMAN OTC DRUG LABEL	3