XtraCare Antibacterial Hand Cleanse

Product NDC: 57337-069
Requested package NDC: 57337-069-01
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: 2026-12-31
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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57337-069	57337-069-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57337-069	57337-069-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57337-069	57337-069-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Additional Listing Data#

Finished product: Yes
Brand name base: XtraCare Antibacterial Hand Cleanse
Brand name suffix: Fresh Citrus
Listing expiration: 2026-12-31

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 1 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIOPURE50CT ANTI BACTERIAL HAND WIPES	BIOPURE50CT ANTI BACTERIAL HAND WIPES	Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd	57d3e290-1343-4075-e063-6394a90a41a6	2026-07-30	Warnings	Exact identifier application number: M003
Meridian Unwrapped antibacterial deodorant	BENZETHONIUM CHLORIDE	Bob Barker Company Inc.	c2d13d97-99ce-4a24-bdd6-684fbbf242a4	2026-07-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 4pk - Fresh Gingerbread/Spiced Cranberry/Vanilla Heaven/Pistachio Brulee	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57bd148e-f9eb-dfb6-e063-6394a90a1e12	2026-07-29	Warnings	Exact identifier application number: M003
School Health	ISOPROPYL ALCOHOL	School Health Corporation	db5d0b22-f2d7-23e5-e053-2a95a90aeb51	2026-07-29	Warnings	Exact identifier application number: M003
Jelly Smack	BENZALKONIUM CHLORIDE	VULCAN MICROBIAL CORPORATION	eb79e11a-6c29-556b-e053-2a95a90a728a	2026-07-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 4pk - Fresh Calming Lavender/Sweet Citrus/Coconut Breeze/ Cucumber Melon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57cb54f7-07be-524f-e063-6294a90a2c94	2026-07-29	Warnings	Exact identifier application number: M003
Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL CLOTH	JINHUA JINGDI MEDICAL SUPPLIES CO., LTD	57ccc28b-5f5f-30ec-e063-6294a90a081c	2026-07-29	Warnings	Exact identifier application number: M003
Meridian wrapped antibacterial deodorant	BENZETHONIUM CHLORIDE	Bob Barker Company Inc.	de60d4d5-87bc-4400-94e2-8307a9bb0870	2026-07-29	Warnings	Exact identifier application number: M003
70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	4 Visions	57ac6fef-21de-e214-e063-6394a90a6c9e	2026-07-28	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	4 Visions LLC	57acc1ff-2564-1e61-e063-6394a90a3c91	2026-07-28	Warnings	Exact identifier application number: M003
It Bag Vanilla Sugar Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	57adcf08-9785-016d-e063-6294a90aa8d4	2026-07-28	Warnings	Exact identifier application number: M003
It Bag Cherry Kiss Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	57adec54-6099-0694-e063-6394a90a4a0f	2026-07-28	Warnings	Exact identifier application number: M003
It Bag Strawberry Love Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	57adfb22-cb7a-39e7-e063-6294a90a3079	2026-07-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer with Pouch-Cherry Blossom	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57b6f063-9afa-94c9-e063-6394a90a2c35	2026-07-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Lavender Vanilla	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57b7250c-49cd-3076-e063-6294a90ab757	2026-07-28	Warnings	Exact identifier application number: M003
Magicare alcohol hand sanitizing wipes	ALCOHOL HAND SANITIZING WIPES	Guangzhou Baihua Co., Ltd	57b7531b-77f7-f63b-e063-6394a90aa81c	2026-07-28	Warnings	Exact identifier application number: M003
Magicare alcohol hand sanitizing wipes	ALCOHOL HAND SANITIZING WIPES	Guangzhou Baihua Co., Ltd	57b7b74e-6df9-4384-e063-6394a90a09c4	2026-07-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Fig Vanilla	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57b7b91f-1874-f2f0-e063-6294a90a4060	2026-07-28	Warnings	Exact identifier application number: M003
Walgreens Hand Sanitizer Vanilla	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57b7f5fd-0472-3a84-e063-6294a90adb9e	2026-07-28	Warnings	Exact identifier application number: M003
Liquid Bandage	BENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDE	Meijer Distribution Inc	036fd504-0cda-60ab-e063-6394a90a2f18	2026-07-27	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