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…`

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: 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 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	e9a9fc7c-31da-ea3f-e053-2a95a90a0eab	2026-09-09	Warnings	Exact identifier application number: M003
Alcohol Prep Pad Medium	ALCOHOL PREP PAD	Yangzhou Huanrui Medical Technology Co., Ltd	5af3eedc-d01e-c9e9-e063-6394a90a49e1	2026-09-08	Warnings	Exact identifier application number: M003
Henry Schein Povidone-Iodine Prep Pad	POVIDONE-IODINE	Henry Schein, Inc.	313416b8-60b2-4a77-9b56-5c507aae9072	2026-09-08	Warnings	Exact identifier application number: M003
Verifine	ALCOHOL SWABS	Promisemed Hangzhou Meditech Co., LTD	5af9f31b-0c92-e3a9-e063-6394a90a38c9	2026-09-08	Warnings	Exact identifier application number: M003
Verifine	ALCOHOL SWABS	Promisemed Hangzhou Meditech Co., LTD	5afc0201-490e-ccf3-e063-6394a90aadad	2026-09-08	Warnings	Exact identifier application number: M003
Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL CLOTH	JINHUA JINGDI MEDICAL SUPPLIES CO., LTD	57ccc28b-5f5f-30ec-e063-6294a90a081c	2026-09-07	Warnings	Exact identifier application number: M003
hand sanitizer - cherry sundae	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	270d2ce0-6310-4a84-be8a-72db6062bae7	2026-09-07	Warnings	Exact identifier application number: M003
hand sanitizer - vanilla frosting	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	f6cabda2-6e1c-4238-9a2e-df10e263517d	2026-09-07	Warnings	Exact identifier application number: M003
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggets	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	ba3612b3-9696-417a-ba66-eb9dc5ea27c6	2026-09-07	Warnings	Exact identifier application number: M003
hydrating mist hand sanitizer with silicone keychain holder - signature scent	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	5b0ac694-66e0-437f-86cd-09f259344b89	2026-09-07	Warnings	Exact identifier application number: M003
Sweethearts - Crush On You - Peach Skin	ALCOHOL	Scent Theory Products LLC	5ac32582-d888-edf4-e063-6394a90a40ab	2026-09-05	Warnings	Exact identifier application number: M003
Sweethearts - Be Mine - Sugared Berries	ALCOHOL	Scent Theory Products LLC	5ac32ffb-926a-f249-e063-6394a90a8d87	2026-09-05	Warnings	Exact identifier application number: M003
Sweethearts - UR Sweet - Sweet Cherry Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	5ac33b21-9192-8baa-e063-6294a90a6e75	2026-09-05	Warnings	Exact identifier application number: M003
Sweethearts - Ooo La La - Banana Cream Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	5ac34dda-fbdf-0ca7-e063-6394a90ab764	2026-09-05	Warnings	Exact identifier application number: M003
SurviveX PREP WIPES	ALCOHOL PREP PAD	Changzhou Maokang Medical Products Co., Ltd.	5a7e9dc6-cf43-7ffc-e063-6394a90a3faa	2026-09-04	Warnings	Exact identifier application number: M003
Members Mark	ISOPROPYL ALCOHOL	Sams West Inc	c251ac50-f74f-4a48-e053-2a95a90aac0d	2026-09-04	Warnings	Exact identifier application number: M003
Walmart	ISOPROPYL ALCOHOL	Walmart, Inc.	2f1342ef-1843-40a6-e063-6294a90a577f	2026-09-04	Warnings	Exact identifier application number: M003
Curad Alcohol Prep Pads Medium	ISOPROPYL ALCOHOL	Medline Industries, LP	1ce3872e-2307-4a38-bd7d-7eb2b226cf3c	2026-09-04	Warnings	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	SuperValu, Inc.	5e6e6d6f-4472-40f1-b0a9-96cee7ef075b	2026-09-04	Warnings	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	Foodhold U.S.A. LLC	a94c023c-5313-4940-90a7-b3061a8b90e1	2026-09-04	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