XtraCare Wet Wipes

Product NDC: 57337-062
Requested package NDC: 57337-062-01
11-digit product format: 573370062
Labeler code: 57337
Product ID: 57337-062_2decd513-1fc5-1793-e063-6294a90a18bf
Type: HUMAN OTC DRUG
Nonproprietary name: Benzethonium Chloride
Dosage form: SWAB
Route: TOPICAL
Labeler: Rejoice International
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-03-13
Substance: BENZETHONIUM CHLORIDE
Active strength: 3 mg/100mg
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 · 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	57337-062	57337-062-01	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	57337-062	57337-062-01	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	57337-062	57337-062-01	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 Wet Wipes
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZETHONIUM CHLORIDE	3 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PH41D05744	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043348	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
3741acc3-c590-4bf1-8c83-4f812e2c7adc	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-062-01	2025-02-12	C162847	48780-1	2cef2736-8c1d-d83d-e063-dadaa90ab31f	XtraCare Wet Wipes
57337-062-01	2025-01-30	C162847	48780-1	2cef2736-8c1d-d83d-e063-dadaa90ab31f	XtraCare Wet Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-062-01	XtraCare Wet Wipes	100 mg in 1 APPLICATOR	SWAB	100		3
57337-062-01	XtraCare Wet Wipes	18 in 1 PACKAGE	SWAB	18		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZETHONIUM CHLORIDE	ACTIVE INGREDIENT	PH41D05744	XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [REJOICE INTERNATIONAL]	1
BENZETHONIUM	ACTIVE MOIETY	1VU15B70BP	XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [REJOICE INTERNATIONAL]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [REJOICE INTERNATIONAL]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [REJOICE INTERNATIONAL]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [REJOICE INTERNATIONAL]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [REJOICE INTERNATIONAL]	1
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [REJOICE INTERNATIONAL]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [REJOICE INTERNATIONAL]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [REJOICE INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [REJOICE INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-062	XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [REJOICE INTERNATIONAL]	3	Current NDC, Legacy NDC, 2 package rows	20250214_3741acc3-c590-4bf1-8c83-4f812e2c7adc.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 102 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
STRAWBERRY SHORTCAKE SCENTED HAND SANITIZER	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	997d0ff0-96b4-4b91-87fc-8f67d9b5013c	2024-08-28	Warnings	Exact identifier application number: M003
hand sanitizer 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	202dfeac-6e69-8667-e063-6294a90a26d2	2024-08-21	Warnings	Exact identifier application number: M003
antibacterial hand sanitizer gel 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	202e5c15-8749-0a76-e063-6294a90a2720	2024-08-21	Warnings	Exact identifier application number: M003
Be Smart Get Prepared Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS	Total Resources International, Inc	eacb5138-4af8-4550-b883-5603ad96ed7d	2024-08-16	Warnings	Exact identifier application number: M003
First Aid Only Povidone-Iodine Antiseptic	POVIDONE-IODINE	Acme United Corporation	e0052ac2-4f74-32a4-e053-2995a90a94c6	2024-08-13	Warnings	Exact identifier application number: M003
Keep Going Sting Relief Pad	BENZOCAINE AND ISOPROPYL ALCOHOL	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	36c11178-b70f-4355-8823-c2b72598dae5	2024-08-08	Warnings	Exact identifier application number: M003
Keep Going Non Sting Cleaning Wipe	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	6b7400d5-d4b8-4b68-b048-c1917cdf3ce3	2024-08-08	Warnings	Exact identifier application number: M003
Keep Going Alcohol Prep Pad	ISOPROPYL ALCOHOL	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	f67dd10c-746f-4c21-92f1-741f86218a69	2024-08-08	Warnings	Exact identifier application number: M003
Sugar Cookie Sanitizer 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1efc0e9e-b4eb-d2b0-e063-6394a90a7779	2024-08-06	Warnings	Exact identifier application number: M003
Lemon Lime Hand Sanitizer Spray. 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1efe7236-d7bd-2a1c-e063-6294a90a736e	2024-08-06	Warnings	Exact identifier application number: M003
Maokang Medical 10 Povidone Iodine	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	644e92c3-3043-4a76-9845-7e0482cf9f62	2024-07-19	Warnings	Exact identifier application number: M003
Dermal Wound Cleanser	BENZETHONIUM CHLORIDE	Smith & Nephew Medical Ltd.	18704cd5-1ecf-4e8c-9897-7e45394e68c8	2024-07-15	Warnings	Exact identifier application number: M003
Novex Anti-Bacterial Hand Sanitizer Wipe	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	7832a0be-a8ce-4b56-a9bb-a375b97df287	2024-07-10	Warnings	Exact identifier application number: M003
Callington Anti-Bacterial Hand Sanitizer Wipe	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	00ca48ca-893d-4a3f-ad90-119522664e08	2024-07-10	Warnings	Exact identifier application number: M003
Assorted Licensed Hand Sanitizer Grape 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1c9095ad-ce19-3666-e063-6394a90ae22d	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccb78ed-36f9-a7d2-e063-6394a90a6477	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccb9671-1970-39f9-e063-6294a90ac079	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccbc68e-2b6b-768c-e063-6294a90a643b	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccbbc55-3f7d-76d1-e063-6294a90a5590	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	1cb701f7-61c8-e5f4-e063-6294a90a0c3c	2024-07-08	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PH41D05744	BENZETHONIUM CHLORIDE	121-54-0	BENZETHONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043348	benzethonium Cl 0.3 % Medicated Pad	PSN	3741acc3-c590-4bf1-8c83-4f812e2c7adc	3
1043348	benzethonium chloride 3 MG/ML Medicated Pad	SCD	3741acc3-c590-4bf1-8c83-4f812e2c7adc	3
1043348	benzethonium chloride 0.3 % Medicated Wipe	SY	3741acc3-c590-4bf1-8c83-4f812e2c7adc	3
1043348	benzethonium chloride 0.3 % Topical Cloth	SY	3741acc3-c590-4bf1-8c83-4f812e2c7adc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-062-01	57337006201	18 APPLICATOR in 1 PACKAGE (57337-062-01) / 100 mg in 1 APPLICATOR	18 applicator	2014-03-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Wet Wipes	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp	2025-02-12	HUMAN OTC DRUG LABEL	3