XtraCare Wet Wipes

Product NDC: 57337-062
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 · 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	57337-062-01	`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	57337-062-01	`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	57337-062-01	`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 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 113 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand Sanitizer	ETHYL ALCOHOL	Raining Rose, Inc.	416267f2-85c5-6633-e054-00144ff8d46c	2023-11-03	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	70%ISOPROPYL ALCOHOL	Raya Pharmaceuticals LLC	da108e12-4327-db1c-e053-2a95a90a211b	2023-10-27	Warnings	Exact identifier application number: M003
POVIDONE-IODINE PAD- povidone-iodine swab	POVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)	Raya Pharmaceuticals LLC	dbcbd1be-5274-3de3-e053-2995a90abf1c	2023-10-27	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	4bfea435-f40d-4976-8450-a699f7640c65	2023-10-23	Warnings	Exact identifier application number: M003
Sting Relief	BENZOCAINE, ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	3a32398a-3f7e-4da0-bb1d-b3f369914b2a	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep Pad	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a504b8-b0c0-030a-e054-00144ff88e88	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a504b8-b0af-030a-e054-00144ff88e88	2023-10-23	Warnings	Exact identifier application number: M003
BZK	BENZALKONIUM CHLORIDE	Jianerkang Medical Co., Ltd	d96c6ad2-c7e9-4079-9db2-59d108f284bb	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a5690c-08bf-5092-e054-00144ff8d46c	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a5726f-d314-50d9-e054-00144ff8d46c	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Scrub	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a5690c-08ad-5092-e054-00144ff8d46c	2023-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	1c7f9a00-6600-4b0d-af11-fa776b22e678	2023-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	1c9f2c8b-6ed6-4e54-a151-5be4acb290e4	2023-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	878bfaa7-d553-40db-8311-19010930abd9	2023-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	c1273e40-5c09-435b-adf3-e352fdd01e9e	2023-10-23	Warnings	Exact identifier application number: M003
POVIDONE IODINE SCRUB SWABSTICK 3s	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	65783da9-acca-41c7-860b-1de108edc583	2023-10-23	Warnings	Exact identifier application number: M003
Obstetrical Towelette	BENZALKONIUM CHLORIDE	Jianerkang Medical Co., Ltd	8db4eb14-85b6-4c8e-9623-39a43b3827a1	2023-10-23	Warnings	Exact identifier application number: M003
POVIDONE IODINE PREP PAD Sterile	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	ac3aa401-a124-4eb7-9598-119be0f24ddd	2023-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	c13af96e-f76a-4577-8d57-811ccc652738	2023-10-23	Warnings	Exact identifier application number: M003
Povidone-Iodine Prep Pad	POVIDONE-IODINE	Cardinal Health 200, Inc.	06c8a6f6-2fc8-4292-a3b5-6311a918a521	2023-10-23	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