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 95 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OPS RANCH HAND ANTIBACTERIAL FOAMING	CHLOROXYLENOL	Archer Manufacturing, Inc.	d8187090-8423-062e-e053-2a95a90aad18	2024-12-05	Warnings	Exact identifier application number: M003
BLACK OPS AB ANTIBACTERIAL FOAMING	BENZALKONIUM CHLORIDE	Archer Manufacturing, Inc.	d335bf6d-dc75-bd80-e053-2a95a90abb56	2024-12-05	Warnings	Exact identifier application number: M003
OPS INSTANT HAND SANITIZER	BENZALKONIUM CHLORIDE	Archer Manufacturing, Inc.	d4c65a93-832a-6a8b-e053-2a95a90a77b8	2024-12-05	Warnings	Exact identifier application number: M003
alcohol pad 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	03a6e8d4-535d-b316-e063-6294a90aebf5	2024-12-04	Warnings	Exact identifier application number: M003
antiseptic towelette 01	BENZALKONIUM CHLORIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e9f2a1f1-ceb6-2f20-e053-2a95a90a18db	2024-12-04	Warnings	Exact identifier application number: M003
BobBarker antibacterial wrapped body	BENZETHONIUM CHLORIDE	Yangzhou H&R Plastic Daily Chemical Co., Ltd.	208b37b4-cfc3-4bf1-adc1-96d4b1d2cfa5	2024-12-04	Warnings	Exact identifier application number: M003
Walgreens 70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	Walgreen Co.	21f125a0-73e8-34a9-e063-6294a90a8396	2024-12-04	Warnings	Exact identifier application number: M003
Emory Johns Creek Amenity	ALCOHOL AND SODIUM MONOFLUOROPHOSPATE	ASP Global	952ccb85-71bb-4d5d-ac9b-62851a39d36d	2024-12-04	Warnings	Exact identifier application number: M003
Watermelon Hand Sanitizer Spray. 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1f0f9885-2ad5-09de-e063-6394a90ad0d7	2024-12-03	Warnings	Exact identifier application number: M003
Foster and Thrive Povidone-Iodine	POVIDONE IODINE	Strategic Sourcing Services, LLC	28621f29-ce45-c6dc-e063-6294a90aa5f7	2024-12-03	Warnings	Exact identifier application number: M003
Sanitizing Hand Mist Unscented	ETHYL ALCOHOL	ALO New York LLC	e194daee-2197-4718-e053-2a95a90a4890	2024-12-03	Warnings	Exact identifier application number: M003
Instant Hand Antiseptic	ALCOHOL	ASP Global	291eaa18-81f8-6907-e054-00144ff88e88	2024-12-03	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Passion Berrys	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	aee5d7c2-93b3-f55e-e053-2995a90af72e	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Fresh and Relax	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d3086-7902-2837-e053-2995a90a39df	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Grapefruit	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d4c11-1f49-06c4-e053-2995a90a1e48	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Red Fruits	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d4c11-1f4d-06c4-e053-2995a90a1e48	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Oatmeal	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e1c5f6-195c-16d6-e063-6394a90abb86	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Instant Hand Sanitizer	ETHYL ALCOHOL 70%	Industria La Popular, S.A.	b2e4d58d-adff-3cb2-e053-2995a90a392e	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Fresh Energy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e2289d-60f4-260c-e063-6394a90a96f6	2024-12-02	Warnings	Exact identifier application number: M003
Jabonito Kids Green Apple Liquid	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	021bc525-3ebe-efc2-e063-6394a90a3fe3	2024-12-02	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