Berberex Wound Gel

Product NDC: 52261-0601
11-digit product format: 522610601
Labeler code: 52261
Product ID: 52261-0601_67cabb40-44f2-4ad0-ad14-77f4ab2bd1dc
Type: HUMAN OTC DRUG
Nonproprietary name: Benzethonium Chloride, Allantoin
Dosage form: GEL
Route: TOPICAL
Labeler: Cosco International, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-07-01
Substance: BENZETHONIUM CHLORIDE; ALLANTOIN
Active strength: .0012; .005 kg/kg; kg/kg
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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52261-0601-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52261-0601-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52261-0601-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52261-0601-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52261-0601-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52261-0601-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52261-0601-1	U	Excluded because listing certification expired	`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: Berberex Wound Gel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZETHONIUM CHLORIDE	.0012 kg/kg
ALLANTOIN	.005 kg/kg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PH41D05744	Internal UNII lookup
344S277G0Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5dd97e65-bfb3-468e-a2b1-e56d30da99df	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52261-0601-1	2025-03-28	C162847	48780-1	2cef2736-83e1-d83d-e063-dadaa90ab31f	BerbereX Wound Gel - Antimicrobial Skin & Wound Hydrogel
52261-0601-1	2025-01-30	C162847	48780-1	2cef2736-83e1-d83d-e063-dadaa90ab31f	BerbereX Wound Gel - Antimicrobial Skin & Wound Hydrogel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52261-0601-1	Berberex Wound Gel	0.0850 kg in 1 TUBE	GEL	0.0850		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52261-0601	BERBEREX WOUND GEL (BENZETHONIUM CHLORIDE, ALLANTOIN) GEL [COSCO INTERNATIONAL, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20250331_5dd97e65-bfb3-468e-a2b1-e56d30da99df.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 23 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Redicare Alcohol Prep Pads	MEDIUM ALCOHOL PREP PADS	Redicare LLC	3cb7fba1-1d2d-f4da-e063-6394a90a4b21	2026-05-01	Warnings	Exact identifier application number: M003
SCOTT Antiseptic Foam Skin Cleanser	CHLOROXYLENOL	Kimberly-Clark	ca761935-7dcc-4caf-b941-60693a97c8a6	2026-04-30	Warnings	Exact identifier application number: M003
SCOTT FOAM HAND SANITIZER	BENZALKONIUM CHLORIDE	Kimberly-Clark	11234f21-04e4-4b16-88c3-51968a1cedca	2026-04-30	Warnings	Exact identifier application number: M003
First Aid Antiseptic	POVIDONE-IODINE	Retail Business Services, LLC	ad4e49b6-5784-4880-950b-6e6175fc312b	2026-04-30	Warnings, Adverse reactions	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Your Military Exchanges	3dcb8422-827d-479b-ba18-eee8dbb762e1	2026-04-30	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Target Corporation	33591569-8c56-4721-9d14-d9696f93c793	2026-04-30	Warnings, Adverse reactions	Exact identifier application number: M003
Oopsie 3 Hydrogen Peroxide	HYDROGEN PEROXIDE	4 Visions LLC	50b0d82a-da2c-5fd0-e063-6294a90aa165	2026-04-30	Warnings	Exact identifier application number: M003
Vita Vie Antibacterial Wash	BENZALKONIUM CHLORIDE	Spa De Soleil	a83883b7-9b63-641b-e053-2995a90ab943	2026-04-30	Warnings	Exact identifier application number: M003
Dr Lift Advanced Antibacterial Wipes	BENZALKONIUM CHLORIDE	Spa de Soleil	af89bd25-784e-4828-e053-2995a90a8aaa	2026-04-30	Warnings	Exact identifier application number: M003
Dr Lift Antibacterial Hand Wash	BENZALKONIUM CHLORIDE	Spa de Soleil	ab9e2c3c-d422-255e-e053-2a95a90a7a22	2026-04-30	Warnings	Exact identifier application number: M003
Dr Lift Antibacterial Body Scrub	BENZALKONIUM CHLORIDE	Spa de Soleil	ab9d6c73-29c1-036a-e053-2995a90a449c	2026-04-30	Warnings	Exact identifier application number: M003
KLEENEX Foam Hand Sanitizer	BENZALKONIUM CHLORIDE	Kimberly-Clark	1fa77ae2-b652-463d-8943-d338c591226e	2026-04-29	Warnings	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ETHYL ALCOHOL	Your Military Exchanges	3dce175c-f893-4cfc-b495-6c11f2b77b87	2026-04-29	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Retail Business Services, LLC	2cc09239-a1d4-4276-adc4-82fdc396e23a	2026-04-29	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Perrigo Direct, Inc	11d89d11-103e-4ef6-a996-65cff67f9b32	2026-04-29	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Walmart Inc.	1fd3d29f-7da0-c5ba-e063-6294a90add16	2026-04-29	Warnings, Adverse reactions	Exact identifier application number: M003
Ethyl Alcohol	ETHYL ALCOHOL	Walmart Inc.	1fd3bed0-8fcc-2cee-e063-6294a90a34fb	2026-04-29	Warnings, Adverse reactions	Exact identifier application number: M003
1438 DynaSoap	ANTIBACTERIAL HAND SOAP	Dynarex Corporation	ab0d5f64-9168-2ea3-e053-2a95a90a321e	2026-04-29	Warnings	Exact identifier application number: M003
SCOTT Antimicrobial Foam Skin Cleanser	BENZALKONIUM CHLORIDE	Kimberly-Clark	210f7da3-63c5-4a4b-8db0-8d6d1663751d	2026-04-28	Warnings	Exact identifier application number: M003
anzoon ANTISEPTIC WIPES	BENZETHONIUM CHLORIDE/BENZALKONIUM CHLORIDE	Shandong ACZ Biotechnology Co., Ltd.	506cd089-f9a7-d9e5-e063-6394a90af696	2026-04-27	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
344S277G0Z	ALLANTOIN	97-59-6	ALLANTOIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52261-0601-1	52261060101	.085 kg in 1 TUBE (52261-0601-1)	2022-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BerbereX Wound Gel - Antimicrobial Skin & Wound Hydrogel	Cosco International, Inc.	2025-03-28	HUMAN OTC DRUG LABEL	3