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 38 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Big Lots Stores, Inc.	2c941c08-929c-43c9-966b-279086afca96	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Big Lots Stores, Inc.	2ef87a8a-58be-4123-ad03-9891e6916f1a	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Cardinal Health, 110 dba Leader	d1418649-9490-4dab-b89c-9de6bb719642	2026-01-29	Warnings	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ETHYL ALCOHOL	Cardinal Health, 110 dba Leader	c56cbcbf-8e0e-4dff-80d3-df420c500a93	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Cariba International	001c1fcf-2808-467c-86d8-c038513fa3b5	2026-01-29	Warnings	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Cariba International	483586f4-aab4-40c2-8925-c4f7fb22c6aa	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Cariba International	2c48f58a-a2d1-4a28-8dbf-a9d2c620bca6	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
New Skin Bandage	BENZETHONIUM CHLORIDE	Advantice Health, LLC	60996119-8367-4e22-b6ec-c36490635fa4	2026-01-28	Warnings	Exact identifier application number: M003
BZK Pads	BENZALKONIUM CHLORIDE	Dynarex Corporation	1409c437-ff17-481d-94be-87dd6d463ba9	2026-01-28	Warnings	Exact identifier application number: M003
Singular Wipes Unscented	ISOPROPYL ALCOHOL	SINGULAR ENTERPRISES LLC	ac2b352f-6cb2-4683-bb41-13e8ecb186bf	2026-01-27	Warnings	Exact identifier application number: M003
Singular Wipes fresh Citrus Scent	ALCOHOL	SINGULAR ENTERPRISES LLC	867a25d2-3d2c-4dad-bbe8-84195c03a87d	2026-01-27	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4906f079-8c9f-e3b0-e063-6294a90ad0f8	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4912b681-e21a-1ddf-e063-6294a90aa9f4	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491a6d77-8a84-c76d-e063-6394a90ac61f	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491b55ca-2c7a-0eb7-e063-6394a90a9cb7	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491c4af8-c699-7128-e063-6294a90ae0f9	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491de8ca-07e7-0aa3-e063-6394a90ae36f	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	492793db-7dc2-8313-e063-6394a90a52bf	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4928615e-d1a9-72b8-e063-6394a90aa7ed	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4943e51a-bb8e-745a-e063-6294a90a0a3d	2026-01-26	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