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 41 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzalkonium Chloride	SANITIZING HAND WIPES	ALO NEW YORK LLC	d3afde78-b9f6-3648-e053-2a95a90a4024	2026-01-15	Warnings	Exact identifier application number: M003
BIOPURE Hand Sanitizer Spray-Coastal Glow	HAND SANITIZER SPRAY	Quest USA Corp	48254577-9f1e-9389-e063-6394a90a92f1	2026-01-15	Warnings	Exact identifier application number: M003
hi peach layne	ETHYL ALCOHOL	Zhejiang Jinghui Cosmetics Share Co., Ltd.	487a4c8e-4fb3-6bff-e063-6294a90abd53	2026-01-15	Warnings	Exact identifier application number: M003
Gold Bond Hydrating Hand Sanitizer	ETHYL ALCOHOL	Chattem, Inc.	96fe0191-0d34-4bf3-8f93-0e64764c353a	2026-01-14	Warnings	Exact identifier application number: M003
Alcohol Prep Awabs	ISOPROPYL ALCOHOL	Enlightening Pallet Industry Co., Limited	26c7db1e-86a9-8765-e063-6294a90a634f	2026-01-14	Warnings	Exact identifier application number: M003
Caring Hands	HAND MOISTURIZING SANITIZER	Gleeco Labs LLC	2ced5dc5-47dd-1b71-e063-6394a90a0e3d	2026-01-14	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	DealMed Medical Supplies LLC	04e6edb5-07ef-4ed4-ba68-ed183386b5ab	2026-01-13	Warnings	Exact identifier application number: M003
Dermoplast First Aid	BENZETHONIUM CHLORIDE AND BENZOCAINE	Advantice Health, LLC	ec93011d-7069-4021-8dd2-3d51eb6026e1	2026-01-13	Warnings	Exact identifier application number: M003
WISH ISOPROPYL ALCOHOL	WISH ISOPROPYL ALCOHOL	Click Products LLC	484befce-ecfe-5514-e063-6294a90a169c	2026-01-13	Warnings	Exact identifier application number: M003
WISH RUBBING ALCOHOL 32oz	WISH RUBBING ALCOHOL 32OZ 70%	CLICK PRODUCTS LLC	4836b564-0b8c-2fb4-e063-6394a90a9c4a	2026-01-13	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	DealMed Medical Supplies LLC	6d1ddf10-8873-4781-9165-bb1c4bbccfc9	2026-01-13	Warnings	Exact identifier application number: M003
AVANCE INCONTINENCE CARE	BENZETHONIUM CHLORIDE	SMART CHOICE MEDICAL INC.	e2c51699-d4da-5b88-e053-2995a90afd7f	2026-01-12	Warnings	Exact identifier application number: M003
AVANCE INCONTINENCE CARE	BENZETHONIUM CHLORIDE	SMART CHOICE MEDICAL INC.	e297b705-8070-f7c3-e053-2a95a90a8c5b	2026-01-12	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Hydrox Laboratories	6e5709b4-cc56-4768-b704-1d9b0e3efec7	2026-01-12	Warnings	Exact identifier application number: M003
Isopropyl Alcohol 50%	ISOPROPYL ALCOHOL 50%	Hydrox Laboratories	930bb3a3-5ca3-414c-b4fb-c71ee17fc746	2026-01-12	Warnings	Exact identifier application number: M003
Povidone Iodine	POVIDONE-IODINE	Sion Biotext Medical Ltd	04438f9e-302c-431b-b3ad-d2c50ca01ad8	2026-01-12	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Hydrox Laboratories	f2f07464-6bd5-434c-8dea-0ba659c0e549	2026-01-12	Warnings	Exact identifier application number: M003
Isopropyl Alcohol with Wintergreen 70%	ISOPROPYL ALCOHOL WITH WINTERGREEN 70%	Hydrox Laboratories	5845f723-8866-4738-bec6-621041899f57	2026-01-12	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Hydrox Laboratories	2042cf29-52c5-4f1e-aae6-78e025994d18	2026-01-12	Warnings	Exact identifier application number: M003
Isopropyl Alcohol with Wintergreen 50%	ISOPROPYL ALCOHOL WITH WINTERGREEN 50%	Hydrox Laboratories	3a15a900-2b48-487f-b252-a1a1e0d0abfc	2026-01-12	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