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 88 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand Sanitizer Pink Sugar	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	322e5a64-dda1-c24e-e063-6394a90a8298	2025-02-01	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Jianerkang Medical Co., Ltd	3fce67c9-14e9-4e26-bb7f-9375a7f84a8a	2025-01-31	Warnings	Exact identifier application number: M003
Antiseptic	ALCOHOL	Welly Health PCB	85ce2c23-25d8-4b35-95ff-99f098d92bc9	2025-01-29	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International Corp.	4e13511b-fbb3-2523-e054-00144ff88e88	2025-01-28	Warnings	Exact identifier application number: M003
Hand Sanitizer 1.8 oz Strawberry Scented	ETHYL ALCOHOL	Ningbo Rejoice International	a267a7a2-79b9-1da3-e053-2995a90a3a11	2025-01-28	Warnings	Exact identifier application number: M003
On Guard Sanitizing Gel	ALCOHOL	doTERRA International, LLC	e4b8b4bb-1d47-6826-e053-2a95a90ab168	2025-01-28	Warnings	Exact identifier application number: M003
germstarLuxe	ETHYL ALCOHOL	Soaptronic, LLC	471b466f-e3e5-3601-e054-00144ff88e88	2025-01-28	Warnings	Exact identifier application number: M003
Refill 4	ISOPROPYL ALCOHOL	GFA Production (Xiamen) Co., Ltd.	51348666-53e3-4cc7-99ba-cf3f23ddbcf6	2025-01-27	Warnings	Exact identifier application number: M003
Refill 3	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	GFA Production (Xiamen) Co., Ltd.	0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa	2025-01-27	Warnings	Exact identifier application number: M003
Easy Care Hand Sanitizer	ALCOHOL	GFA Production (Xiamen) Co., Ltd.	c7058806-ad4e-6d5f-e053-2a95a90a35e8	2025-01-27	Warnings	Exact identifier application number: M003
Hand sanitizer 2oz 2pk with aloe vera	ETHYL ALCOHOL 70%	Rejoice International Corp.	04fd3bbe-1729-a748-e063-6394a90a9655	2025-01-27	Warnings	Exact identifier application number: M003
Hand sanitizer 2oz 2pk lemon	ETHYL ALCOHOL 70%	Rejoice International Corp.	04fd9665-a6b3-678a-e063-6294a90a60a5	2025-01-27	Warnings	Exact identifier application number: M003
GERMSTARORIGINAL	ISOPROPYL ALCOHOL	Soaptronic, LLC	da3ac935-7dc7-4100-a702-959eb84077b2	2025-01-24	Warnings	Exact identifier application number: M003
Germstar Premium Hand Sanitizer	ETHYL ALCOHOL	Soaptronic LLC	489652af-7333-628a-e054-00144ff8d46c	2025-01-24	Warnings	Exact identifier application number: M003
Little Buddy in a Little Tubby	HAND SANITIZING TOWELETTES	Continental Research Corp	f4fac964-4a27-335d-e053-2a95a90ac4eb	2025-01-23	Warnings	Exact identifier application number: M003
PHARMACYS PRESCRIPTION 8OZ HAND SANITIZER	ALCOHOL	American Consumer Products Corp	7a048607-f4c3-6724-e053-2a91aa0ab6f2	2025-01-23	Warnings	Exact identifier application number: M003
SANITAXE 27 OZ INSTANT HAND SANITIZER WITH ALOE VERA	ALCOHOL	American Consumer Products Corp	a8f00148-b8fa-6c4f-e053-2995a90ac5e2	2025-01-23	Warnings	Exact identifier application number: M003
Sanitaxe Antibacterial	BENZALKONIUM CHLORIDE	American Consumer Products Corp	a9ca8aaa-ea76-7eb5-e053-2995a90adef9	2025-01-23	Warnings	Exact identifier application number: M003
Sanitaxe Antibacterial	BENZALKONIUM CHLORIDE	American Consumer Products Corp	a8c6ef84-b072-72ee-e053-2995a90aa111	2025-01-23	Warnings	Exact identifier application number: M003
Hand sanitizer 2oz 2pk lavender	ETHYL ALCOHOL 70%	Rejoice International Corp.	052031f9-5206-c1bc-e063-6394a90ab0f2	2025-01-23	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
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