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 82 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Max Strength Burn Gel	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Walgreens Co.	25a1e89b-bafd-4770-e063-6294a90a14d2	2025-04-07	Warnings	Exact identifier application number: M003
Eye Wash	WATER	CMC Group Inc.	6158a1f5-a6bc-4a3e-9d1d-0a310d9dc561	2025-04-02	Warnings	Exact identifier application number: M003
Standard ANSI First Aid	WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE	CMC Group, Inc.	e1ef74bf-8895-4200-a411-f726dcdaa945	2025-04-02	Warnings	Exact identifier application number: M003
Clear Defense	ETHYL ALCOHOL	Melaleuca, Inc.	a2178a68-780e-e69b-e053-2a95a90ab7d6	2025-04-02	Warnings	Exact identifier application number: M003
Large ANSI First Aid Kit	WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE	CMC Group, Inc.	fa8578c2-a0bc-4e2e-a4f9-d48debfff378	2025-04-02	Warnings	Exact identifier application number: M003
ETHYL ALCOHOL	ALCOHOL	ASP Global LLC	67a4b949-ce8a-4841-a965-fcc94165135c	2025-04-02	Warnings	Exact identifier application number: M003
Sanitizing Hand Mist	ETHYL ALCOHOL	ALO New York LLC	31baefe1-2521-9ef3-e063-6294a90a450e	2025-04-01	Warnings	Exact identifier application number: M003
Deconimo	HAND SANITIZING WIPES	IMAGINE AMAZON LLC	311c670d-8f87-b746-e063-6294a90afd5e	2025-04-01	Warnings	Exact identifier application number: M003
Meijer Antibacterial Foaming Hand Wash	0.13% BENZALKONIUM CHLORIDE SOLUTION	Meijer, Inc.	1eb6b603-ef96-dfda-e063-6294a90ae468	2025-03-31	Warnings	Exact identifier application number: M003
Beautifier Life Hand Sanitizer Mist Ocean	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	31628598-f7b8-111b-e063-6394a90a3de2	2025-03-28	Warnings	Exact identifier application number: M003
Beautifier Life Hand Sanitizer Mist Watermelon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	31633195-d964-278b-e063-6294a90ad42d	2025-03-28	Warnings	Exact identifier application number: M003
Beautifier Life Hand Sanitizer Mist Cucumber	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	31642cc2-c3f6-891d-e063-6294a90a2858	2025-03-28	Warnings	Exact identifier application number: M003
Meijer	BENZALKONIUM CHLORIDE	Meijer	1e69a1b6-1b2b-8db7-e063-6294a90a78e9	2025-03-28	Warnings	Exact identifier application number: M003
Berberex Wound Gel	BENZETHONIUM CHLORIDE, ALLANTOIN	Cosco International, Inc.	5dd97e65-bfb3-468e-a2b1-e56d30da99df	2025-03-28	Warnings	Exact identifier application number: M003 ndc (product): 52261-0601
ANTIBACTERIAL BANDAGES	BENZALKONIUM CHLORIDE	Guangdong Comfort Medical Products Co., Ltd.	da241df2-6153-05e4-e053-2a95a90a0984	2025-03-26	Warnings	Exact identifier application number: M003
Caring Mill Hand Advanced Sanitizer	ETHYL ALCOHOL 70%	Veridian Healthcare	312e0fde-8b5b-1296-e063-6294a90a4f26	2025-03-25	Warnings	Exact identifier application number: M003
HAND SANITIZING WIPES	HAND SANITIZING WIPES	IMAGINE AMAZON LLC	30a373d6-59cd-fc74-e063-6394a90a9a9a	2025-03-24	Warnings	Exact identifier application number: M003
Klean-Them Hand Sanitizing Towels	BENZALKONIUM CHLORIDE	Rite-Kem, Inc.	30dedeee-aadd-6436-e063-6394a90a0cde	2025-03-21	Warnings	Exact identifier application number: M003
Saniiswab	ISOPROPYL ALCOHOL	POLLEY MED LLC	303b1ad5-a104-3479-e063-6294a90abcde	2025-03-20	Warnings	Exact identifier application number: M003
XTRA Squeeze Antibacterial Hand Juicy Orange	BENZALKONIUM CHLORIDE	MY IMPORTS USA LLC	304ab556-36d8-5fba-e063-6394a90a234a	2025-03-19	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