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 6 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrating Hand Sanitizer ROSEWATER SPRITZ	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585cb4fa-6016-1550-e063-6294a90a514d	2026-08-06	Warnings	Exact identifier application number: M003
CharmTex Lightly Scented Antibacterial	BENZETHONIUM CHLORIDE	Yangzhou Jyr daily chemical Co., Ltd	4b642dfa-f044-4410-81e4-142f0497f0f3	2026-08-06	Warnings	Exact identifier application number: M003
antibacterial wipes 01	BENZALKONIUM CHLORIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	585dec39-ccb8-d2ba-e063-6394a90aec0f	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer PASSION MANGO SPLASH	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585df6ce-4625-d5d2-e063-6394a90a7fcb	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer LILY SPRINGS	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e0c24-7f5f-4ba7-e063-6294a90a7597	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer WATERMELON POP	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e3ced-fa45-8576-e063-6294a90af50f	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer ALOE BREEZE	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e647c-2904-2d3f-e063-6394a90a2b79	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer LAVENDER DREAM	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e8222-fad5-4409-e063-6394a90a9c60	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer JUICY APPLE	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585eb222-5495-65ed-e063-6394a90a7cfa	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer PEACH GLOW	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585ed56e-362e-7c50-e063-6394a90a1932	2026-08-06	Warnings	Exact identifier application number: M003
Isopropyl alcohol 70 percent ReadyInCase	ISOPROPYL ALCOHOL	P & L Development, LLC	57c496b3-10ab-4a72-8d8f-42a2256189dd	2026-08-06	Warnings	Exact identifier application number: M003
PROHEAL ALCOHOL PREP PADS	ISOPROPYL ALCOHOL	Click Industries LLC	d272c1f6-e9c9-4099-9d24-f5aae44082ae	2026-08-05	Warnings	Exact identifier application number: M003
Wish Sanitizing Hand Wipes	BENZALKONIUM CHLORIDE	Zhejiang Bright Care Co., Ltd.	c81c0924-bb01-4fa2-b933-8777358e45e7	2026-08-05	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer JAPANESE CHERRY BLOSSOM	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5833c261-021a-2db2-e063-6394a90a22b0	2026-08-04	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Soft Petals	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	583438a6-c06c-87f5-e063-6394a90adec1	2026-08-04	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Hibiscus and Aloe	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5834801e-20e5-bffb-e063-6394a90a0359	2026-08-04	Warnings	Exact identifier application number: M003
Medi-First Antiseptic Wipes	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	d31fe110-6d75-bf15-e053-2a95a90a8694	2026-08-03	Warnings	Exact identifier application number: M003
First Shield	HYDROGEN PEROXIDE	EVER READY FIRST AID	94307d2f-5366-4fdb-b919-4a8658dda058	2026-08-03	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Passion Fruit Splash	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	583159a9-331a-b53b-e063-6294a90a41a3	2026-08-03	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Fresh Squeezed Spearmint	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	581b4b8d-fe65-f297-e063-6394a90a5a43	2026-08-02	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