Home NDC 52261-0601 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.
FDA-Initiated Inactive NDC Indexing# 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 108 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join White Petrolatum WHITE PETROLATUM Nantong Health & Beyond Hygienic Products Inc. 0f0d6ff0-ff30-aaf8-e063-6394a90a2716 2024-01-16 Warnings Exact identifier application number: M003 Thompson Hand Sanitizer ETHYL ALCOHOL Thompson deada606-8a82-9eeb-e053-2a95a90a9e6d 2024-01-16 Warnings Exact identifier application number: M003 MyMedic Arnica Gel ARNICA MONTANA Nantong Health & Beyond Hygienic Products Inc. 0ef8760d-27c0-7ece-e063-6294a90a6873 2024-01-15 Warnings Exact identifier application number: M003 American Safety First Aid Antispetic HYDROGEN PEROXIDE Orazen Inc ea2fbdfe-1932-9fb4-e053-2a95a90a3563 2024-01-15 Warnings Exact identifier application number: M003 First Aid Antispetic BENZALKONIUM CHLORIDE Orazen Inc ea2debcb-892c-339f-e053-2a95a90a4b18 2024-01-15 Warnings Exact identifier application number: M003 Ever Ready First Aid BENZALKONIUM CHLORIDE, LIDOCAINE HCI Ever Ready First Aid e53f3bf5-25c0-2b86-e053-2a95a90a010f 2024-01-15 Warnings Exact identifier application number: M003 FIRST SHIELD First Aid Antiseptic BENZALKONIUM CHLORIDE Ever Ready First Aid e013ef0a-ef3d-7af5-e053-2a95a90a54d3 2024-01-15 Warnings Exact identifier application number: M003 Latalia Hand Sanitizer 80 Alcohol Antiseptic ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD ae55fab3-3177-383e-e053-2995a90a17a0 2024-01-10 Warnings Exact identifier application number: M003 Latalia Sanitizing Wipe ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD ae564635-898e-fbf6-e053-2995a90a8119 2024-01-10 Warnings Exact identifier application number: M003 Latalia Sanitizing Wipes ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD af850b5e-c99f-3d4e-e053-2995a90a7948 2024-01-10 Warnings Exact identifier application number: M003 Latalia Alcohol Antiseptic 80 Sanitizing ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD ba4b8fb3-09db-fa29-e053-2995a90a8617 2024-01-10 Warnings Exact identifier application number: M003 Northside Hospital Amenity Kit--GI Dept ALCOHOL ASP Global, LLc c284eba4-0b92-4981-b3f8-d8d99b58bdfd 2024-01-10 Warnings Exact identifier application number: M003 Meijer 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Meijer, Inc. 33143d87-3e57-4a17-a96c-b699ad034b5b 2024-01-09 Warnings Exact identifier application number: M003 Meijer 70 Isopropyl Alcohol Wipes First Aid Antiseptic ISOPROPYL ALCOHOL Meijer, Inc 2046162f-cb70-416c-ae37-14999883a807 2024-01-09 Warnings Exact identifier application number: M003 Lightning X Antiseptic BENZALKONIUM CHLORIDE Nantong Health & Beyond Hygienic Products Inc. 0e6b10e7-6e84-6bfc-e063-6294a90a8537 2024-01-08 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE 3.0% Trifecta Pharmaceuticals USA, LLC. e4e45f11-7cd4-e693-e053-2a95a90a4c34 2024-01-02 Warnings Exact identifier application number: M003 GLOBAL CARE GOLD ANTIBACTERIAL HAND BENZALKONIUM CHLORIDE NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 27ba0f30-e066-f240-e063-6394a90ae7cb 2024-01-01 Warnings Exact identifier application number: M003 Freskaro Decolorized Iodine ALCOHOL Pharma Nobis, LLC fbd222a2-1151-99b9-e053-6394a90a8bb8 2023-12-28 Warnings Exact identifier application number: M003 Alcohol Prep ISOPROPYL ALCOHOL Topco Associates 65270825-48b1-49e7-a14e-f73df9beb9dd 2023-12-27 Warnings Exact identifier application number: M003 Humco Hydrogen Peroxide HYDROGEN PEROXIDE 3% Pharma Nobis, LLC e42f876d-0477-c4d5-e053-2a95a90ae6d4 2023-12-26 Warnings Exact identifier application number: M003
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