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 22 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lucys Renewals Skin and Nails First Aid Antiseptic BENZETHONIUM CHLORIDE ACP Laboratories LLC a702297d-8f7e-4019-a987-7bd83becb5ee 2026-05-07 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Sea Breeze ALCOHOL Scent Theory Products LLC 3cfac192-84c8-7897-e063-6294a90ae93d 2026-05-06 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Whipped Coconut ALCOHOL Scent Theory Products LLC 3cfaadb3-1881-2dd9-e063-6394a90abcb4 2026-05-06 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Pink Champagne ALCOHOL Scent Theory Products LLC 3cf7a910-28c8-bbe2-e063-6394a90aff73 2026-05-06 Warnings Exact identifier application number: M003 Minee Wipes Antibacterial Hand Wipe BENZALKONIUM CHLORIDE Ambition Power Brands 5132bc70-bf3b-180c-e063-6394a90afdad 2026-05-06 Warnings Exact identifier application number: M003 Kleenex Reveal Moisturizing Foam Hand Sanitizer ALCOHOL Kimberly-Clark 4a491f90-268e-470d-a74c-473f1efe7c8b 2026-05-06 Warnings Exact identifier application number: M003 Boo Crew Hand Care Essentials Boo Berry, Pumpkin Spice ALCOHOL Scent Theory Products LLC 51143d5c-4cd0-0b2e-e063-6294a90a2831 2026-05-05 Warnings Exact identifier application number: M003 Scott Moisturizing Foam Hand Sanitizer ALCOHOL Kimberly-Clark 25900e62-c8fd-4942-ad38-4b9924308460 2026-05-05 Warnings Exact identifier application number: M003 EVERLIT CARE PRODUCTS ANTISEPTIC MIST HYDROGEN PEROXIDE Nantong Health & Beyond Hygienic Products Inc. cb97ba55-d678-4e43-aa85-37e9f530e911 2026-05-04 Warnings Exact identifier application number: M003 EVERLIT CARE PRODUCTS ANTISEPTIC MIST HYDROGEN PEROXIDE EVERLIT GLOBAL INC. 4873b106-4ea2-412c-a7ab-756a11195984 2026-05-04 Warnings Exact identifier application number: M003 Limited Edition Hand Sanitizer Golden Vanilla, Starlight Frost, Pink Satin Prosecco ALCOHOL Scent Theory Products LLC 50f03829-eda8-3a25-e063-6294a90a6fd2 2026-05-03 Warnings Exact identifier application number: M003 DUBBLE BUBBLE HAND SANITIZER BUBBLE GUM ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 52084e0a-ffe2-83f4-e063-6294a90a305e 2026-05-01 Warnings Exact identifier application number: M003 DIPPIN DOTS HAND SANI BIRTHDAY CAKE ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 520828a5-4e8d-b637-e063-6394a90ab491 2026-05-01 Warnings Exact identifier application number: M003 ICEE HAND SANI BLUE RASBERRY ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 52089622-d9b5-b5cb-e063-6394a90ad426 2026-05-01 Warnings Exact identifier application number: M003 DIPPIN DOTS HAND SANITIZER COTTON CANDY ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 5208adea-27da-81a3-e063-6294a90afc80 2026-05-01 Warnings Exact identifier application number: M003 ICEE HAND SANI CHERRY ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 52089622-d9b6-b5cb-e063-6394a90ad426 2026-05-01 Warnings Exact identifier application number: M003 KOOL AID HAND SANITIZER BUBBLE PINK LEMONADE ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 5208bd2c-277c-648e-e063-6294a90a5b28 2026-05-01 Warnings Exact identifier application number: M003 DIPPIN DOTS HAND SANITIZER RAINBOW ICE ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 52092127-7a8d-5db3-e063-6294a90a07b5 2026-05-01 Warnings Exact identifier application number: M003 Liquid death hand sanitizer ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 520943a4-0e63-a9ab-e063-6394a90ab2a9 2026-05-01 Warnings Exact identifier application number: M003 Redicare Antiseptic Towelettes ANTISEPTIC TOWELETTES Redicare LLC 484c8ff5-cc11-b646-e063-6394a90a5f50 2026-05-01 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