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 28 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AshleyBelle Moisturizing Hand Sanitizer Coconut Lime ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da93596-ec59-1e56-e063-6394a90afceb 2026-03-22 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Island Vanilla ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da951ff-37fe-4ca4-e063-6394a90a4baf 2026-03-22 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pink Sugar ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da9cb12-3aaf-c0f9-e063-6394a90ae4a4 2026-03-22 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Bellini Glow ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da8a7b6-d147-87c3-e063-6394a90a784c 2026-03-22 Warnings Exact identifier application number: M003 ALCOHOL PREP AWABS ISOPROPYL ALCOHOL PATCH Henan Bingqing Yujie wipes Co., LTD 2e67e417-4dba-73a2-e063-6294a90aa4b2 2026-03-20 Warnings Exact identifier application number: M003 First Aid Antiseptic POVIDONE-IODINE Amazon.com Services LLC 3e2b255c-e3b7-468c-9ac1-b63279c5ac7f 2026-03-20 Warnings, Adverse reactions Exact identifier application number: M003 MediChoice OB Cleansing BENZALKONIUM CHLORIDE O&M HALYARD, INC. ed38fb97-b67d-430b-8f6b-4fc78c16aead 2026-03-17 Warnings Exact identifier application number: M003 MedPRIDE ISOPROPYL ALCOHOL Shield Line LLC f2177bd3-259d-4231-88b2-4a98e48e4df6 2026-03-17 Warnings Exact identifier application number: M003 MedPride 91% Rubbing Alcohol ISOPROPYL ALCOHOL Shield Line LLC e6ffe41e-efdc-0e0a-e053-2995a90a9e6a 2026-03-17 Warnings Exact identifier application number: M003 MedPRIDE with Wintergreen Oil ISOPROPYL ALCOHOL Shield Line LLC 57ac1a5c-758a-4422-8795-40391584434a 2026-03-17 Warnings Exact identifier application number: M003 NOVITA ISOPROPYL ALCOHOL 50% ISOPROPYL ALCOHOL Shield Line LLC 3ad79e91-377d-6587-e054-00144ff8d46c 2026-03-17 Warnings Exact identifier application number: M003 NOVITA 50% ISOPROPYL RUBBING ALCOHOL W/ WINTERGREEN ISOPROPYL ALCOHOL Shield Line LLC 3bd9fc61-b135-51f5-e054-00144ff8d46c 2026-03-17 Warnings Exact identifier application number: M003 Walgreens Burn Gel Packettes BURN GEL PACKETTES Walgreens 3fa09045-d4c0-8119-e063-6394a90ab6a0 2026-03-17 Warnings Exact identifier application number: M003 Limited Edition Hand Sanitizer Pink Satin Prosecco ALCOHOL Scent Theory Products LLC 4d278204-9331-aeb8-e063-6394a90a87a4 2026-03-16 Warnings Exact identifier application number: M003 Limited Edition Hand Sanitizer Cherry Chai ALCOHOL Scent Theory Products LLC 4d27a964-6e91-27c0-e063-6294a90ad994 2026-03-16 Warnings Exact identifier application number: M003 HealthWise Advanced Hand Sanitizer with Lavender ETHYL ALCOHOL 70% Veridian Healthcare 4d144fb3-b4b7-135f-e063-6394a90a366e 2026-03-15 Warnings Exact identifier application number: M003 Biopure Alcohol Cotton Swabs ISOPROPYL ALCOHOL, COTTON SWAB QUEST USA CORP 3a60362b-b397-da15-e063-6394a90a45ff 2026-03-15 Warnings Exact identifier application number: M003 BIOPURE20CT ANTI BACTERIAL HAND WIPES(2010C) ANTIBACTERIAL HAND WIPE Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. a9318c76-7c41-1634-e053-2a95a90a6d44 2026-03-13 Warnings Exact identifier application number: M003 Iodine IODINE Nice-Pak Products, LLC 857f13fe-51c9-4e5b-b5e2-a981dedabf71 2026-03-12 Warnings, Adverse reactions Exact identifier application number: M003 Limited Edition Hand Sanitizer Cashmere Skin ALCOHOL Scent Theory Products LLC 4cdc4282-eb49-3120-e063-6294a90a2d61 2026-03-12 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