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 40 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 Blueberry Freesia ETHYL ALCOHOL MY IMPORTS USA LLC 48f0a73a-66b5-e7d0-e063-6394a90a2333 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar Blossom ETHYL ALCOHOL MY IMPORTS USA LLC 48f127be-8259-5aaa-e063-6294a90a3f1a 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Rose Lychee ETHYL ALCOHOL MY IMPORTS USA LLC 48f2433f-b924-ade1-e063-6394a90a2c9a 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pineapple Soleil ETHYL ALCOHOL MY IMPORTS USA LLC 48f2527c-a83e-f709-e063-6394a90aa030 2026-01-21 Warnings Exact identifier application number: M003 DOP Hydrogen Peroxide 3% HYDROGEN PEROXIDE Omega & Delta Co. Inc. 73edab95-74ff-4f45-a941-634c83a52188 2026-01-21 Warnings Exact identifier application number: M003 DOP Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Omega & Delta Co., Inc. c779a35b-1118-4560-8d77-6878edb4c267 2026-01-21 Warnings Exact identifier application number: M003 Betadine Solution POVIDONE-IODINE Atlantis Consumer Healthcare, Inc. 1b1e224c-8c00-46ea-9bdd-020a9b45321d 2026-01-21 Warnings Exact identifier application number: M003 CVS Hydrogen Peroxide Wipes HYDROGEN PEROXIDE CVS Pharmacy d2c22ab0-9647-4025-8282-6b492209b04c 2026-01-20 Warnings Exact identifier application number: M003 Hand Sanitizing Wipes ALCOHOL Germs Be Gone LLC 2bd6249b-f215-7aa9-e063-6394a90a6580 2026-01-20 Warnings Exact identifier application number: M003 SPA HAND SANITIZER SUMMER LEMON ETHYL ALCOHOL Rejoice International Corp. 48dd563a-0558-cc76-e063-6294a90ab041 2026-01-20 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Blueberry Freesia ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48de4a31-c620-6c1c-e063-6394a90abb96 2026-01-20 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar Blossom ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48df981a-74da-a629-e063-6294a90a7f40 2026-01-20 Warnings Exact identifier application number: M003 Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker Freeze ALCOHOL Scent Theory Products LLC 48c3d5e9-2d57-5a46-e063-6394a90a0722 2026-01-19 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487b648a-1680-6de5-e063-6394a90ab852 2026-01-16 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487e6851-1ca3-f9db-e063-6394a90a56f1 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America, Inc. c3f0556d-f967-4f19-922c-57a2bf184892 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America 3b5b46d0-308a-4649-8384-246da3a18ba1 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America bf69cc74-ebe9-40c3-a95a-a489492cc693 2026-01-16 Warnings Exact identifier application number: M003 NEXXGEN 50% RUBBING ALCOHOL ISOPROPYL ALCOHOL A & A Nexxgen LLC d48232ab-ab55-488a-9cc1-77c8d0ba992e 2026-01-16 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD 486ee2e0-2222-0574-e063-6294a90a9eff 2026-01-15 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