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 103 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dermal Wound Cleanser BENZETHONIUM CHLORIDE Smith & Nephew Medical Ltd. 18704cd5-1ecf-4e8c-9897-7e45394e68c8 2024-07-15 Warnings Exact identifier application number: M003 Novex Anti-Bacterial Hand Sanitizer Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 7832a0be-a8ce-4b56-a9bb-a375b97df287 2024-07-10 Warnings Exact identifier application number: M003 Callington Anti-Bacterial Hand Sanitizer Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 00ca48ca-893d-4a3f-ad90-119522664e08 2024-07-10 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Grape 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1c9095ad-ce19-3666-e063-6394a90ae22d 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS ETHYL ALCOHOL MY IMPORTS USA LLC 1ccb78ed-36f9-a7d2-e063-6394a90a6477 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER ETHYL ALCOHOL MY IMPORTS USA LLC 1ccb9671-1970-39f9-e063-6294a90ac079 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY ETHYL ALCOHOL MY IMPORTS USA LLC 1ccbc68e-2b6b-768c-e063-6294a90a643b 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL ETHYL ALCOHOL MY IMPORTS USA LLC 1ccbbc55-3f7d-76d1-e063-6294a90a5590 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb701f7-61c8-e5f4-e063-6294a90a0c3c 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb77267-73ad-efd2-e063-6294a90a43f7 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb7d6ca-ef7e-5225-e063-6294a90aa692 2024-07-08 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Sweet pea 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1cc8a756-852f-6cf8-e063-6394a90a57e6 2024-07-08 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Vanilla 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1cc90b2f-450f-1deb-e063-6394a90a6480 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb4316d-c8c6-3fa2-e063-6394a90a23d2 2024-07-07 Warnings Exact identifier application number: M003 Antibacterial Hand Sanitizer ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd f531053d-82e4-7613-e053-2995a90a349f 2024-07-02 Warnings Exact identifier application number: M003 Antibacterial Hand Sanitizer ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd 1ae5c268-1834-4ac2-931e-bb7fd0088cd2 2024-07-02 Warnings Exact identifier application number: M003 Quality Choice ISOPROPYL ALCOHOL Chain Drug Marketing Association Inc 1262c5d7-63ef-f1c1-e063-6294a90a1f0f 2024-07-02 Warnings Exact identifier application number: M003 Genuine First Aid Antiseptic Towelette BENZALKONIUM CHLORIDE GFA Production (Xiamen) Co., Ltd. dfff78d2-e23c-40b2-8a49-8f4140bb0df6 2024-06-25 Warnings Exact identifier application number: M003 Walgreens 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Walgreen Company 03c497cc-c8b1-43b7-86ba-f9f9fc7432bf 2024-06-18 Warnings Exact identifier application number: M003 Antimicrobial BODY CLEANSER McKesson 8ff06cea-3427-5b40-e053-2995a90a0634 2024-06-17 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