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 15 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 70% ISOPROPYL ALCOHOL ADUSA Distribution, LLC f340dd7e-6412-4621-a818-2592ca78d0f2 2026-06-23 Warnings, Adverse reactions Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL ADUSA Distribution, LLC d95a9736-345b-4b7e-9b24-23edb3cbf7e8 2026-06-23 Warnings, Adverse reactions Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL ADUSA Distribution, LLC 7e066163-6629-43ad-b0b8-09c16fe94a0d 2026-06-23 Warnings, Adverse reactions Exact identifier application number: M003 Antibacterial Hand Wipe ANTIBACTERIAL HAND WIPE Fujian Yifa Healthcare Products Co., Ltd. 3ca0168d-8945-907a-e063-6294a90a9deb 2026-06-23 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70 ISOPROPYL ALCOHOL Delon Laboratories (1990) Ltd. fb481568-0c51-421f-9b73-adb4c84645aa 2026-06-22 Warnings Exact identifier application number: M003 Benzethonium chloride and Dyclonine hydrochloride LIQUID BANDAGE Target Corporation 326daa64-165a-cea6-e063-6294a90afbab 2026-06-22 Warnings Exact identifier application number: M003 Medline ISOPROPYL ALCOHOL Medline Industries, LP 495076e9-3187-6bfa-e063-6394a90a01f5 2026-06-22 Warnings Exact identifier application number: M003 Biopure Antibacterial Hand Wipe ANTIBACTERIAL HAND WIPE Fujian Yifa Healthcare Products Co., Ltd. 54def395-2f22-20a4-e063-6294a90a6196 2026-06-22 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizers 2pk Cherry Blossom and French Vanilla ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 54e431cd-98fb-8346-e063-6294a90ad85e 2026-06-22 Warnings Exact identifier application number: M003 Smart Care Holiday Hand Sanitizer-Gingerbread ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 54cea78b-515c-9562-e063-6394a90af1b4 2026-06-21 Warnings Exact identifier application number: M003 Smart Care Holiday Hand Sanitizer-Mistletoe ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 54cecbb4-5d85-dacf-e063-6294a90af807 2026-06-21 Warnings Exact identifier application number: M003 Smart Care Silicone Case for Hand Sanitizer Barbie ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 54cef14d-dd2b-905f-e063-6294a90a66ba 2026-06-21 Warnings Exact identifier application number: M003 Smart Care Silicone Case for Hand Sanitizer Mermicorno ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 54cedd57-03a9-e5e5-e063-6394a90a486b 2026-06-21 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizers 2pk Fresh Rain and Pumpkin Spice ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 54cf590a-2a74-d8fe-e063-6294a90a6438 2026-06-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pineapple Soleil ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48dfb925-add2-f9ef-e063-6394a90a3bab 2026-06-17 Warnings Exact identifier application number: M003 PVP Scrub Solution POVIDONE IODINE McKesson Medical-Surgical Inc. 49db333e-36e1-1965-e054-00144ff8d46c 2026-06-17 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Holiday-Sugar Cookie ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 547e55a6-7d63-2344-e063-6294a90ab4c0 2026-06-17 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Holiday- Gingerbread ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 547e76d4-e7ea-5cac-e063-6394a90a7294 2026-06-17 Warnings Exact identifier application number: M003 Smart Care Holiday Hand Sanitizer-Sugar Cookie ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 547eaf43-ec33-b61a-e063-6294a90af6d9 2026-06-17 Warnings Exact identifier application number: M003 Smart Care Holiday Hand Sanitizer-Candy Cane ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 547ef4f4-6f0b-23ea-e063-6294a90a7533 2026-06-17 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