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 52 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Iodine Tincture Mild IODINE AND SODIUM IODIDE AND ALCOHOL Humco Holding Group, Inc. 41c0927e-df40-4f83-8fd4-284ec0c02b60 2025-12-03 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Strawberry ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 451752d3-88bc-9a26-e063-6294a90a288a 2025-12-03 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk - Floral Fresh (Lavender/Wild rose/Rain) ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 45179a84-fa3c-5634-e063-6294a90a0eee 2025-12-03 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk - Classic Men (Ocean/Sandalwood/Cedar and cypress) ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 451711f3-3b22-5d39-e063-6294a90a7894 2025-12-03 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk (Pistachio Brulee / Vanilla Shea /Caramel Honey) ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 4518038c-04ac-0fbe-e063-6294a90a7c32 2025-12-03 Warnings Exact identifier application number: M003 Hand sanitizer HAND SANITIZER SPRAY Guangzhou Baihua Co., Ltd 44f609dd-c864-493f-e063-6294a90a7138 2025-12-02 Warnings Exact identifier application number: M003 AMORA Spray. Hand Sanitizer Watermelon ALCOHOL Longway Technology(Guangzhou) Co., Ltd.- 44fc6694-2933-8700-e063-6294a90a274f 2025-12-02 Warnings Exact identifier application number: M003 AMORA Spray. Hand Sanitizer coconut ALCOHOL Longway Technology(Guangzhou) Co., Ltd. 44fcf3d3-439b-7869-e063-6294a90a19c3 2025-12-02 Warnings Exact identifier application number: M003 MedPride Instant Sanitizer ALCOHOL SHIELD LINE LLC a1c87c06-d4d2-cd0f-e053-2995a90a4eaa 2025-12-02 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Caramel Honey ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 450401c9-2098-9a23-e063-6394a90a2084 2025-12-02 Warnings Exact identifier application number: M003 AMORA Spray. Hand Sanitizer Cherry ALCOHOL Longway Technology(Guangzhou) Co., Ltd. 44e04959-a21e-ba62-e063-6394a90a7192 2025-12-01 Warnings Exact identifier application number: M003 Hand Sanitizer ETHYL ALCOHOL L&R Distributors, Inc. 263457cc-35ff-62fb-e063-6394a90a94da 2025-12-01 Warnings Exact identifier application number: M003 Hand Sanitizer ETHYL ALCOHOL L&R Distributors, Inc. 2507df2c-9069-01c1-e063-6394a90a8596 2025-12-01 Warnings Exact identifier application number: M003 T.N. Dickinsons Wound Cleansing BENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDE Dickinson Brands Inc. c2a8b134-8bb3-4e00-9df4-3229cb372da0 2025-12-01 Warnings Exact identifier application number: M003 safeHands Hand Sanitizer Clean Linen BENZALKONIUM CHLORIDE Safehands Distribution Ne, LLC 86cc04dc-b66d-4d97-b8da-f5e41f2d13d5 2025-11-29 Warnings Exact identifier application number: M003 safeHands Hand Sanitizer Fragrance Free BENZALKONIUM CHLORIDE Safehands Distribution Ne, LLC 0e7af9f7-80a1-4347-89c4-7d9c8b55d65d 2025-11-29 Warnings Exact identifier application number: M003 Klean Freak BENZALKONIUM CHLORIDE KLEAN FREAK, LLC 5376a031-b657-47d4-bf41-c393fdec040b 2025-11-28 Warnings Exact identifier application number: M003 Klean Freak BENZALKONIUM CHLORIDE KLEAN FREAK, LLC 2298e131-3b0c-4104-bf48-5c366d763d45 2025-11-28 Warnings Exact identifier application number: M003 Klean Freak BENZALKONIUM CHLORIDE KLEAN FREAK, LLC be8b96a2-c4a2-41f8-959b-0fe349cff37e 2025-11-28 Warnings Exact identifier application number: M003 Klean Freak BENZALKONIUM CHLORIDE KLEAN FREAK, LLC b35cb3d0-1a2d-4ffc-a32e-faa2ca1312ee 2025-11-28 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