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 56 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HAND SANITIZING LAVENDER ALCOHOL DR. BRONNER'S MAGIC SOAPS 8383605a-0bac-428c-b1cb-2f95ce9bd35e 2025-10-28 Warnings Exact identifier application number: M003 ORGANIC HAND SANITIZER PEPPERMINT ALCOHOL DR. BRONNER'S MAGIC SOAPS cad3a81e-88cb-4f44-a351-b086fd983795 2025-10-28 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Lavender Drift ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 421cfe98-7a20-c37c-e063-6294a90ad4b5 2025-10-27 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Coastal Coconut ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 421ce33e-4639-e881-e063-6394a90a57ef 2025-10-27 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Watermelon Aloe ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 421d994c-bf62-2f40-e063-6294a90a6488 2025-10-27 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Peach Nectar ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 421d7326-d2fd-a845-e063-6394a90a39aa 2025-10-27 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sea Breeze ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 421d7bd9-c892-ec97-e063-6394a90a4b28 2025-10-27 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCake ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 421d7326-d300-a845-e063-6394a90a39aa 2025-10-27 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Vanilla Cloud ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 421d8811-7fb2-aef6-e063-6394a90a1cf8 2025-10-27 Warnings Exact identifier application number: M003 American Red Cross 70% Isopropyl Alcohol ISOPROPYL ALCOHOL(70%CONC.) MY IMPORTS USA LLC 421d7bd9-c893-ec97-e063-6394a90a4b28 2025-10-27 Warnings Exact identifier application number: M003 American Red Cross Antiseptic BENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W) MY IMPORTS USA LLC 421dc192-97ed-0675-e063-6394a90aa156 2025-10-27 Warnings Exact identifier application number: M003 American Red Cross First Aid BENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W) MY IMPORTS USA LLC 421f3150-2027-c6aa-e063-6294a90ab6aa 2025-10-27 Warnings Exact identifier application number: M003 American Red Cross First Aid BENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W) Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 421b402e-233d-cebf-e063-6394a90aa421 2025-10-27 Warnings Exact identifier application number: M003 Germ Attack Hand Sanitizer ALCOHOL Natural Essentials, Inc. 637dcb5f-8870-4613-a227-9fd612617061 2025-10-27 Warnings Exact identifier application number: M003 SOURPATCH KIDS HAND SANITIZER SET WATERMELON ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 42143916-8d2e-dbbe-e063-6294a90a29c4 2025-10-26 Warnings Exact identifier application number: M003 JOLLY RANCHER HAND SANITIZER SET CHERRY ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 42147184-18e6-f932-e063-6294a90a807e 2025-10-26 Warnings Exact identifier application number: M003 JOLLY RANCHER HAND SANITIZER CHERRY ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 4214ba08-8d00-8de9-e063-6394a90a4c90 2025-10-26 Warnings Exact identifier application number: M003 Sour Patch Kids Hand Sanitizer Watermelon ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 4214f0de-6b1d-dae7-e063-6294a90ade42 2025-10-26 Warnings Exact identifier application number: M003 SOURPATCH KIDS HAND SANITIZER STRAWBERRY ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 4215130c-a298-02c7-e063-6394a90a74ff 2025-10-26 Warnings Exact identifier application number: M003 SMARTIES ORANGE HAND SANTIZER SET ORANGE CREAMSICLE ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 421b1732-acdd-a6cc-e063-6394a90a5fb4 2025-10-26 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