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 61 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Meijer Hand Sanitizer Lakeshore Fresh ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 41533b69-05e7-d5f7-e063-6294a90a2d2b 2025-10-16 Warnings Exact identifier application number: M003 Meijer Hand Sanitizer Pine Forest ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 4153ac2a-e51c-f167-e063-6394a90a80d8 2025-10-16 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Watermelon ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 412e961a-b7d4-b1c2-e063-6294a90a6b85 2025-10-15 Warnings Exact identifier application number: M003 equate First Aid Antiseptic POVIDONE-IODINE Walmart Inc. 43bbedec-be30-482a-8552-949b13d4bea1 2025-10-14 Warnings Exact identifier application number: M003 Tridergel BENZALKONIUM CHLORIDE Trifluent Pharma LLC f12d9e8c-1d69-49d9-a9e9-a392c681aa6c 2025-10-13 Warnings Exact identifier application number: M003 Be Smart Get Prepared Sting Relief Wipe BENZOCAINE, ALCOHOL Total Resources International, Inc 5415073f-aa1d-4ed3-aa30-7470cd2efed1 2025-10-10 Warnings Exact identifier application number: M003 Lemyn Organics Medical-Grade Hand Sanitizer ALCOHOL Lemyn LLC b106289d-346a-74df-e053-2995a90aa426 2025-10-10 Warnings Exact identifier application number: M003 Dr Lift Antibacterial Body Wash BENZALKONIUM CHLORIDE Spa de Soleil ab9dde33-1bd2-062f-e053-2a95a90a4d18 2025-10-10 Warnings Exact identifier application number: M003 Dr Lift Antibacterial BENZALKONIUM CHLORIDE Spa de Soleil af89675e-e66f-0922-e053-2995a90ab9d2 2025-10-10 Warnings Exact identifier application number: M003 ANTISEPTIC WIPE 01 BENZALKONIUM CHLORIDE Total Resources International Inc. cf4a6a97-529e-7f11-e053-2a95a90a75a9 2025-10-10 Warnings Exact identifier application number: M003 Be Smart Get Prepared Sting Relief Wipe ALCOHOL, LIDOCAINE HYDROCHLORIDE Total Resources International, Inc fff6f057-739e-40f1-8427-e1364c65af05 2025-10-09 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL Zhejiang Hudson Import& Export Co., Ltd 40b6c96c-e36f-6588-e063-6394a90adb46 2025-10-09 Warnings Exact identifier application number: M003 Curad ISOPROPYL ALCOHOL Medline Industries, LP c42de981-4e3f-1ac9-e053-2995a90aea98 2025-10-09 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL Avaria Health & Beauty Corp a3d87ef6-752b-b54b-e053-2a95a90af963 2025-10-08 Warnings Exact identifier application number: M003 Iodo Blanco (Iodine Tincture Decolorized) First Aid Antiseptic IODINE 2% Germa Products, LLC bf54254f-2ef3-102e-e053-2995a90ac083 2025-10-08 Warnings Exact identifier application number: M003 MediChoice BZK Antiseptic BENZALKONIUM CHLORIDE O&M HALYARD, INC. 82a7710d-a9fa-4f68-8322-046a765ae929 2025-10-08 Warnings Exact identifier application number: M003 MediChoice Cleansing BENZALKONIUM CHLORIDE O&M HALYARD, INC. 79d41cf0-301f-44d4-a76c-f4850c7ddce9 2025-10-08 Warnings Exact identifier application number: M003 MediChoice Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL O&M HALYARD, INC. 8b84c8ed-040e-4c07-94cb-d5bdda744648 2025-10-08 Warnings Exact identifier application number: M003 MediChoice of Hydrogen Peroxide 3 10 Volume HYDROGEN PEROXIDE O&M HALYARD, INC. 34e77ef4-297d-4362-8f6e-abf80158b7f0 2025-10-08 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE O&M HALYARD, INC. 0ad5990a-a18d-4753-826b-6da313926698 2025-10-08 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