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 9 of 117 · 2,333 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AEROAID BENZALKONIUM CHLORIDE Aero Healthcare US LLC c9d55d86-0a4e-4c44-96e8-8d13fd16c54d 2026-07-24 Warnings Exact identifier application number: M003 CharmTex All in One Antibacterial Shave Gel Body Wash BENZETHONIUM CHLORIDE Yangzhou Jyr daily chemical Co., Ltd 9c9bfc61-9504-4362-8bdb-c15aa66f5a06 2026-07-23 Warnings Exact identifier application number: M003 Meridian Unwrapped Antibacterial Deodorant BENZETHONIUM CHLORIDE Yangzhou Jyr daily chemical Co., Ltd d4d5cb95-5ee5-4006-b368-f3244fc9cd6c 2026-07-23 Warnings Exact identifier application number: M003 Meridian Antibacterial Deodorant BENZETHONIUM CHLORIDE Yangzhou Jyr daily chemical Co., Ltd 8f10a193-7e01-40df-b62a-73fff5b830e3 2026-07-23 Warnings Exact identifier application number: M003 MISTIFY WATERMELON HYDRATING HAND SANITIZER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 574bf021-6352-e3fc-e063-6394a90ad6de 2026-07-23 Warnings Exact identifier application number: M003 FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, Fresh BENZALKONIUM CHLORIDE Quest USA Corp 5719809b-1c74-4bf3-e063-6294a90ab008 2026-07-23 Warnings Exact identifier application number: M003 First Aid Antiseptic POVIDONE-IODINE 5% Walgreen Company 262ea2c8-f571-1c0b-e063-6394a90af20b 2026-07-22 Warnings Exact identifier application number: M003 Verifine Alcohol Swabs ALCOHOL SWABS Promisemed Hangzhou Meditech Co.,LTD. 5738a502-c5ab-21b0-e063-6294a90a20a7 2026-07-22 Warnings Exact identifier application number: M003 KeepGoing Sting Relief Pad BENZOCAINE AND ISOPROPYL ALCOHOL J&A Digital Inc. a630db1b-1674-4659-a60f-56994b0a1564 2026-07-22 Warnings Exact identifier application number: M003 KeepGoing Alcohol Prep Pad ISOPROPYL ALCOHOL J&A Digital Inc. 5d1e776b-4027-4d05-b02f-8a2701d7bc7a 2026-07-22 Warnings Exact identifier application number: M003 KeepGoing Non Sting Cleaning Wipe BENZALKONIUM CHLORIDE J&A Digital Inc. 1a6303ce-8df7-4e8b-93f2-e162fdd2540c 2026-07-22 Warnings Exact identifier application number: M003 Lights Povidone Iodine Swabsticks POVIDONE-IODINE Lights Medical Manufacture Co., Ltd. 664bbf9f-650a-45fd-b9b8-d93f0ba63190 2026-07-22 Warnings Exact identifier application number: M003 DOCTOR INKS TOPICAL ANTISEPTIC BENZALKONIUM CHLORIDE Enviro Specialty Chemicals Inc d503a2db-e326-4a31-bc6a-5034ad74bf0b 2026-07-21 Warnings Exact identifier application number: M003 MY-SHIELD TOPICAL ANTISEPTIC BENZALKONIUM CHLORIDE Enviro Specialty Chemicals Inc c2c1f5d9-cd6e-4314-9dfc-961ed877c293 2026-07-21 Warnings Exact identifier application number: M003 Germ Free Topical Antiseptic BENZALKONIUM CHLORIDE Enviro Specialty Chemicals Inc 5e004412-1797-4cbf-83e3-7001286ad157 2026-07-21 Warnings Exact identifier application number: M003 Midnight Magic Hand Sanitizer ALCOHOL Scent Theory Products LLC 5721d186-ec6d-fa26-e063-6294a90a76d2 2026-07-21 Warnings Exact identifier application number: M003 McKesson PVP Prep Solution POVIDONE-IODINE McKesson Medical-Surgical 33fa233c-b43c-42d8-af37-a58f098a0d51 2026-07-21 Warnings Exact identifier application number: M003 Twisted Caramel Apple Hand Sanitizer ALCOHOL Scent Theory Products LLC 572a82e3-93ec-9af4-e063-6294a90a9c26 2026-07-21 Warnings Exact identifier application number: M003 Molten Marshmallow Hand Sanitizer ALCOHOL Scent Theory Products LLC 572aa67e-52f7-b424-e063-6394a90ac4ae 2026-07-21 Warnings Exact identifier application number: M003 FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITY BENZALKONIUM CHLORIDE Quest USA Corp 57135b3f-884d-1a03-e063-6294a90ae3e9 2026-07-20 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