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 71 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Smart Care Luxury Hand Sanitizer Whispering Woods ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 394e4b3a-5832-9f8d-e063-6294a90ac449 2025-08-15 Warnings Exact identifier application number: M003 Smart Care Luxury Hand Sanitizer Botanic Blush ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 3c62434b-c2a9-bd39-e063-6294a90af8b3 2025-08-15 Warnings Exact identifier application number: M003 Smart Care Luxury Hand Sanitizer Golden Grove ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 3c62805a-7834-8a27-e063-6394a90a67fe 2025-08-15 Warnings Exact identifier application number: M003 Smart Care Luxury Hand Sanitizer Citrus Suede ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 3c62ecc5-4252-a002-e063-6394a90ace3e 2025-08-15 Warnings Exact identifier application number: M003 AmeriDerm Antibacterial Wash PARACHLOROMETAXYLENOL SHIELD LINE LLC 6e652a7d-76bb-bb2d-e053-2a91aa0aac50 2025-08-15 Warnings Exact identifier application number: M003 AMERIWASH PARACHLOROMETAXYLENOL SHIELD LINE LLC 6d5ed0f9-fb48-7855-e053-2991aa0a18a8 2025-08-15 Warnings Exact identifier application number: M003 365 Whole Foods Market Refreshing Hand Sanitizer Bergamot Rain ETHYL ALCOHOL Whole Foods Market, Inc. 3c6b1a51-4097-1aad-e063-6294a90aef6f 2025-08-15 Warnings Exact identifier application number: M003 MedPride Bath Wipes BENZALKONIUM CHLORIDE Shield Line LLC ecf7e545-21ca-bbe0-e053-2995a90a9a55 2025-08-15 Warnings Exact identifier application number: M003 Smart Care Luxury Hand Sanitizer Midnight Musk ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 3c5f46b4-f202-2a44-e063-6294a90ac106 2025-08-14 Warnings Exact identifier application number: M003 Smart Care Luxury Hand Sanitizer Meadow Mirage ALCOHOL LANTERN HEALTH & BEAUTY SDN. BHD. 3c5f8420-9673-6f77-e063-6294a90a81e4 2025-08-14 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Coconut Breeze ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c3af609-d342-449a-e063-6294a90a0a19 2025-08-13 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Fresh Rain ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c3bd802-56de-ebcd-e063-6294a90aca15 2025-08-13 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Wild Rose ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c3c78f6-e6cb-e456-e063-6394a90ac5b8 2025-08-13 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Champagne Toast ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c4bceac-21bc-486e-e063-6394a90a0f37 2025-08-13 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL HAIAN KANGRUI TEXTILE CO., LTD. 3c25e093-0335-fa1d-e063-6394a90ae684 2025-08-12 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL HAIAN KANGRUI TEXTILE CO., LTD. 3c266de8-0551-374c-e063-6394a90ab9f4 2025-08-12 Warnings Exact identifier application number: M003 Alcohol Free Hand Sanitizer BENZALKONIUM CHLORIDE HAIAN KANGRUI TEXTILE CO., LTD. 3c273544-4562-8f37-e063-6394a90ab4d3 2025-08-12 Warnings Exact identifier application number: M003 HealthWise Lidocaine Cleansing BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE Veridian Healthcare 6022803a-097e-41c6-b9ee-48c8ef380d7a 2025-08-12 Warnings Exact identifier application number: M003 Hand Sanitizer Wipes ISOPROPYL ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c37f72b-623c-c8f6-e063-6294a90a971e 2025-08-12 Warnings Exact identifier application number: M003 HAND SANITIZER VANILLA ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3c236c0b-fccd-6992-e063-6294a90a37ce 2025-08-11 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