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 75 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HAND SANITIZER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 38b857ee-760c-e98b-e063-6294a90a7c59 2025-06-29 Warnings Exact identifier application number: M003 HAND SANITIZER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 38b857ee-760e-e98b-e063-6294a90a7c59 2025-06-29 Warnings Exact identifier application number: M003 HAND SANITIZER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 38b87b19-7663-d5c5-e063-6294a90a9e87 2025-06-29 Warnings Exact identifier application number: M003 Smart Care Assorted Hand Sanitizer -Passion Fruit ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38895b60-f5a8-880f-e063-6394a90aa706 2025-06-27 Warnings Exact identifier application number: M003 Smart Care Assorted Hand Sanitizer -Hibiscus ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3889d467-b179-bac4-e063-6394a90a6156 2025-06-27 Warnings Exact identifier application number: M003 Smart Care Assorted Hand Sanitize -Cucumber Melon ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 388a975c-b0b6-b80e-e063-6294a90a1814 2025-06-27 Warnings Exact identifier application number: M003 Smart Care Assorted Hand Sanitizer -Sweet Citrus ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 388abca3-12fb-449a-e063-6394a90aea98 2025-06-27 Warnings Exact identifier application number: M003 First Aid Antiseptic POVIDONE-IODINE Rugby Laboratories b2bcb69e-8ffb-23ee-e053-2995a90aee21 2025-06-27 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Caramel Honey ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3874c203-2c8b-79b3-e063-6294a90aedfb 2025-06-26 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Sweet Citrus ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38863865-9361-fd1a-e063-6394a90a84f4 2025-06-26 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Squishmallows Patty ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38613f78-8480-637d-e063-6394a90a4ef3 2025-06-25 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Barbie ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38626ced-5644-9f82-e063-6294a90ac7a1 2025-06-25 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Pistachio Brule ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38715507-d881-d8b3-e063-6394a90ad348 2025-06-25 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Juicy Berry ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3871ec77-de30-0c89-e063-6394a90a9e7a 2025-06-25 Warnings Exact identifier application number: M003 Meijer Hydrating Power Mist Hand Sanitizer- Gingerbread ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 384c26c8-7f2d-8c3a-e063-6394a90aa908 2025-06-24 Warnings Exact identifier application number: M003 Good Neighbor Pharmacy Alcohol Antiseptic Skin Cleanser ISOPROPYL ALCOHOL Amerisouce Bergen fc28cf11-afb9-4295-bee3-735ab10f6bbc 2025-06-24 Warnings Exact identifier application number: M003 Meret Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd. 385def83-38fe-df7f-e063-6394a90abbf0 2025-06-24 Warnings Exact identifier application number: M003 Antibacterial Hand Wipe ANTIBACTERIAL HAND WIPE Fujian Yifa Healthcare Products Co., Ltd. 38381a41-db33-45c6-e063-6394a90a2317 2025-06-23 Warnings Exact identifier application number: M003 Benzethonium chloride Plus Dyclonine hydrochloride LIQUID BANDAGE Rite Aid Corporation 1069226f-dfd0-4028-a033-30fa4b1e835e 2025-06-21 Warnings Exact identifier application number: M003 Cart Wipes Clean Sanitizing Wipes BENZALKONIUM CHLORIDE Carts and Parts INC. 6a8433e8-7b96-44ce-b8e2-c60575898dab 2025-06-18 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