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.
| 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 |
|---|---|
| BENZETHONIUM CHLORIDE | .0012 kg/kg |
| ALLANTOIN | .005 kg/kg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| PH41D05744 | Internal UNII lookup |
| 344S277G0Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5dd97e65-bfb3-468e-a2b1-e56d30da99df | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52261-0601-1 | 2025-03-28 | C162847 | 48780-1 | 2cef2736-83e1-d83d-e063-dadaa90ab31f | BerbereX Wound Gel - Antimicrobial Skin & Wound Hydrogel |
| 52261-0601-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-83e1-d83d-e063-dadaa90ab31f | BerbereX Wound Gel - Antimicrobial Skin & Wound Hydrogel |
DailyMed Package Descriptions#
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ECOLAB Antiseptic | BENZALKONIUM CHLORIDE | Ecolab Food Safety Specialties, Inc. | 933860e7-5a1f-453a-e053-2995a90a4902 | 2025-09-09 | Warnings | M003 |
| ECOLAB Burn Cream | BENZAALKONIUM CHLORIDE, LIDOCAINE HCL | ECOLAB Food Safety Specialties, Inc. | 4b2a7da9-c0e9-61c5-e054-00144ff8d46c | 2025-09-09 | Warnings | M003 |
| ECOLAB Antiseptic | BENZALKONIUM CHLORIDE 0.13% | ECOLAB Food Safety and Specialties, Inc. | 4c982e7b-2489-151f-e054-00144ff88e88 | 2025-09-09 | Warnings | M003 |
| Thompson Antiseptic | BENZALKONIUM CHLORIDE | Thompson | f537c81d-1fdc-3e0f-e053-2a95a90a6c2b | 2025-09-09 | Warnings | M003 |
| Medline | BENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDE | Medline Industries, LP | b0b5ff82-db36-7708-e053-2a95a90ad9bb | 2025-09-09 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Champagne Apple | ETHYL ALCOHOL 70% | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 3e6ad099-c770-064f-e063-6294a90a222d | 2025-09-09 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Vanilla Cascade | ETHYL ALCOHOL 70% | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 3e6aef24-f162-5549-e063-6294a90a30b8 | 2025-09-09 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Caramel Cinnamon | ETHYL ALCOHOL 70% | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 3e6aef38-215c-defa-e063-6394a90a46a6 | 2025-09-09 | Warnings | M003 |
| Smart Care Kids Hand Sanitizer Crayola | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 3e44c28e-c6ed-52b4-e063-6394a90a9dd0 | 2025-09-08 | Warnings | M003 |
| Smart Care Kids Hand Sanitizer My Little Pony | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 3e45fe7d-b30c-9273-e063-6294a90ae8e1 | 2025-09-08 | Warnings | M003 |
| Smart Care Kids Hand Sanitizer Peppa pig | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 3e466475-351f-614e-e063-6394a90ab25a | 2025-09-08 | Warnings | M003 |
| Smart Care Kids Hand Sanitizer Squishmallows | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 3e46fe11-247f-36ad-e063-6294a90a1dd4 | 2025-09-08 | Warnings | M003 |
| Green Guard Super Stat Blood Clotting First Aid | BENZETHONIUM CHLORIDE AND LIDOCAINE | Unifirst First Aid Corporation | 47355df2-de67-4cf9-b367-645228e494ce | 2025-09-08 | Warnings | M003 |
| Blood Clotting First Aid | BENZETHONIUM CHLORIDE AND LIDOCAINE | Unifirst First Aid Corporation | 2e544963-aa49-49cd-837e-9d89d86e257f | 2025-09-08 | Warnings | M003 |
| Medi-first Protective Coating Bandage | BENZETHONIUM CHLORIDE AND BENZOCAINE | Unifirst First Aid Corporation | 05b0aef9-1553-4e95-8798-f41e5999bb46 | 2025-09-08 | Warnings | M003 |
| Antiseptic | BENZALKONIUM CHLORIDE | Unifirst First Aid Corporation | 3f7fb451-e701-4aa8-814e-ceeb5c2198d9 | 2025-09-08 | Warnings | M003 |
| Medi-First Plus Alcohol Wipes | 70% ISOPROPYL ALCOHOL | Unifirst First Aid Corporation | 3f507990-282a-4b26-e054-00144ff8d46c | 2025-09-08 | Warnings | M003 |
| Green Guard Sterile Alcohol Wipes | ISOPROPYL ALCOHOL 70% | Unifirst First Aid Corporation | 570baa70-e519-328b-e054-00144ff8d46c | 2025-09-08 | Warnings | M003 |
| Medi-First Plus Antiseptic Wipes | BENZALKONIUM CHLORIDE | Unifirst First Aid Corporation | 5743634b-f329-5fec-e053-2991aa0a751d | 2025-09-08 | Warnings | M003 |
| Green Guard Antiseptic Wipes | BENZALKONIUM CHLORIDE | UniFirst First Aid Corporation | 1bdd57c3-cdaf-a085-e063-6394a90a1e3d | 2025-09-08 | Warnings | M003 |
Packages#
| 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 |