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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Grocery Outlet, Inc. | 3dffcbdb-f9cd-bfdd-e063-6394a90a35a4 | 2026-02-04 | Warnings, Adverse reactions | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | HARRIS TEETER | a90eba84-fc0f-48d7-b94e-1507f981800d | 2026-02-04 | Warnings | M003 |
| 91% ISOPROPYL ALCOHOL | 91% ISOPROPYL ALCOHOL | Hy-Vee, Inc. | 497471bb-541c-f945-e063-6294a90adbb2 | 2026-02-04 | Warnings, Adverse reactions | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Hy-Vee, Inc. | 48316d8f-595b-7087-e063-6294a90a29ce | 2026-02-04 | Warnings, Adverse reactions | M003 |
| Isopropyl Rubbing Alcohol | ISOPROPYL RUBBING ALCOHOL | Hy-Vee, Inc. | 4831eecf-d111-6f17-e063-6394a90a4ab9 | 2026-02-04 | Warnings, Adverse reactions | M003 |
| RoyceDerm Antibacterial Body Wash | BENZALKONIUM CHLORIDE 0.13% | RoyceDerm LLC | 4a0c66b1-5a6f-b9b9-e063-6294a90a3d77 | 2026-02-04 | Warnings | M003 |
| Smart Care Hand Sanitizer Sweet Pea Garden | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 49e7ce12-78a6-f86c-e063-6394a90a79e6 | 2026-02-03 | Warnings | M003 |
| Smart Care Hand Sanitizer Jasmine Jewel | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 49e891ac-fa83-f687-e063-6294a90a5255 | 2026-02-03 | Warnings | M003 |
| Smart Care Hand Sanitizer Rosebud | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 49e8bca0-e872-2585-e063-6294a90a34b2 | 2026-02-03 | Warnings | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | CVS Pharmacy, Inc. | 5e3efd36-f11e-4e50-8936-fc54e67eebe5 | 2026-02-03 | Warnings, Adverse reactions | M003 |
| 70% | ISOPROPYL ALCOHOL | CVS Pharmacy, Inc. | fbd9086c-39b2-449c-a06d-b85ec7d2dc72 | 2026-02-03 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | CVS Pharmacy, Inc. | c5f7741b-1f11-4a34-8f11-de6975c9578d | 2026-02-03 | Warnings, Adverse reactions | M003 |
| Ethyl Rubbing Alcohol | ETHYL ALCOHOL | CVS Pharmacy, Inc. | b4238c3a-f6bc-4232-932e-bece53995566 | 2026-02-03 | Warnings, Adverse reactions | M003 |
| Latalia Alcohol Antiseptic 80% Sanitizing | ALCOHOL | INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD | 2da50235-5d89-4774-9c92-bb22cee081f1 | 2026-02-03 | Warnings | M003 |
| Latalia alcohol disinfectant wipes | ETHYL ALCOHOL | INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD | 4ef3c800-1754-4d9c-81d6-5309db7b04cf | 2026-02-03 | Warnings | M003 |
| 70% | ISOPROPYL ALCOHOL | Demoulas Super Markets, Inc | 7cbd8ef5-9744-49ad-9640-d4c2b1ae8203 | 2026-02-03 | Warnings, Adverse reactions | M003 |
| Escudo Ultra-Protect Original | BENZALKONIUM CHLORIDE | Indelpa, Inc | 1cd4c38f-8156-bd74-e063-6394a90a9f56 | 2026-02-03 | Warnings | M003 |
| Escudo Ultra-Protect Soft Care | BENZALKONIUM CHLORIDE | Indelpa, Inc. | 1cc4b68b-dceb-3fab-e063-6294a90ab112 | 2026-02-03 | Warnings | M003 |
| Smart Care Hand Sanitizer Morning Dew | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 49f60996-6a03-77e0-e063-6394a90a7a11 | 2026-02-03 | Warnings | M003 |
| Smart Care Hand Sanitizer Wild Cherry Blossom | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 49f64148-5c63-0107-e063-6294a90a0c45 | 2026-02-03 | 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 |