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 |
|---|---|---|---|---|---|---|
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Topco Associates LLC | be4f41bd-8a75-4fb6-8d28-67f6f853e6bd | 2026-02-11 | Warnings, Adverse reactions | M003 |
| 70% Isopropyl Rubbing Alcohol | ISOPROPYL RUBBING ALCOHOL | Topco Associates LLC | 9fbded5f-8dc1-4134-a711-48d1a581d874 | 2026-02-11 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Topco Associates LLC | ad1ef2ea-bfc3-4a8a-acd2-55e7f52813d4 | 2026-02-11 | Warnings, Adverse reactions | M003 |
| Antibacterial Wet wipes | BENZALKONIUM CHLORIDE | Zhejiang Easyclean Daily Chemical Co., Ltd. | a1cb6ac9-95f5-3ef1-e053-2a95a90abcdf | 2026-02-11 | Warnings | M003 |
| Universal ISOPROPYL Rubbing Alcohol 70% | ISOPROPYL ALCOHOL | Universal Distribution Center LLC | 0c76f14b-9a0c-4573-96f2-cd4080eb99e6 | 2026-02-10 | Warnings | M003 |
| Ethyl Rubbing Alcohol | ETHYL ALCOHOL | Walgreen Co. | a08ef11f-5c4f-4821-a0c0-d6c89def0bea | 2026-02-10 | Warnings, Adverse reactions | M003 |
| 70% | ISOPROPYL ALCOHOL | Walgreen Co. | fb918e7a-1fe0-4cfd-8cf0-9d823eb56dcc | 2026-02-10 | Warnings, Adverse reactions | M003 |
| AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAM | BENZALKONIUM CL 0.13% V/V | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 49e31509-d489-44be-e063-6394a90a97ef | 2026-02-10 | Warnings | M003 |
| AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAM | BENZALKONIUM CL 0.13% V/V | MY IMPORTS USA LLC | 4a849c4f-9b96-6b20-e063-6394a90a3486 | 2026-02-10 | Warnings | M003 |
| Medline | ISOPROPYL ALCOHOL | Hy-Vee, Inc. | 4bbce274-1e62-0c6a-e063-6394a90af92f | 2026-02-10 | Warnings | M003 |
| Everlit Care Products Antiseptic Wipe | ANTISEPTIC WIPE | EVERLIT GLOBAL INC. | 3331e2f1-c3d0-41fc-a792-be5dcdf4e24a | 2026-02-09 | Warnings | M003 |
| EVERLIT CARE PRODUCTS PREP PAD | ISOPROPYL ALCOHOL | EVERLIT GLOBAL INC. | 77a60360-8bb5-43e9-b7e4-f71d2d488c44 | 2026-02-09 | Warnings | M003 |
| Everlit Care Products Sting Relief | ISOPROPYL ALCOHOL | EVERLIT GLOBAL INC. | adfab206-b7de-4f6a-a864-edd946ea743d | 2026-02-09 | Warnings | M003 |
| EVERLIT CARE PRODUCTS IODINE PREP PAD | POVIDONE-IODINE | EVERLIT GLOBAL INC. | 5cbdb73d-333a-4244-a1c0-be430632f0ed | 2026-02-09 | Warnings | M003 |
| Alcohol | ISOPROPYL ALCOHOL | A-S Medication Solutions | 6b8834be-0235-4f7c-8d52-c2f6aa2d3049 | 2026-02-08 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Salado Sales Inc. | 78a46975-568a-4a88-8597-9603b8bbf935 | 2026-02-06 | Warnings, Adverse reactions | M003 |
| 70% Rubbing | ISOPROPYL ALCOHOL | Walgreens Co. | 6ad37d18-5c19-4b5f-8313-edd430f84fb0 | 2026-02-05 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Walgreens Co. | 1473e6e4-dc5f-43d9-a249-111a181e3f76 | 2026-02-05 | Warnings, Adverse reactions | M003 |
| Aquarrelle Antibacterial Wipes 40 | BENZALKONIUM CHLORIDE | Kimberly-Clark De Mexico, S.A.B.deC.V. | 3584680e-71b0-23b6-e063-6294a90a6998 | 2026-02-05 | Warnings | M003 |
| Aquarrelle Antibacterial Wipes 20 | BENZALKONIUM CHLORIDE | Kimberly-Clark De Mexico, S.A.B.deC.V. | 35865d33-a99f-1b37-e063-6394a90a00d2 | 2026-02-05 | 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 |