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 |
|---|---|---|---|---|---|---|
| DermaWound Wound Care | POVIDONE-IODINE | Progressive Doctors, LLC | 2d49daa7-aa02-4219-880b-e1697bde8a7e | 2023-12-15 | Warnings | M003 |
| Ethyl Rubbing Alcohol | ALCOHOL | Humco Holding Group, Inc. | 829f3e16-7a9b-4da7-87d2-f58254bda721 | 2023-12-15 | Warnings | M003 |
| Humco Iodides Tincture | ETHYL ALCOHOL | Humco Holding Group, Inc. | d230e3a2-1cde-44a9-82c3-3dc5474b3a72 | 2023-12-15 | Warnings | M003 |
| Humco Hydrogen Peroxide | HYDROGEN PEROXIDE 3% | Humco Holding Group, Inc. | 2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd | 2023-12-15 | Warnings | M003 |
| HUMCO Isopropyl Rubbing Alcohol 70% | ISOPROPYL ALCOHOL | Humco Holding Group, Inc. | c220b916-6914-435f-84e2-ba828c9916b1 | 2023-12-15 | Warnings | M003 |
| HUMCO Isopropyl Rubbing Alcohol 70% Professional Pack | ISOPROPYL ALCOHOL | Humco Holding Group, Inc. | 8de61fdd-8bb9-4845-9129-97bed0686a68 | 2023-12-15 | Warnings | M003 |
| HUMCO Merthiolate | BENZALKONIUM CHLORIDE | Humco Holding Group, Inc. | 864063a5-c6cc-4657-9cd6-51af4673bf98 | 2023-12-15 | Warnings | M003 |
| Povidone Iodine | POVIDONE-IODINE SPRAY 5% | Humco Holding Group, Inc. | a7bb80c4-bbc0-21ea-e053-2995a90a52c1 | 2023-12-15 | Warnings | M003 |
| Povidone Iodine | POVIDONE IODINE 10% | Humco Holding Group, Inc. | 6064c23b-7c15-208d-e053-2991aa0a00f6 | 2023-12-15 | Warnings | M003 |
| Povidone Iodine | POVIDONE IODINE GARGLE 0.5% | Humco Holding Group, Inc. | a7b9ad55-cfeb-6066-e053-2a95a90af975 | 2023-12-15 | Warnings | M003 |
| Rite Aid Povidone Iodine | POVIDONE IODINE 10% | Rite Aid Corporation | 5df6ff37-a4ea-d666-e053-2991aa0a9786 | 2023-12-15 | Warnings | M003 |
| Rite Aid Decolorized Iodine | ETHYL ALCOHOL | Rite Aid Corporation | 5e0d3664-b02a-ba28-e053-2991aa0a8a4c | 2023-12-15 | Warnings | M003 |
| De La Cruz Tincture of Iodine | IODINE AND SODIUM IODIDE AND ALCOHOL | DLC Laboratories, Inc. | 5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b | 2023-12-15 | Warnings | M003 |
| ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIAL | ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 0c73f4f5-2b1d-84ae-e063-6394a90a5d7b | 2023-12-14 | Warnings | M003 |
| TaeTu Aftercare | BENZALKONIUM CHLORIDE | Taetu LLC | dec15a4d-1a33-a78a-e053-2995a90a69fe | 2023-12-14 | Warnings | M003 |
| GNP Idoinde Tincture 2% Mild | IODINE AND SODIUM IODIDE AND ALCOHOL | Amerisource Bergen | 32ad75b8-abd1-4151-a035-b6c9ae5fc888 | 2023-12-14 | Warnings | M003 |
| Antibacterial Wet Wipes | BENZALKONIUM CHLORIDE | HangZhou YangYi Daily Cosmetics Technology Co., Ltd. | 85d3914d-dbb8-5036-e053-2a91aa0a7cd4 | 2023-12-13 | Warnings | M003 |
| AntiochPharma Rapidgel Hand Sanitizer | ALCOHOL | Weeks & Leo | 0c57a9ea-de66-3ced-e063-6294a90a4b8d | 2023-12-12 | Warnings | M003 |
| antiseptic hand sanitizer 01 | ALCOHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | e9f9b7b6-fed7-10e1-e053-2a95a90a9aa6 | 2023-12-11 | Warnings | M003 |
| AntiochPharma Hand Sanitizer | ALCOHOL | Weeks & Leo | a1a0d368-b004-59b8-e053-2995a90ab4b1 | 2023-12-11 | 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 |