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 |
|---|---|---|---|---|---|---|
| RUBBING ALCOHOL | ALCOHOL | INTERNATIONAL GENERAL TRADING CORP | bd5ee961-1d64-0d9d-e053-2a95a90a6010 | 2024-12-18 | Warnings | M003 |
| 70% Isopropyl Rubbing Alcohol | ISOPROPYL ALCOHOL | SZY Holdings, LLC dba EverReady First Aid | 1e39b0f4-66d1-47ac-aed6-d6ac019888ce | 2024-12-18 | Warnings | M003 |
| RUBBING ALCOHOL | ALCOHOL | INTERNATIONAL GENERAL TRADING CORP | bd5eb0df-cd2d-691c-e053-2995a90a2511 | 2024-12-18 | Warnings | M003 |
| Isopropyl Rubbing Alcohol 70% | ISOPROPYL ALCOHOL | First Aid Research Corp. | 7d1c0382-31b3-48d0-a514-c5cc45a2299e | 2024-12-18 | Warnings | M003 |
| First Aid Only First Aid-Burn | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | Acme United Corporation | f31a44ff-e4ac-de1e-e053-2a95a90ab036 | 2024-12-18 | Warnings | M003 |
| Hand Sanitizer (Lavender Rosemary) | HAND SANITIZER SPRAY | Tubby Todd | 2992a52a-21a9-18be-e063-6294a90a834d | 2024-12-18 | Warnings | M003 |
| CVS Decolorized Iodine | ALCOHOL | CVS Pharmacy | d9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd | 2024-12-18 | Warnings | M003 |
| De La Cruz Decolorized Iodine | ETHYL ALCOHOL | DLC Laboratories, Inc. | 5d8f6aaa-0b87-1166-e053-2991aa0a297f | 2024-12-18 | Warnings | M003 |
| Humco Povidone Iodine | POVIDONE IODINE 10% | Humco Holding Group, Inc. | 1e078022-f32c-48bd-8add-f83aebcc5812 | 2024-12-18 | Warnings | M003 |
| Univ of Vermont Medical Center Amenity | BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE | ASP Global, LLc | 7841cfa9-e94e-4c3d-b5fb-676924017845 | 2024-12-17 | Warnings | M003 |
| Northside Hospital Mothers Vaginal | ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE | ASP Global, LLc | 7f1a85fd-086b-4fc7-abac-863dd3ea505a | 2024-12-17 | Warnings | M003 |
| Mary Kay Satin Hands Shea Hand Sanitizer | ALCOHOL | Mary Kay Inc. | b6c2b979-2940-1569-e053-2995a90a532c | 2024-12-17 | Warnings | M003 |
| Foster and Thrive Decolorized Iodine | ALCOHOL LIQUID | Strategic Sourcing Services, LLC | 2981529a-2bd0-3e9e-e063-6294a90a7236 | 2024-12-17 | Warnings | M003 |
| Foster and Thrive 2% Mild Iodine Tincture | IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID | Strategic Sourcing Services, LLC | 2981cb97-17de-ebda-e063-6394a90ad281 | 2024-12-17 | Warnings | M003 |
| Northside Hospital H.E.A.R.T. Strings Tote | ALCOHOL AND SODIUM MONOFLUOROPHOSPATE | ASP Global, LLc | f8369a27-1995-4fdd-a282-35c344c11d83 | 2024-12-17 | Warnings | M003 |
| Northside Hospital Amenity Kit | ALCOHOL AND SODIUM MONOFLUOROPHOSPATE | ASP Global, LLc | 877ce875-c5b0-4d9b-8f00-682914e3bc0e | 2024-12-17 | Warnings | M003 |
| Wellstar Amenity | BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE | ASP Global, LLc | ced9dd96-7922-43d7-906f-32afaad733ec | 2024-12-17 | Warnings | M003 |
| Northside Hospital C-Section Mothers | ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE | ASP Global, LLc | 9df6d0e9-631c-4619-9d96-d2c5a32a590e | 2024-12-17 | Warnings | M003 |
| Memorial Sloan Kettering Cancer Center Amenity Kit | SODIUM MONOFLUOROPHOSPHATE | ASP Global, LLc | cab0bef1-f486-4eac-a61b-6030467d8650 | 2024-12-17 | Warnings | M003 |
| Sarasota Memorial Amenity | ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE | ASP Global, LLc | f5dda019-fcfd-4e99-89cc-e79e76b402e7 | 2024-12-17 | 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 |