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 |
|---|---|---|---|---|---|---|
| AshleyBelle Moisturizing Hand Sanitizer Honeydew Tart | ETHYL ALCOHOL 70% V/V | MY IMPORTS USA LLC | 462b39e9-cf8e-3268-e063-6394a90a69c0 | 2025-12-17 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Pear Blossom | ETHYL ALCOHOL 70% V/V | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 462a1437-154c-0324-e063-6294a90a1266 | 2025-12-17 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Family Dollar Stores, Inc. | 15af30ec-f77d-2f5c-e063-6394a90a0580 | 2025-12-17 | Warnings | M003 |
| Signature Select Isopropyl Alcohol Wipes (40 count) | ISOPROPYL ALCOHOL | Better Living Brands LLC | c9efcad4-f85c-4b10-9984-55549a4ff026 | 2025-12-17 | Warnings | M003 |
| finipil 4 men only | BENZETHONIUM CHLORIDE | Equibal, Inc. | aba2e3e6-6047-416d-8ca3-44f1033671e3 | 2025-12-17 | Warnings | M003 |
| finipil pro/elec | BENZETHONIUM CHLORIDE | Equibal, Inc. | f68aa5db-7a4e-410f-8159-3356d9407d31 | 2025-12-17 | Warnings | M003 |
| Made for Men | BENZETHONIUM CHLORIDE | Equibal, Inc. | d12f748d-7dc5-4cd7-9718-ebb47171d58b | 2025-12-17 | Warnings | M003 |
| QuickMend | BENZETHONIUM CHLORIDE | Equibal, Inc. | 9b0c85a4-9727-4940-a934-0b81a7c938cf | 2025-12-17 | Warnings | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | CVS PHARMACY, INC | 4f628fbd-e213-43ac-9699-d678331f3765 | 2025-12-17 | Warnings | M003 |
| Alcohol Prep | ISOPROPYL ALCOHOL | Dynarex Corporation | 39b20f1b-8d2f-4fa0-8cb9-10cad408e064 | 2025-12-16 | Warnings | M003 |
| finipil Lait 50 | BENZETHONIUM CHLORIDE | Equibal, Inc. | bc630fbc-e428-4d46-8330-fb6f699943fd | 2025-12-16 | Warnings | M003 |
| PS-2205 BZK Antiseptic Towelettes | PS-2205 BZK ANTISEPTIC TOWELETTES | ProStat First Aid LLC | 00772636-8265-a937-e063-6294a90a438a | 2025-12-15 | Warnings | M003 |
| PS-2362 Hand Sanitizer 0.9g packet | PS-2362 HAND SANITIZER 0.9G PACKET | ProStat First Aid LLC | 01c87dff-57e0-017a-e063-6394a90a1600 | 2025-12-15 | Warnings | M003 |
| Antiseptic Wipes | ANTISEPTIC WIPES | ProStat First Aid LLC | 0e120fed-3225-520b-e063-6394a90a9f9e | 2025-12-15 | Warnings | M003 |
| Hand Sanitizer | HAND SANITIZER | Prostat First Aid LLC | 0e241343-db64-3f1c-e063-6394a90ab538 | 2025-12-15 | Warnings | M003 |
| Alcohol Wipes | ALCOHOL WIPES | Front Line Safety | 0e0ca589-834b-495b-e063-6394a90afbd0 | 2025-12-15 | Warnings | M003 |
| Alcohol Wipes | ALCOHOL WIPES | ProStat First Aid LLC | 0e0dd88e-62eb-02c8-e063-6394a90a63d8 | 2025-12-15 | Warnings | M003 |
| Hand Sanitizer | HAND SANITIZER | ProStat First Aid LLC | 0e21f466-d6ed-79c4-e063-6394a90ae988 | 2025-12-15 | Warnings | M003 |
| Alcohol Wipes | ALCOHOL WIPES | ProStat First Aid LLC | 0dfd48bb-3353-6062-e063-6294a90af628 | 2025-12-15 | Warnings | M003 |
| Antiseptic Wipes | ANTISEPTIC WIPES | Front Line Safety | 0e1f3653-d75e-9c9e-e063-6294a90ab639 | 2025-12-15 | 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 |