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 |
|---|---|---|---|---|---|---|
| Meijer | ISOPROPYL ALCOHOL | Meijer Distribution Inc | ca008d84-cf51-3703-e053-2a95a90a9bf1 | 2026-09-04 | Warnings | M003 |
| Walmart | ISOPROPYL ALCOHOL | Walmart, Inc. | 2eff98ba-5736-b07e-e063-6394a90aeea9 | 2026-09-04 | Warnings | M003 |
| Walgreen Alcohol | ISOPROPYL ALCOHOL | Walgreens Company | deeae1ea-3d81-4260-95be-c4f328e3fdef | 2026-09-04 | Warnings | M003 |
| Dollar General | ISOPROPYL ALCOHOL | Dollar General Corporation | 00b2ef34-42d9-523c-e063-6294a90a753d | 2026-09-03 | Warnings | M003 |
| Signature Select Alcohol Prep Pads | ISOPROPYL ALCOHOL | Better Living Brands LLC | 31ce72e3-03a3-1608-e063-6394a90ad850 | 2026-09-03 | Warnings | M003 |
| SurviveX Sting Relief | STING RELIEF WIPE | Changzhou Maokang Medical Products Co., Ltd. | 5a83b1f1-c8dc-cf07-e063-6394a90a20ca | 2026-09-03 | Warnings | M003 |
| Benzethonium chloride Plus Dyclonine hydrochloride | LIQUID BANDAGE | Kroger Co. | fe604470-917f-4cbd-a1e6-ac1dc7c57ff6 | 2026-09-02 | Warnings | M003 |
| Alcohol | ISOPROPYL ALCOHOL | Rite Aid Corporation | 5104f9ab-0b28-449f-a55a-5438713a24df | 2026-09-02 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | UpLift Brands, LLC | 5a81b635-d188-0b29-e063-6294a90a1e4b | 2026-09-02 | Warnings, Adverse reactions | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | CVS Pharmacy, Inc. | 7f518646-c8fe-499a-b5e4-8e5a5a90e01d | 2026-09-02 | Warnings, Adverse reactions | M003 |
| Alcohol | ISOPROPYL ALCOHOL | The Kroger Company | 6551187f-5cde-4149-931f-b057bd760750 | 2026-09-02 | Warnings | M003 |
| Unscented NasalGuard Antiseptic Topical | BENZALKONIUM CHLORIDE | TRUTEK CORP. | eb036e11-a28c-fdc0-e053-2a95a90a9cdb | 2026-09-02 | Warnings | M003 |
| Harris Teeter | ISOPROPYL ALCOHOL | Harris Teeter, LLC | d2bb20bd-ec83-8d80-e053-2a95a90a2bba | 2026-09-02 | Warnings | M003 |
| School Health | ISOPROPYL ALCOHOL | School Health Corporation | db5d0b22-f2d7-23e5-e053-2a95a90aeb51 | 2026-09-02 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Topco Associates | 2642298f-607e-fdca-e063-6394a90a69d9 | 2026-09-02 | Warnings | M003 |
| HUSTLE BUTTER NUMBING | LIDOCAINE HCL, BENZALKONIUM CHLORIDE | H.B.D. DIST. INC. | 5b4d0390-dac6-4a71-9fdc-5c31543e7c5a | 2026-09-02 | Warnings | M003 |
| NasalGuard Antiseptic Topical Cool Menthol | BENZALKONIUM CHLORIDE | TRUTEK CORP. | e9fd3ef8-78ff-6c9f-e053-2a95a90a21a8 | 2026-09-01 | Warnings | M003 |
| Maximum Strength Betadine Clear | BENZALKONIUM CL AND PRAMOXINE HCL | Atlantis Consumer Healthcare, Inc. | 31b94a76-1536-47c0-ab03-e487c2625c58 | 2026-08-31 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a28101f-ea8e-6071-e063-6294a90aad91 | 2026-08-31 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a3e62ce-52dc-121b-e063-6294a90a898f | 2026-08-31 | 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 |