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 | Family Dollar (FAMILY WELLNESS) | 1a3a789d-8c51-4661-84fe-df80ed70e6f1 | 2025-10-03 | Warnings | M003 |
| Equate Antibacterial Fresh Hand Wipes | BENZALKONIUM CHLORIDE | Walmart, Inc. | d2bc26d8-3e46-e479-e053-2995a90abc0a | 2025-10-01 | Warnings | M003 |
| Equate Antibacterial Wipes Fresh | BENZALKONIUM CHLORIDE | Walmart, Inc. | 21d86d5b-46ee-6ffd-e063-6394a90ab0e5 | 2025-10-01 | Warnings | M003 |
| Equate Antibacterial Wipes Citrus | BENZALKONIUM CHLORIDE | Walmart, Inc. | 2450dc1b-0c89-c92a-e063-6394a90afe22 | 2025-10-01 | Warnings | M003 |
| Equate Antibacterial Citrus Hand Wipes | BENZALKONIUM CHLORIDE | Walmart, Inc. | d2cb4c64-66fc-58e4-e053-2a95a90a7f66 | 2025-10-01 | Warnings | M003 |
| Kroger Antibacterial Hand Wipes | BENZALKONIUM CHLORIDE | The Kroger Co. | 17e29138-8c1f-e3b1-e063-6294a90a5d48 | 2025-10-01 | Warnings | M003 |
| Isopropyl alcohol | ISOPROPYL ALCOHOL | Family Dollar (FAMILY WELLNESS) | 2f1c3e24-ea71-4634-9ec1-670349b43a50 | 2025-10-01 | Warnings | M003 |
| Fresh Feels Hand Sanitizer Mist | FRESH FEELS HAND SANITIZER MIST | ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD | 3ffda86b-6b1d-8f0d-e063-6394a90aafaf | 2025-09-30 | Warnings | M003 |
| BIOPURE 50CT ANTI BACTERIAL HAND WIPES | BENZALKONIUM CHLORIDE | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | ee484505-3bb1-2989-e053-2995a90aea2b | 2025-09-30 | Warnings | M003 |
| Xpect First Aid Cream | BENZALKONIUM CHLORIDE, LIDOCAINE HCL | Cintas Corporation | f7112e5d-c8c4-42ad-8a65-24bfc32d4aea | 2025-09-30 | Warnings | M003 |
| Xpect Antiseptic Wipes | ANTISEPTIC CLEANSER | Cintas Corporation | 8f1fd933-965e-42ec-ab96-47cfe780f963 | 2025-09-29 | Warnings | M003 |
| EVR Alcohol Prep Pads | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd. | 3ffba233-6106-f633-e063-6394a90a96fe | 2025-09-29 | Warnings | M003 |
| ProHeal Alcohol Prep Pad | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd. | 3ffc0619-eb13-77af-e063-6394a90a2fd9 | 2025-09-29 | Warnings | M003 |
| ProHeal BZK Antiseptic Towelettes | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd. | 3ffc3f34-086d-1d18-e063-6294a90a71bb | 2025-09-29 | Warnings | M003 |
| First Aid Direct Alcohol Wipe | ISOPROPYL ALCOHOL | Cintas Corporation | 6a71449e-9a97-4923-8ec1-b1deb45b5746 | 2025-09-29 | Warnings | M003 |
| Northside Hospital Mothers Kit, Grey Backpack | ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE | ASP Global, LLc | 0868060e-d593-4cb2-b3d2-6c59d1ae5efc | 2025-09-29 | Warnings | M003 |
| First Aid Direct Antiseptic Wipe | BENZALKONIUM CHLORIDE | Cintas Corporation | a23f3685-7213-4cc0-97b2-588fb1224792 | 2025-09-29 | Warnings | M003 |
| Xpect Alcohol Wipes | ALCOHOL WIPES | Cintas Corporation | 51185b9a-ed6b-4a49-b524-b3ff0d5c6290 | 2025-09-29 | Warnings | M003 |
| Super-Stop BloodClotter | BLOOD CLOTTER | Cintas Corp | d910ee9b-187d-49a9-ab96-281730db2575 | 2025-09-26 | Warnings | M003 |
| Hand Sanitizer plus Holder | BENZALKONIUM CHLORIDE | Aocai Biotechnology Huizhou Co Ltd | 3fa738ce-0a04-fa11-e063-6294a90aba88 | 2025-09-25 | 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 |