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 Rubbing Alcohol | ISOPROPYL ALCOHOL | Discount Drug Mart | 37a6c0fb-e9c4-4a95-9539-ca5766b3a701 | 2026-01-12 | Warnings | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Discount Drug Mart | 7ac6b062-b471-4653-9d6f-de2ca8f8b014 | 2026-01-12 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Discount Drug Mart | 7663654d-3697-40aa-8357-0978be7773a4 | 2026-01-12 | Warnings | M003 |
| Isopropyl Rubbing Alcohol | ISOPROPYL ALCOHOL | Epic Medical Supply Corp. | 88e6418c-ceb3-4bd6-8765-b476d8bf3ff3 | 2026-01-12 | Warnings | M003 |
| WISH HYDROGEN PEROXIDE | WISH HYDROGEN PEROXIDE 3% | CLICK PRODUCTS LLC | 48370aaa-da08-a2ef-e063-6394a90a62b3 | 2026-01-12 | Warnings | M003 |
| SANMO-BL | MOISTURIZING SANITIZER WITH BLUE BEADS | Beacon Promotions, Inc. | 1eb96fb8-d750-9241-e063-6394a90a1cdd | 2026-01-12 | Warnings | M003 |
| Unscented Sanitizer | UNSCENTED SANITIZER | Beacon Promotions, Inc. | 1f96aecf-8ca2-aa27-e063-6394a90abb79 | 2026-01-12 | Warnings | M003 |
| Scented Hand Sanitizer | SCENTED HAND SANITIZER | Beacon Promotions, Inc. | 1f95444c-7587-a07e-e063-6394a90af534 | 2026-01-12 | Warnings | M003 |
| Povidone Iodine Prep Pad | POVIDONE-IODINE | NINGBO TIANBO FIRST AID PRODUCT CO., LTD. | 6d472aef-0d95-4c21-a373-bd16bc7b63ed | 2026-01-12 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | NINGBO TIANBO FIRST AID PRODUCT CO., LTD. | 3cce065a-0254-43ad-a96f-aae6979997be | 2026-01-12 | Warnings | M003 |
| Quality Choice Isopropyl Alcohol Wipes | ISOPROPYL ALCOHOL | Chain Drug Marketing Association, Inc. | b58145c6-0f6c-5a47-e053-2995a90a5d7f | 2026-01-09 | Warnings | M003 |
| Quality Choice Hydrogen Peroxide Wipes | HYDROGEN PEROXIDE | Chain Drug Marketing Association, Inc. | b5815ca2-edaa-bc8c-e053-2a95a90a3df2 | 2026-01-09 | Warnings | M003 |
| ISOPROPYL RUBBING ALCOHOL 50 PERCENT | ISOPROPYL ALCOHOL | JC SALES | 1f3466d2-6a2e-f871-e063-6394a90af085 | 2026-01-09 | Warnings | M003 |
| NOxyDERM | BENZALKONIUM CHLORIDE | NOxy Health Products | 1e2cb45c-7e70-01dd-e063-6294a90aa16b | 2026-01-09 | Warnings | M003 |
| NOxyDERM | BENZALKONIUM CHLORIDE | NOxy Health Products | 063a1e99-dda6-9cb9-e063-6294a90aa1b3 | 2026-01-09 | Warnings | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Epic Medical Supply Corp. | 04ac8597-00fa-458f-a929-ada5042a8c38 | 2026-01-09 | Warnings | M003 |
| Instant Hand Sanitizeing Wipe | ALCOHOL | SHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD. | bd17c0c7-d824-6b03-e053-2995a90afe15 | 2026-01-08 | Warnings | M003 |
| Surgical Scrub Brush/Sponge With Nail Cleaner 3.3% PCMX | CHLOROXYLENOL | Xinxiang Xinda Technology Co.,Ltd | 125b3c3b-0a3a-9fd3-e063-6394a90a135a | 2026-01-08 | Warnings | M003 |
| Surgical Scrub Brush/Sponge With Nail Cleaner | POVIDONE IODINE | Xinxiang Xinda Technology Co.,Ltd | 125a49c3-15c0-fbad-e063-6394a90a5d2e | 2026-01-08 | Warnings | M003 |
| Surgical Scrub Brush/Sponge With Nail Cleaner 4% CHG | CHLORHEXIDINE GLUCONATE | Xinxiang Xinda Technology Co.,Ltd | 125ac9df-03db-83e9-e063-6394a90afeab | 2026-01-08 | 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 |