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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide | 1169 HYDROGEN PEROXIDE SPRAY | Dynarex Corporation | 11854afb-db97-5a43-e063-6394a90aa39c | 2025-11-19 | Warnings | M003 |
| Sani-Spritz | ALCOHOL | ABC Compounding Co., Inc. | ac88c676-c396-4fb8-9e5c-77c726ed69d8 | 2025-11-19 | Warnings | M003 |
| Osceola Supply Inc 6176 | CHLOROXYLENOL | OSCEOLA SUPPLY, INC. | a7dcc6b1-655d-41b3-ab97-913bc4aae01f | 2025-11-19 | Warnings | M003 |
| AMERISILK | BZK | SHIELD LINE LLC | 43f9775c-0448-243e-e063-6294a90a9e22 | 2025-11-19 | Warnings | M003 |
| Antibacterial Foamy Mango High Foaming Antiseptic Hand and Body Wash | CHLOROXYLENOL | Carpet Rentals, Inc. | a95b4d71-119e-4c3b-a280-09bd4533252b | 2025-11-18 | Warnings | M003 |
| Petroleum | WHITE PETROLATUM | QUALITY CHOICE (Chain Drug Marketing Association) | 684ac03a-f9b1-412d-8ce5-819ca132dc34 | 2025-11-17 | Warnings | M003 |
| Alcohol Prep Pad | ISOPROPYL ALCOHOL | Shandong Lianfa Medical Plastic Products CO.,LTD | 435fd382-d2f5-b07f-e063-6294a90a7d8a | 2025-11-14 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Shandong Lianfa Medical Plastic Products CO.,LTD | 43401653-b260-e86d-e063-6294a90abb3f | 2025-11-13 | Warnings | M003 |
| CVS Health Isopropyl Rubbing Alcohol Pads | ISOPROPYL ALCOHOL | CVS Health | c8d4f3b3-166c-2411-e053-2a95a90abb4a | 2025-11-12 | Warnings | M003 |
| Petroleum | WHITE PETROLATUM | QUALITY CHOICE (Chain Drug Marketing Association) | e3100877-6261-4502-8db8-d8ae3af6cd79 | 2025-11-12 | Warnings | M003 |
| Petroleum | WHITE PETROLATUM | QUALITY CHOICE (Chain Drug Marketing Association) | c65ddc74-4666-457d-91bd-138143446bbe | 2025-11-12 | Warnings | M003 |
| Dr Lift Antibacterial Hand Sanitizer | ETHYL ALCOHOL | Spa de Soleil | aba006cd-18db-e42f-e053-2995a90a4607 | 2025-11-12 | Warnings | M003 |
| Recovery Antiseptic Skin Prep | CHLOROXYLENOL | PURKLENZ FORMULATIONS INC. | 94c5ea07-6bdb-42c6-8ce0-0d0711bd7036 | 2025-11-12 | Warnings | M003 |
| PurKlenz | CHLOROXYLENOL | PurKlenz Formulations Inc. | 9f1223a8-a256-46f0-b01d-01b32ca09d48 | 2025-11-12 | Warnings | M003 |
| Meijer Hand Sanitizer Lemon Sorbet | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 434d3071-802b-f598-e063-6394a90a622d | 2025-11-11 | Warnings | M003 |
| Meijer Hand Sanitizer Strawberry Shortcake | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 434d5f7c-f84d-d6f5-e063-6294a90aa6fe | 2025-11-11 | Warnings | M003 |
| Walgreens Hand Sanitizer Pear | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 434ddef3-fe48-138d-e063-6394a90afc91 | 2025-11-11 | Warnings | M003 |
| Isopropyl Rubbing Alcohol 70% | ISOPROPYL ALCOHOL | Jell Pharmaceuticals Pvt. Ltd. | cd9884b7-6df3-5ece-e053-2a95a90ab20e | 2025-11-11 | Warnings | M003 |
| Isopropyl Rubbing Alcohol | ISOPROPYL ALCOHOL | Jell Pharmaceuticals Pvt. Ltd. | cd8643ef-dc83-8bc1-e053-2995a90a007b | 2025-11-11 | Warnings | M003 |
| Betadine Solution Swabsticks | POVIDONE-IODINE | Atlantis Consumer Healthcare, Inc. | 0707b259-52a4-4ae6-b176-d093865906e7 | 2025-11-11 | 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 |