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 |
|---|---|---|---|---|---|---|
| Dynarex Green | ALCOHOL | Dynarex Corporation | 072572be-49dd-4594-bc40-b56db57ada5b | 2024-11-20 | Warnings | M003 |
| Dynarex Green | CHLOROXYLENOL | Dynarex Corporation | 59b098d2-08de-4fdb-a209-ae226abf37d6 | 2024-11-20 | Warnings | M003 |
| Baby Wipes | PROPYLENE GLYCOL | Shandong Yayun Sanitary Products Co., Ltd. | aeb9a12c-955f-5030-e053-2995a90a2dd6 | 2024-11-20 | Warnings | M003 |
| Pet wipes | BENZALKONIUM CHLORIDE | Shandong Yayun Sanitary Products Co., Ltd. | 2764ea79-32d8-b7f6-e063-6394a90a5501 | 2024-11-20 | Warnings | M003 |
| Premium Hand Sanitizer | ETHANOL | MCKESSON MEDICAL-SURGICAL INC. | a9514466-e0c6-4792-984a-9f07d94ee887 | 2024-11-18 | Warnings | M003 |
| MARVEL BZK ANTISEPTIC WIPE | BENZALKONIUM CHLORIDE | Ashtel Studios, Inc. | 93ed0bb4-834d-44ca-9c0a-20086fc09ab8 | 2024-11-18 | Warnings | M003 |
| Isopropyl Rubbing Alcohol | ISOPROPYL ALCOHOL | McKesson Medical-Surgical Inc. | 98b0bcc2-539b-4471-ba98-bbe17bb881bd | 2024-11-15 | Warnings | M003 |
| CVS Health Hydrogen Peroxide Wipes | HYDROGEN PEROXIDE | CVS PHARMACY, INC | 7a930a5e-5b69-428f-9cbb-d03dae180295 | 2024-11-12 | Warnings | M003 |
| First Aid Only Povidone-Iodine Prep Pad | POVIDONE-IODINE | Acme United Corporation | 509b6c8e-6a9f-2656-e054-00144ff8d46c | 2024-11-09 | Warnings | M003 |
| MED NAP Cleansing Towelette | BENZALKONIUM CHLORIDE | Acme United Corporation | d92cd45a-234c-4872-e053-2a95a90a3e1c | 2024-11-09 | Warnings | M003 |
| MED NAP Obstetrical Towelette | BENZALKONIUM CHLORIDE | Acme United Corporation | d83d2fab-6972-9b18-e053-2995a90a5cb5 | 2024-11-09 | Warnings | M003 |
| MED NAP Benzalkonium Chloride Antiseptic | BENZALKONIUM CHLORIDE | Acme United Corporation | d7c404c1-c765-a67c-e053-2995a90a6b8e | 2024-11-09 | Warnings | M003 |
| Barbie BZK ANTISEPTIC WIPE | BENZALKONIUM CHLORIDE | Ashtel Studios, Inc. | d675eb91-80a8-4874-a2b0-c2bf69264911 | 2024-11-08 | Warnings | M003 |
| Barbie ALCOHOL WIPE | ISOPROPYL ALCOHOL | Ashtel Studios, Inc. | a4a6beb0-5781-4d74-9120-7ca64e035c23 | 2024-11-08 | Warnings | M003 |
| MARVEL ALCOHOL WIPE | ISOPROPYL ALCOHOL | Ashtel Studios, Inc. | f6cd4757-d6e0-46bd-827f-3f380c71858f | 2024-11-07 | Warnings | M003 |
| Instant Hand Sanitizer | HAND SANITIZER | Raining Rose, Inc. | 2656d129-df88-4489-e063-6394a90a4b49 | 2024-11-07 | Warnings | M003 |
| HealthWise Advanced Hand Sanitizer | ETHYL ALCOHOL 70% | Veridian Healthcare | 261bd056-c2f9-2a69-e063-6394a90af8df | 2024-11-04 | Warnings | M003 |
| Hand Sanitizer Cucumber Aloe | ORGANIC ETHYL ALCOHOL | Whole Foods Market, Inc. | 0588ae1b-f29a-e1b6-e063-6394a90a0de1 | 2024-11-02 | Warnings | M003 |
| Hand Sanitizer Cucumber Aloe | ETHYL ALCOHOL | Whole Foods Market, Inc. | 074334af-c26e-4126-e063-6394a90ae4c4 | 2024-11-02 | Warnings | M003 |
| Hand Sanitizer Orange Blossom | ORGANIC ETHYL ALCOHOL | Whole Foods Market, Inc. | 07f708d1-11c8-eb50-e063-6294a90a3a81 | 2024-11-02 | 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 |