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 |
|---|---|---|---|---|---|---|
| First Aid Only Sting Relief Pad | BENZOCAINE, ISOPROPYL ALCOHOL | Acme United Corporation | d71047f6-1353-c758-e053-2995a90a962c | 2024-11-26 | Warnings | M003 |
| First Aid Only Alcohol Antiseptic Pad | ISOPROPYL ALCOHOL | Acme United Coporation | a01fec1b-1339-40b9-e053-2995a90aeda5 | 2024-11-23 | Warnings | M003 |
| Med-Nap Sterile Alcohol Prep Pads | ISOPROPYL ALCOHOL | Acme United Corporation | c6eff57b-d537-69c8-e053-2a95a90adc3a | 2024-11-23 | Warnings | M003 |
| First Aid Only Alcohol Antiseptic | ISOPROPYL ALCOHOL | Acme United Corporation | a810e723-ad0c-8c71-e053-2995a90a0acc | 2024-11-23 | Warnings | M003 |
| Universal 50% Rubbing Alcohol | ISOPROPYL ALCOHOL | Universal Distribution Center LLC | 0dcc9bd2-aea5-4c27-9956-47d56221726b | 2024-11-22 | Warnings | M003 |
| Universal 70% Rubbing Alcohol with Wintergreen and Glycerin | ISOPROPYL ALCOHOL | Universal Distribution Center LLC | 9a9d42ad-79d5-4acc-b5d9-cb7468961d47 | 2024-11-22 | Warnings | M003 |
| Universal 50% Rubbing Alcohol with Wintergreen and Glycerin | ISOPROPYL ALCOHOL | Universal Distribution Center LLC | 044a6287-f568-4cfa-a813-7fc0e6ffc352 | 2024-11-22 | Warnings | M003 |
| NEXXGEN 70% RUBBING ALCOHOL | ISOPROPYL ALCOHOL | A & A Nexxgen LLC | ce73ac48-c5af-4a35-950c-62ff0232aa30 | 2024-11-22 | Warnings | M003 |
| Universal 70% Rubbing Alcohol | ISOPROPYL ALCOHOL | Universal Distribution Center LLC | d8b9b0e7-2cb8-4fc5-af55-790e64d6cfe8 | 2024-11-22 | Warnings | M003 |
| Alcohol sterile | ISOPROPYL ALCOHOL | Cardinal Health, Inc | bb7c530f-5d80-4158-b715-09c1c837299d | 2024-11-21 | Warnings | M003 |
| Alcohol sterile | ISOPROPYL ALCOHOL | Cardinal Health 200 LLC | 10135db9-f614-4511-96ac-faa6a02a1b61 | 2024-11-21 | Warnings | M003 |
| BZK Antiseptic Swabsticks 4 Triple | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd | d9f35c14-2f5a-4e1a-bc2b-a7e163134213 | 2024-11-21 | Warnings | M003 |
| Povidone-lodine Swabsticks Triple | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 74e70ea9-640b-4295-a40f-56f65fca1300 | 2024-11-21 | Warnings | M003 |
| MK Alcohol Prep Pads Medium | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd | 37f10b1f-b73c-4d71-91c2-1252f3d9d4ce | 2024-11-21 | Warnings | M003 |
| BZK Antiseptic Towelette | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd | 1936d749-bf38-a433-e063-6294a90aba8c | 2024-11-21 | Warnings | M003 |
| Maokang 10 Povidone Iodine | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 7c17ce40-0358-44ff-aa60-53711666914b | 2024-11-21 | Warnings | M003 |
| MK Alcohol Prep Pads Medium | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd | 11390854-9e72-40a2-9c89-3c29a585dced | 2024-11-21 | Warnings | M003 |
| Instant Hand Sanitizeing Wipe | ISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTS | Shandong Yayun Sanitary Products Co., Ltd. | aa0dc01a-2c6b-7402-e053-2a95a90af6a2 | 2024-11-21 | Warnings | M003 |
| Dynarex Povidone Iodine Prep Solution | POVIDONE IODINE PREP SOLUTION | Dynarex Corporation | 6bb4d55b-2be7-3549-e053-2a91aa0a2bb0 | 2024-11-20 | Warnings | M003 |
| Dynarex Povidone Iodine Surgical Scrub | POVIDONE IODINE SURGICAL SCRUB SOLUTION | Dynarex Corporation | 6f053e55-cbf6-9072-e053-2991aa0a2edd | 2024-11-20 | 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 |