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 |
|---|---|---|---|---|---|---|
| Smart Care Hand Sanitizer Citrus Sunset | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 49f67a60-a6d8-0aa4-e063-6394a90a9859 | 2026-02-03 | Warnings | M003 |
| WIPES4HEALTH | BENZALKONIUM CHLORIDE | Bubble Marketing LLC | 5d6dd15b-d087-4f25-bd2b-035ecacd5f97 | 2026-02-03 | Warnings | M003 |
| Isopropyl alcohol | ISOPROPYL ALCOHOL | Concordance Healthcare Solutions, LLC | 1c051d6a-61a8-4a75-aeb6-7c1258bda2b2 | 2026-02-02 | Warnings, Adverse reactions | M003 |
| Dealmed Sterile Alcohol Prep Pads Large | ISOPROPYL ALCOHOL | Dealmed Medical Supplies, LLC. | 75908e89-abd9-4760-bd11-fb71133ae2c0 | 2026-02-02 | Warnings | M003 |
| Dealmed Sterile Alcohol Prep Pads Medium | ISOPROPYL ALCOHOL | Dealmed Medical Supplies, LLC. | 0cdfc6b4-7d66-4333-b38d-c465d4864b5c | 2026-02-02 | Warnings | M003 |
| Medline | POVIDONE-IODINE | Medline Industries, LP | 494d7e97-a3a8-2c7a-e063-6394a90a3ae1 | 2026-02-02 | Warnings | M003 |
| Aplicare | ISOPROPYL ALCOHOL | Aplicare Products, LLC | 4950e07f-36a5-b6f5-e063-6294a90a8f98 | 2026-02-02 | Warnings | M003 |
| RELEEV Cold Sore Treatment | BENZALKONIUM CHLORIDE | Merix Pharmaceutical Corp. | fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf | 2026-02-02 | Warnings | M003 |
| WISH RUBBING ALCOHOL 91% | ISOPROPYL ALCOHOL | LJ Pharma | 07cba887-a568-4b92-91ab-2e7831f24ab5 | 2026-01-30 | Warnings | M003 |
| First Aid Antiseptic | POVIDONE-IODINE | Rite Aid Corporation | 2f8abb6f-460f-47bf-811d-734126aa3f0b | 2026-01-30 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Rite Aid Corporation | c074bbaf-2fd7-485a-9e22-a368d8dd4701 | 2026-01-30 | Warnings, Adverse reactions | M003 |
| Drs. pharmacy triple antibiotic plus lidocaine | BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, LIDOCAINE OINTMENT | OL PHARMA TECH, LLC | 49a73b0f-90d9-3a4b-e063-6294a90acfb0 | 2026-01-30 | Warnings | M003 |
| HAND SANITIZER WIPES | HAND SANITIZER WIPES | Shandong Baihe Sanitary Products Co., Ltd. | 49822c99-1181-ae42-e063-6394a90a8202 | 2026-01-29 | Warnings | M003 |
| WISH RUBBING ALCOHOL 50% | ISOPROPYL ALCOHOL | LJ Pharma | 15b4a45d-3dbf-48e4-8f90-15dca7e650d9 | 2026-01-29 | Warnings | M003 |
| WISH RUBBING ALCOHOL 50% Winter Green | ISOPROPYL ALCOHOL | LJ Pharma | fbb45bde-b733-4524-bfa9-ae819ad39973 | 2026-01-29 | Warnings | M003 |
| Walmart | ISOPROPYL ALCOHOL | Walmart Inc. | 1d75799d-081e-a38b-e063-6294a90adf35 | 2026-01-29 | Warnings | M003 |
| Liquid Bandage | BENZETHONIUM CHLORIDE AND DYCLONINE HYDROCHLORIDE | Wal-Mart Stores, Inc. | f3911d79-3169-71c3-e053-2a95a90ae843 | 2026-01-29 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Amerifoods Trading Co | 38b15693-7e5f-4c85-915e-9937ea018a83 | 2026-01-29 | Warnings, Adverse reactions | M003 |
| IRIS | ISOPROPYL ALCOHOL | Amerifoods Trading Co | 100e0c3d-96eb-44af-8684-df45a8ab3065 | 2026-01-29 | Warnings, Adverse reactions | M003 |
| First Aid Antiseptic | FIRST AID ANTISEPTIC | Amerisource Bergen | 6719db46-a6e3-4f0a-828c-fe89a5187989 | 2026-01-29 | Warnings, Adverse reactions | 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 |