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 Luxury Hand Sanitizer Cashmere Char | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 41938c11-391c-0a55-e063-6394a90ad451 | 2025-10-20 | Warnings | M003 |
| Smart Care Luxury Hand Sanitizer Tea and Timber | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 4193d08a-bc54-ef3b-e063-6294a90a0608 | 2025-10-20 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Coastal Coconut | ETHYL ALCOHOL 70% V/V | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 41940273-689d-0f44-e063-6294a90a957f | 2025-10-20 | Warnings | M003 |
| Smart Care Luxury Hand Sanitizer Vanilla Verdant | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 41942841-faa9-114e-e063-6294a90a0e58 | 2025-10-20 | Warnings | M003 |
| Smart Care Luxury Hand Sanitizer Zen and Zest | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 419441a8-a6df-e15d-e063-6294a90a02ae | 2025-10-20 | Warnings | M003 |
| CVS Alcohol Prep | ISOPROPYL ALCOHOL | CVS Pharmacy | 7abc66f2-faf6-421c-9c3c-b69f5a587246 | 2025-10-20 | Warnings | M003 |
| Gentian Violet | GENTIAN VIOLET | World Perfumes Inc | 419cc9a2-bfde-a516-e063-6294a90a065c | 2025-10-20 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Lavender Drift | ETHYL ALCOHOL 70% V/V | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 41a2d051-4920-76ee-e063-6294a90a5d3c | 2025-10-20 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Peach Nectar | ETHYL ALCOHOL 70% V/V | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 41a36bb3-a648-3b5b-e063-6394a90aa4df | 2025-10-20 | Warnings | M003 |
| PROHEAL ALCOHOL XXL PREP PADS | ISOPROPYL ALCOHOL | Click Industries LLC | ec81be59-94a5-4675-9047-e3e82d7ad761 | 2025-10-20 | Warnings | M003 |
| ALCOHOL PREP PAD | ISOPROPYL ALCOHOL | Guangdong Comfort Medical Products Co., Ltd. | 3a2dea43-8123-3fb7-e063-6294a90a5e50 | 2025-10-19 | Warnings | M003 |
| ANTISEPTIC WIPE | BENZALKONIUM CHLORIDE | Guangdong Comfort Medical Products Co., Ltd. | 3a40a31d-4032-71ba-e063-6294a90a48dc | 2025-10-19 | Warnings | M003 |
| ANTIBACTERIAL BANDAGES | BENZALKONIUM CHLORIDE | Guangdong Comfort Medical Products Co., Ltd. | 6e43b8b3-2d49-8f76-e053-2a91aa0affb0 | 2025-10-19 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Soft Berry | ETHYL ALCOHOL 70% V/V | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 418fed84-d4ab-7352-e063-6294a90a6dab | 2025-10-19 | Warnings | M003 |
| BZK CLEANSER | BENZALKONIUM CHLORIDE | Geri-Gentle Corporation | 415eb5fb-5f88-d2dd-e063-6394a90abe5d | 2025-10-17 | Warnings | M003 |
| Medline Alcohol Prep Sterile, Large | ISOPROPYL ALCOHOL | Medline Industries, LP | c9fae7b6-2f4b-490b-9b17-a7297e738069 | 2025-10-16 | Warnings | M003 |
| Medline Alcohol Prep Sterile, Medium | ISOPROPYL ALCOHOL | Medline Industries, LP | 9a8584e1-b422-4b77-8464-4e022d578fad | 2025-10-16 | Warnings | M003 |
| Signature Select Pain Relieving | LIDOCAINE HCL, BENZALKONIUM CHLORIDE | Safeway/Albartsons | 3cab1b0c-4ffd-9c01-e063-6294a90ad15d | 2025-10-16 | Warnings | M003 |
| Medline Alcohol Prep | ISOPROPYL ALCOHOL | Medline Industries, LP | b43c0bff-82f8-c18d-e053-2995a90a8716 | 2025-10-16 | Warnings | M003 |
| Medline | BENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDE | Medline Industries, LP | b1059e68-b240-056c-e053-2995a90a61b2 | 2025-10-16 | 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 |