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 |
|---|---|---|---|---|---|---|
| Povidone Iodine Swabstick | POVIDONE IODINE 10% | Trifecta Pharmaceuticals USA LLC | 59f82f9d-8c39-6890-e063-6294a90a090e | 2026-08-26 | Warnings | M003 |
| Gentian Violet | GENTIAN VIOLET | Vitamex USA, Corp | 21742061-fc0b-f750-e063-6394a90a7508 | 2026-08-26 | Warnings | M003 |
| Mercurochrome | BENZALKONIUM CHLORIDE | Vitamex USA, Corp | 21652b11-715d-0c54-e063-6294a90a8855 | 2026-08-26 | Warnings | M003 |
| Scentsational Square Hand Sanitizer | HAND SANITIZER | Raining Rose, Inc. | 59f9bacf-80dc-3468-e063-6294a90a0ae1 | 2026-08-26 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59fa27b4-dfd4-720b-e063-6394a90af659 | 2026-08-26 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59fb22d6-f6a4-42cd-e063-6394a90a859a | 2026-08-26 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59fbb054-461e-aa6e-e063-6394a90a470c | 2026-08-26 | Warnings | M003 |
| Curad Alcohol Sterile, Thick | ISOPROPYL ALCOHOL | Medline Industries, LP | b769898e-a73f-4323-af15-bee8dbe455b6 | 2026-08-25 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Your Military Exchanges | a71734c6-6b92-4d3d-84d1-a07f592fa828 | 2026-08-25 | Warnings, Adverse reactions | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59e742a6-61f9-59f7-e063-6394a90a8738 | 2026-08-25 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59e7dfb1-49b5-d2be-e063-6394a90a04d8 | 2026-08-25 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59d3c369-86aa-8ebd-e063-6394a90aa806 | 2026-08-24 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59d7fc3c-3a93-153d-e063-6394a90ac647 | 2026-08-24 | Warnings | M003 |
| Be Smart Get Prepared Hand Sanitizer | ALCOHOL | Total Resources International, Inc | 23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e | 2026-08-24 | Warnings | M003 |
| Claravie | BENZALKONIUM CHLORIDE | Gentell LLC | 59887af3-9b22-9664-e063-6294a90a57c6 | 2026-08-21 | Warnings | M003 |
| hand sanitizer- light blue 01 | ALCOHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 598a96f0-33fe-40aa-e063-6394a90aeacb | 2026-08-21 | Warnings | M003 |
| hand sanitizer- light green 01 | ALCOHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 598a165a-90ff-e00c-e063-6394a90a3351 | 2026-08-21 | Warnings | M003 |
| Family Beauty Antibacterial Hand Wipes | BENZALKONIUM CHLORIDE | Zhejiang Bright Care Co., Ltd. | 6ff604f7-4011-4f0e-aa2d-a46e1a973d13 | 2026-08-21 | Warnings | M003 |
| hand sanitizer- light purple 01 | ALCOHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 598b7bb8-0d2e-a66f-e063-6294a90a45b8 | 2026-08-21 | Warnings | M003 |
| hand sanitizer- light yellow 01 | ALCOHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 598bf8cd-2a79-8b56-e063-6394a90a42a8 | 2026-08-21 | 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 |