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 |
|---|---|---|---|---|---|---|
| hand sanitizer- light pink 01 | ALCOHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 598c41f0-908d-df52-e063-6394a90a3c8d | 2026-08-21 | Warnings | M003 |
| Olimpo Antibacterial | BENZALKONIUM CHLORIDE 0.1% | Industria La Popular, S.A. | 597e3b3e-51f0-5fcf-e063-6394a90ac297 | 2026-08-20 | Warnings | M003 |
| Benzalkonium Chloride | BENZALKONIUM CHLORIDE TOWELETTES | Trifecta Pharmaceuticals USA LLC | 59811e67-57f0-4db1-e063-6294a90a2ad8 | 2026-08-20 | Warnings | M003 |
| inControl alcohol | ISOPROPYL ALCOHOL | H-E-B | 45dfbd7a-0ae1-4146-9527-5483c884e636 | 2026-08-18 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | The Kroger Co. | 52f6258f-4b4c-49f4-9bc7-40dc3918869d | 2026-08-17 | Warnings, Adverse reactions | M003 |
| 70% Isopropyl Rubbing Alcohol | ISOPROPYL RUBBING ALCOHOL | The Kroger Co. | b127bba1-ce0b-4142-8b7d-f12f062b0938 | 2026-08-17 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | The Kroger Co. | cd3f8779-9e57-4b23-a029-7424d4d4ab2a | 2026-08-17 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | The Kroger Co. | ca6c7f8a-d41a-4d77-817c-3dbdc40f890e | 2026-08-17 | Warnings, Adverse reactions | M003 |
| Alcohol Sanitizer Spray. | ETHYL ALCOHOL | Guangdong Yanze Biotechnology Co., Ltd. | 58fb9efe-43f0-1b7f-e063-6394a90a0145 | 2026-08-14 | Warnings | M003 |
| Povidone-Iodine | POVIDONE-IODINE | Major Pharmaceuticals | 59041ca3-a195-5a20-e063-6394a90a2ac9 | 2026-08-14 | Warnings | M003 |
| Alcohol Hand Sanitizer | ETHYL ALCOHOL | Guangdong Yanze Biotechnology Co., Ltd. | 58fa90dc-c3b5-787b-e063-6294a90a2e17 | 2026-08-13 | Warnings | M003 |
| SprinJene | ALCOHOL | Health and Natural Beauty USA Corp | 1853f023-f4db-4cd8-a4df-a439bc306cc3 | 2026-08-13 | Warnings | M003 |
| LUXURY IPA 70% | LUXURY ISOPROPYL ALCOHOL 70% 16OZ | TSM BRANDS LLC | 2240a9e0-dac5-54fa-e063-6394a90a35f5 | 2026-08-11 | Warnings | M003 |
| Ethyl alcohol | ETHYL ALCOHOL | Strategic Sourcing Services LLC | 4fec6f1f-0249-423f-bd3c-427aa6924c6f | 2026-08-10 | Warnings, Adverse reactions | M003 |
| antibacterial hand wipes (JUICY WATERMELON) | ANTIBACTERIAL HAND WIPES | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 5883c43d-212b-af39-e063-6394a90ad652 | 2026-08-08 | Warnings | M003 |
| LIGHTS Antiseptic and Pain Relieving Prep Pad | ISOPROPYL ALCOHOL | Lights Medical Manufacture Co., Ltd. | 91cc7334-f610-487d-a895-3dda78c3372e | 2026-08-07 | Warnings | M003 |
| CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSK | ETHYL ALCOHOL | CVS Pharmacy, Inc. | 60128fc3-b127-44ee-9e9b-384d322d213a | 2026-08-07 | Warnings | M003 |
| CVS Beauty Hydrating Hand Sanitizer Sea Salt and Lavender | ETHYL ALCOHOL | CVS Pharmacy, Inc. | 6c160826-ad98-4390-a07b-c92a2ae5b181 | 2026-08-07 | Warnings | M003 |
| antibacterial hand wipes (2257C) | ANTIBACTERIAL HAND WIPES (2257C) | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 585a1c36-7bdc-4d4f-e063-6394a90ad6d2 | 2026-08-06 | Warnings | M003 |
| antibacterial hand wipes (Angel) | ANTIBACTERIAL HAND WIPES | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 585c4a14-8dc9-3a08-e063-6394a90ab4f5 | 2026-08-06 | 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 |