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 |
|---|---|---|---|---|---|---|
| Universal Rubbing Alcohol | ISOPROPYL ALCOHOL | Universal Distribution Center LLC | 183efdc2-cf3e-4f06-b292-0cfd097418b3 | 2026-02-23 | Warnings | M003 |
| Konix Povidone Iodine Topical Antiseptic | POVIDONE-IODINE | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS | 0cc6b001-4982-40ee-a476-151f86c14a8e | 2026-02-19 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Save-A-Lot Food Stores Ltd | e279b23d-6779-4f04-a93c-1c2a49559639 | 2026-02-19 | Warnings, Adverse reactions | M003 |
| First Aid Antiseptic | POVIDONE-IODINE | Meijer, Inc. | 193292da-390b-4430-91b1-1d159ac50507 | 2026-02-19 | Warnings, Adverse reactions | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Meijer, Inc. | 4989f1cd-4555-405a-a5f8-8714d472983c | 2026-02-19 | Warnings, Adverse reactions | M003 |
| First Aid Antiseptic | POVIDONE-IODINE | Target Corporation | 78693ec1-d725-408c-bb95-2261faad84ac | 2026-02-18 | Warnings, Adverse reactions | M003 |
| Travel Wipes Fresh Citrus Scent | ALCOHOL | SINGULAR ENTERPRISES LLC | ea77be5e-7c69-4787-b39a-4753b002dbbd | 2026-02-18 | Warnings | M003 |
| Travel Wipes Unscented | ISOPROPYL ALCOHOL | SINGULAR ENTERPRISES LLC | dd046146-fda7-438c-98ca-96ea1dd0ae0b | 2026-02-18 | Warnings | M003 |
| Benzalkonium chloride | FIRST AID ANTISEPTIC FOAM | Target Corporation | 4599eb25-2877-fc62-e063-6294a90a5d18 | 2026-02-18 | Warnings, Adverse reactions | M003 |
| Konix Povidone Iodine Topical Antiseptic | POVIDONE-IODINE | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS | 8a9848b0-19df-455a-9984-5ea2e5ce1b9f | 2026-02-17 | Warnings | M003 |
| Wintergreen 91 - Iron Lab | ETHYL ALCOHOL | Iron Lab SA de CV | 323a0717-0d61-c911-e063-6394a90a4854 | 2026-02-17 | Warnings | M003 |
| Ethyl Rubbing Alcohol | ALCOHOL | Iron Lab SA de CV | 323b2f5d-34b9-8f5b-e063-6394a90a59d5 | 2026-02-17 | Warnings | M003 |
| 50 Ethyl Rubbing Alcohol | ALCOHOL | Iron Lab SA de CV | 323b7ff8-91ce-c7a4-e063-6394a90a69fc | 2026-02-17 | Warnings | M003 |
| 70 Alcohol Hand Sanitizer | ALCOHOL | Iron Lab SA de CV | 323c06d5-c984-39b8-e063-6294a90a0d3f | 2026-02-17 | Warnings | M003 |
| 50 Wintergreen Alcohol | ALCOHOL | Iron Lab SA de CV | 323baeb1-e3ee-ec70-e063-6294a90a30f0 | 2026-02-17 | Warnings | M003 |
| 70 Rubbing Ethyl Alcohol | ALCOHOL | Iron Lab SA de CV | 323be8b4-4588-e2a6-e063-6394a90ab68b | 2026-02-17 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | United Natural Foods, Inc. dba UNFI | 8a44aa29-58d6-4971-b572-4579f03ed227 | 2026-02-17 | Warnings, Adverse reactions | M003 |
| INSTACLEAN HAND SANITIZING | ALCOHOL | SHIELD LINE LLC | 6d606fae-d95e-cffc-e053-2991aa0a988b | 2026-02-17 | Warnings | M003 |
| Burn Cream | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Trifecta Pharmaceuticals USA LLC | 087ac43c-1076-d1e2-e063-6294a90a5859 | 2026-02-16 | Warnings | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Valu Merchandisers Company | a631c976-cb9b-4099-8630-2a10c14bd3bd | 2026-02-16 | 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 |