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 | HAND SANITIZER SPRAY | Beimei Biotechnology (Guangzhou) Co., Ltd. | 49455156-1072-14f5-e063-6294a90abdff | 2026-01-26 | Warnings | M003 |
| Anti-bacterial Hand Wipes | ANTI-BACTERIAL HAND WIPES | Jinhua Aidi Daily Chemical Co., Ltd. | 494b09a4-4982-13bf-e063-6394a90a486f | 2026-01-26 | Warnings | M003 |
| Homworks Alcohol Wipes Multipurpose | ETHYL ALCOHOL | Acadian Crossing Consumer Products, LLC. | c9f0c3b3-5f39-dfa6-e053-2995a90a7644 | 2026-01-26 | Warnings | M003 |
| BZK Pads | BENZALKONIUM CHLORIDE | Dynarex Corporation | 87288939-cc34-4437-94ab-dcb997d6acd5 | 2026-01-23 | Warnings | M003 |
| BZK Pads | BENZALKONIUM CHLORIDE | Dynarex Corporation | 10454042-ff2e-44ce-b2e2-436cc004897f | 2026-01-23 | Warnings | M003 |
| Everlit Survival Sting Relief Pad | ISOPROPYL ALCOHOL | EVERLIT GLOBAL INC. | 3a0414ea-f862-aa0f-e063-6294a90aecb7 | 2026-01-23 | Warnings | M003 |
| Medline | POVIDONE-IODINE | Medline Industries, LP | 48ebfdd6-d346-7e26-e063-6394a90af11a | 2026-01-23 | Warnings | M003 |
| EVERLIT SURVIVAL IODINE PREP PADS | POVIDONE-IODINE | EVERLIT GLOBAL INC. | 3a03fc8d-2653-9183-e063-6294a90ad76e | 2026-01-23 | Warnings | M003 |
| EVERLIT SURVIVAL PREP PAD | ISOPROPYL ALCOHOL | EVERLIT GLOBAL INC. | 3a03ed81-5b1d-172e-e063-6394a90ac59c | 2026-01-23 | Warnings | M003 |
| Everlit Survival Antiseptic Wipe | ANTISEPTIC WIPE | EVERLIT GLOBAL INC. | 3a03f7e6-cc74-22a2-e063-6394a90a5f9f | 2026-01-23 | Warnings | M003 |
| Rite Aid Isopropyl Alcohol Wipes | ISOPROPYL ALCOHOL | Rite Aid | bca837b0-5044-4e97-e053-2a95a90a13af | 2026-01-22 | Warnings | M003 |
| Drs. Pharmacy Triple Antibiotic AND BURN RELIEF | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | OL PHARMA TECH, LLC Drs PHARMACY | 4928d9dd-542b-fe8b-e063-6294a90a9252 | 2026-01-22 | Warnings | M003 |
| DOP Ethyl Alcohol 70% | ETHYL ALCOHOL | Omega & Delta Co., Inc. | b96d85f8-739c-4b96-9dd5-8119ebf66c9f | 2026-01-21 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Rose Lychee | ETHYL ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 48dfcbe1-8e0c-1715-e063-6394a90a733f | 2026-01-21 | Warnings | M003 |
| Lights Povindone Iodine Swabstick | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 977b6077-bf47-4e02-bde4-c752e73d7628 | 2026-01-21 | Warnings | M003 |
| Lights Povindone Iodine Scrub | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 000bf57b-1805-4746-bf1c-32856241213a | 2026-01-21 | Warnings | M003 |
| Lights Povidone Iodine Solution | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 6946eb98-6870-4b21-9dda-b01a8adab84b | 2026-01-21 | Warnings | M003 |
| Lights Povidone Iodine Prep Pad | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | e561332d-e419-43db-a68e-0c0d49b01c9a | 2026-01-21 | Warnings | M003 |
| Lights Povindone Iodine Swabstick | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 2610fde4-4572-4d15-a970-f6d3beb734fe | 2026-01-21 | Warnings | M003 |
| Lights Povidone Iodine Solution | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 7d4a92be-0601-4256-bc5b-bc1b07d97bb7 | 2026-01-21 | 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 |