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 Hand Sanitizer Coconut Breeze | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 47af27a7-3df9-270a-e063-6394a90abc7d | 2026-01-05 | Warnings | M003 |
| Hand Sanitiser | ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | a44d82bf-68a3-56bc-e053-2995a90ae526 | 2026-01-05 | Warnings | M003 |
| Green Island Sanitiser | ALCOHOL | Zhejiang Guoyao Aerosol Co., Ltd | a7d1df16-3566-badf-e053-2a95a90aa61a | 2026-01-05 | Warnings | M003 |
| Green Island | ETHYL ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | a7443a72-6ee5-07f7-e053-2995a90a3341 | 2026-01-05 | Warnings | M003 |
| SHABOINK | ETHYL ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | a8bc5da3-8660-6343-e053-2995a90ac905 | 2026-01-05 | Warnings | M003 |
| SHABOINK | ETHYL ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | a8c0c9ce-05ac-0f33-e053-2a95a90ab8ed | 2026-01-05 | Warnings | M003 |
| H2One | ETHYL ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | a9bcecf7-7767-69b4-e053-2995a90a9247 | 2026-01-05 | Warnings | M003 |
| Smart Care Hand Sanitizer Mermicorno | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 47af97d6-ae84-adfe-e063-6394a90aa777 | 2026-01-05 | Warnings | M003 |
| Healing Solutions | ETHYL ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | a9bf73d9-9eb2-5e12-e053-2995a90a0332 | 2026-01-05 | Warnings | M003 |
| PFA | ETHYL ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | bc91087d-5976-e922-e053-2995a90ae2ac | 2026-01-05 | Warnings | M003 |
| American Red Cross 70% Ethyl Alcohol Hand Sanitizer | ETHYL ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd | f6bf5c5a-4954-4030-e053-6394a90a9cba | 2026-01-05 | Warnings | M003 |
| Hand sanitizer 8oz with vitamin E | ETHYL ALCOHOL 70% | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 03f88721-92a5-1453-e063-6294a90a1591 | 2026-01-05 | Warnings | M003 |
| Hand sanitizer 16.9oz with vitamin E | ETHYL ALCOHOL 70% | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 04064c4d-e810-28ff-e063-6394a90a3983 | 2026-01-05 | Warnings | M003 |
| Hand sanitizer 8oz with aloe vera | ETHYL ALCOHOL 70% | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 04064b0b-6f21-9ca4-e063-6294a90a85e2 | 2026-01-05 | Warnings | M003 |
| Hand sanitizer 2oz 2pk lavender | ETHYL ALCOHOL 70% | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 05204974-88f3-84ce-e063-6394a90a326b | 2026-01-05 | Warnings | M003 |
| Hand sanitizer 2oz 2pk with aloe vera | ETHYL ALCOHOL 70% | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 04fe378d-ee1e-ad52-e063-6294a90ae146 | 2026-01-05 | Warnings | M003 |
| Hand sanitizer 2oz 2pk lemon | ETHYL ALCOHOL 70% | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 04fe16d8-1824-34fe-e063-6394a90a7ab1 | 2026-01-05 | Warnings | M003 |
| Hand sanitizer 16.9oz with vitamin E | ETHYL ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 0fbc45c1-c7e8-bded-e063-6394a90a31d1 | 2026-01-05 | Warnings | M003 |
| Smart Care Hand Sanitizer Monster Jam | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 47afe5bd-5e06-7300-e063-6294a90a94e8 | 2026-01-05 | Warnings | M003 |
| Walgreens Hand Sanitizer watermelon | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 479b898c-0dff-98fe-e063-6294a90ade20 | 2026-01-04 | 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 |