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 01 | ALCOHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 56a3ad5f-c34a-6b90-e063-6394a90a06e9 | 2026-07-19 | Warnings | M003 |
| Hand Sanitizer | ETHYL ALCOHOL | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56ca8257-6537-fb4e-e063-6294a90a4916 | 2026-07-17 | Warnings | M003 |
| Antibacterial Hand Sanitizer Spray. | ETHYL ALCOHOL | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56caf683-bdf1-95e6-e063-6294a90a14d0 | 2026-07-17 | Warnings | M003 |
| Hand Sanitizer | ETHYL ALCOHOL | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56cbbfcf-3239-7c76-e063-6394a90a75b0 | 2026-07-17 | Warnings | M003 |
| Hand Sanitizer | ETHYL ALCOHOL | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56cd0c67-20dd-6783-e063-6294a90ae910 | 2026-07-17 | Warnings | M003 |
| Alcohol Free Hand Sanitizer | BENZALKONIUM CHLORIDE | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56cd55ee-b8ba-ddb9-e063-6394a90a1edc | 2026-07-17 | Warnings | M003 |
| FoamyiQ Non-Alcohol Hand Sanitizer | FOAMYIQ NON-ALCOHOL HAND SANITIZER | Spartan Chemical Company | ee8a2af2-0572-19b1-e053-2995a90a23ae | 2026-07-17 | Warnings | M003 |
| Non -Alcohol Grape Scented Hand Sanitizer | BENZALKONIUM CHLORIDE | Shenzhen Lantern Scicence Co.,Ltd. | 56b5c19e-cce5-16f8-e063-6394a90a1cbd | 2026-07-16 | Warnings | M003 |
| Non -Alcohol Cherry Scented Hand Sanitizer | BENZALKONIUM CHLORIDE | Shenzhen Lantern Scicence Co.,Ltd. | 56b643ec-9433-9f19-e063-6294a90a5f22 | 2026-07-16 | Warnings | M003 |
| Non -Alcohol Blueberry scented Hand sanitizer | BENZALKONIUM CHLORIDE | Shenzhen Lantern Scicence Co.,Ltd. | 56b67ff4-5785-106e-e063-6294a90af4ec | 2026-07-16 | Warnings | M003 |
| Hand Sanitizer | ETHYL ALCOHOL | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56b733b1-8a15-0767-e063-6294a90af16b | 2026-07-16 | Warnings | M003 |
| Hand sanitizer | HAND SANITIZER SPRAY | Beimei Biotechnology (Guangzhou) Co., Ltd. | 56a22363-f531-d9bd-e063-6294a90a020b | 2026-07-15 | Warnings | M003 |
| Non -Alcohol Peach Scented Hand Sanitizer | BENZALKONIUM CHLORIDE | Shenzhen Lantern Scicence Co.,Ltd. | 56b26868-833c-3d72-e063-6394a90aea4f | 2026-07-15 | Warnings | M003 |
| Hand sanitizer | HAND SANITIZER SPRAY | Beimei Biotechnology (Guangzhou) Co., Ltd. | 568f791d-d6c3-7092-e063-6294a90a4b52 | 2026-07-14 | Warnings | M003 |
| Hand sanitizer 8oz with vitamin E | ETHYL ALCOHOL 70% | REJOICE INTERNATIONAL CORP. | 03f4a507-df3f-e265-e063-6294a90acd11 | 2026-07-13 | Warnings | M003 |
| Hand sanitizer 8oz with aloe vera | ETHYL ALCOHOL 70% | REJOICE INTERNATIONAL CORP. | 03f81b63-2b08-77b1-e063-6294a90afeba | 2026-07-13 | Warnings | M003 |
| Scentfull Hand Sanitizer Pink Champagne | ALCOHOL | Scent Theory Products LLC | 565650e6-e5f9-c010-e063-6394a90aacfa | 2026-07-11 | Warnings | M003 |
| Scentfull Hand Sanitizer Blue Driftwood | ALCOHOL | Scent Theory Products LLC | 56572ebe-d624-6389-e063-6394a90a23b4 | 2026-07-11 | Warnings | M003 |
| Humco Gentian Violet 1% | GENTIAN VIOLET 1% | Humco Holding Group, Inc. | 7b4e6572-cb44-491d-8063-f7519307a8e5 | 2026-07-09 | Warnings | M003 |
| Gentian Violet 1% | GENTIAN VIOLET 1% | Pharma Nobis, LLC | e42fa7d2-47ef-0e82-e053-2995a90a67c5 | 2026-07-09 | 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 |