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 |
|---|---|---|---|---|---|---|
| Isopropyl alcohol 91 percent | ISOPROPYL ALCOHOL | P & L Development, LLC | fcda76cb-63c4-4e81-9e0a-13be506a8150 | 2026-06-17 | Warnings | M003 |
| Novo Wipe | NOVO WIPE | SHENZHEN BENLIJU BIO-TECH CO.,LTD | 545c6386-139e-cb9b-e063-6394a90a0456 | 2026-06-16 | Warnings | M003 |
| 70% | ISOPROPYL ALCOHOL | Meijer, Inc. | 7b1f93ff-5eeb-4da1-8f02-7c47d713689a | 2026-06-15 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Meijer, Inc. | 531cea18-9609-4d78-876d-3ba5d2d1e16f | 2026-06-15 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Meijer, Inc. | b0d302c2-58a0-4c3e-9c4a-fd34de40c034 | 2026-06-15 | Warnings, Adverse reactions | M003 |
| Antiseptic | BENZALKONIUM CHLORIDE, BENZOCAINE | Wildman Business Group | 1fd15b91-6b81-d0bd-e063-6294a90a4d27 | 2026-06-15 | Warnings | M003 |
| GLOBAL CARE GOLD ANTIBACTERIAL HAND | BENZALKONIUM CHLORIDE | NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. | 540bde3c-5af2-456a-e063-6294a90aa774 | 2026-06-12 | Warnings | M003 |
| Smart Care Hand Sanitizer Fall Scents-Apple | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 541a09b6-2928-9fbf-e063-6394a90a3c4d | 2026-06-12 | Warnings | M003 |
| Smart Care Hand Sanitizer Holiday-Spiced Cranberry | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 541a41cf-5c63-c6fc-e063-6294a90abfcc | 2026-06-12 | Warnings | M003 |
| Smart Care Hand Sanitizer Holiday-Mistletoe | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 541a8aa9-1d4b-28ec-e063-6294a90aa34e | 2026-06-12 | Warnings | M003 |
| Hand Sanitizer | ALCOHOL | Guangdong Yanze Biotechnology Co., Ltd. | 5211ec31-90bc-e0fc-e063-6294a90a76ed | 2026-06-11 | Warnings | M003 |
| Smart Care Squishmallows Hand Sanitizer | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 53f5d658-dd1a-bb8e-e063-6294a90adbb1 | 2026-06-11 | Warnings | M003 |
| Smart Care Hand Sanitizer Fall Scents-Pumpkin Spice | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 53f6c000-849b-0045-e063-6294a90aa2f1 | 2026-06-11 | Warnings | M003 |
| EVR Alcohol Prep Pads | LSOPROPYL ALCOHOL | JINHUA JINGDI MEDICAL SUPPLIES CO.,LTD | 5406ba2f-6729-b9e7-e063-6394a90ac553 | 2026-06-11 | Warnings | M003 |
| MISTIFY FROSTY CANDY HAND SANITIZER | ALCOHOL ANTISEPTIC | Kingkey MBC Life Technology Group Co.,Ltd | 53e4f854-750b-7322-e063-6294a90a1110 | 2026-06-10 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 53ea8cec-bf36-4eec-e063-6394a90a559c | 2026-06-10 | Warnings | M003 |
| Isopropyl alcohol | ISOPROPYL ALCOHOL | CVS PHARMACY, INC | b30468f6-7a1b-4165-916f-36df21eb10e5 | 2026-06-09 | Warnings | M003 |
| Benzethonium chloride and Dyclonine hydrochloride | LIQUID BANDAGE | Chain Drug Marketing Association | 34062b23-52aa-99ae-e063-6294a90ae73f | 2026-06-09 | Warnings | M003 |
| Benzethonium chloride Plus Dyclonine hydrochloride | LIQUID BANDAGE | Chain Drug Marketing Association | 2419c9f9-3e15-4d0e-b422-a6110281fd1d | 2026-06-09 | Warnings | M003 |
| Smart Care Assorted Hand Sanitizer Pumpkin Spice | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 53dd3d76-81c9-ed6b-e063-6394a90aaea3 | 2026-06-09 | 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 |