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 |
|---|---|---|---|---|---|---|
| Up and Up Max Pain Relieving Cleansing | BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE | TARGET CORPORATION | 2c3e72eb-5d98-1f3f-e063-6394a90ab00c | 2025-01-21 | Warnings | M003 |
| Sierrasoft Clear Antibacterial Wash Foam | CHLOROXYLENOL | CWGC LA Inc. | 013a36fa-5a9a-46ea-b9d0-ac366257612e | 2025-01-20 | Warnings | M003 |
| TM TITUS MEDICAL ANTISEPTIC Non Sterile | POVIDONE-IODINE | Titus Medical LLC | 690b87d0-d889-43c6-b99e-cd9f26fd682a | 2025-01-17 | Warnings | M003 |
| TM Titus Medical Povidone Iodine | POVIDONE-IODINE | Titus Medical LLC | af7840c0-239e-4ff6-8d27-614e7d71ca99 | 2025-01-17 | Warnings | M003 |
| Smart Care Sanitizer Spray. 01 | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 1b125c5d-7041-c71b-e063-6394a90add9b | 2025-01-17 | Warnings | M003 |
| Berry Hand Sanitizer Spray. 01 | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 1f128054-4c57-8055-e063-6294a90adc4e | 2025-01-17 | Warnings | M003 |
| ROAME Moisturizing Hand Sanitizer Cloud 999 | ALCOHOL HAND SANITIZER | Roame LLC | 2bb1003e-8e4c-8dd8-e063-6294a90ad37d | 2025-01-14 | Warnings | M003 |
| Antiseptic Towelettes | BENZALKONIUM CHLORIDE | CMC Group Inc. | d7470f98-4278-415b-92e7-9eca2036bc09 | 2025-01-13 | Warnings | M003 |
| Alcohol Cleansing | ISOPROPYL ALCOHOL | CMC Group Inc. | e3985ef1-503a-4193-a5b5-7910aefa7814 | 2025-01-13 | Warnings | M003 |
| Antibiotic Application | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | CMC Group, Inc. | da436c35-a98f-4df7-9d23-885564734cef | 2025-01-13 | Warnings | M003 |
| Burn Treatment | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | CMC Group Inc. | 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40 | 2025-01-13 | Warnings | M003 |
| Hand Sanitizer | ALCOHOL | CMC Group Inc. | dcca50e6-0935-401d-a23e-be4d1231dde9 | 2025-01-13 | Warnings | M003 |
| Refill 2 | BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | CMC Group, Inc. | 45dde3f0-546c-4ec5-beb0-c3d0432f4983 | 2025-01-13 | Warnings | M003 |
| Refill 3 | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | CMC Group Inc. | e5cb395f-5037-4b0e-9c9d-2d78b5b01b25 | 2025-01-13 | Warnings | M003 |
| Refill 4 | ISOPROPYL ALCOHOL | CMC Group Inc. | 6f4a4538-7522-4bcf-b3cf-8dea60438a4d | 2025-01-13 | Warnings | M003 |
| Refill 6 | ALCOHOL, WATER | CMC Group, Inc. | 7849ae59-5484-4b86-a0b9-ec9b93d9afe0 | 2025-01-13 | Warnings | M003 |
| EVR Povidone lodine Wipe | POVIDONE LODINE | Changzhou Maokang Medical Products Co., Ltd. | 2b57e301-74e0-e1db-e063-6294a90a6c18 | 2025-01-10 | Warnings | M003 |
| EVR Sting Relief Wipe | BENZOCAINE, ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd. | 2b584d09-916c-00f8-e063-6294a90adbcf | 2025-01-10 | Warnings | M003 |
| Medzah Ditek Alcohol Prep Pads | ISOPROPYL ALCOHOL | Medzah Industries | 4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac | 2025-01-10 | Warnings | M003 |
| Alcohol Prep Pad-Large | ISOPROPYL ALCOHOL | Global Biomedical Technologies, LLC | 93d00515-e93f-48a3-b66b-7d933e734e54 | 2025-01-10 | 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 |