BerbereX Wound Cleanser
- Product NDC
- 52261-0500
- 11-digit product format
- 522610500
- Labeler code
- 52261
- Product ID
- 52261-0500_d3e2c5a1-5f63-4c96-8fbe-1ba6c8c5d93d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzethonium Chloride
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Cosco International, Inc.
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-05-17
- Substance
- ALLANTOIN; BENZETHONIUM CHLORIDE
- Active strength
- 5; 1 g/1000mL; g/1000mL
- 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 | 52261-0500-2 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52261-0500-3 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52261-0500-1 | 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 | 52261-0500-2 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52261-0500-3 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52261-0500-1 | 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 | 52261-0500-2 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52261-0500-3 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52261-0500-1 | 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 | 52261-0500-2 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52261-0500-3 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52261-0500-1 | 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 | 52261-0500-3 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52261-0500-1 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52261-0500-2 | 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 | 52261-0500-3 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52261-0500-1 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52261-0500-2 | 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 | 52261-0500-3 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52261-0500-1 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52261-0500-2 | 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 Cleanser
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALLANTOIN | 5 g/1000mL |
| BENZETHONIUM CHLORIDE | 1 g/1000mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 344S277G0Z | Internal UNII lookup |
| PH41D05744 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 08b28f52-21fc-4694-a163-91c8193b4008 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 52261-0500-1 | 2025-03-28 | Drug Facts |
| 52261-0500-2 | 2025-03-28 | Drug Facts |
| 52261-0500-3 | 2025-03-28 | Drug Facts |
| 52261-0500-1 | 2025-01-30 | Drug Facts |
| 52261-0500-2 | 2025-01-30 | Drug Facts |
| 52261-0500-3 | 2025-01-30 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52261-0500-1 | BerbereX Wound Cleanser | 118 mL in 1 BOTTLE, SPRAY | LIQUID | 118 | 7 | |
| 52261-0500-2 | BerbereX Wound Cleanser | 237 mL in 1 BOTTLE, SPRAY | LIQUID | 237 | 7 | |
| 52261-0500-3 | BerbereX Wound Cleanser | 473 mL in 1 BOTTLE, SPRAY | LIQUID | 473 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52261-0500 | BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20250331_08b28f52-21fc-4694-a163-91c8193b4008.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1437628 | allantoin 0.5 % / benzethonium chloride 0.1 % Topical Solution | PSN | 08b28f52-21fc-4694-a163-91c8193b4008 | 7 |
| 1487627 | BerbereX Wound Cleanser 0.5 % / 0.1 % Topical Solution | PSN | 08b28f52-21fc-4694-a163-91c8193b4008 | 7 |
| 1487627 | allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution [Berberex Wound Cleanser] | SBD | 08b28f52-21fc-4694-a163-91c8193b4008 | 7 |
| 1437628 | allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution | SCD | 08b28f52-21fc-4694-a163-91c8193b4008 | 7 |
| 1437628 | allantoin 0.5 % / benzethonium chloride 0.1 % Topical Solution | SY | 08b28f52-21fc-4694-a163-91c8193b4008 | 7 |
| 1487627 | Berberex Wound Cleanser (allantoin 0.5 % / benzethonium chloride 0.1 % ) Topical Solution | SY | 08b28f52-21fc-4694-a163-91c8193b4008 | 7 |
| 1487627 | Berberex Wound Cleanser (allantoin 5 MG/ML / benzethonium chloride 1 MG/ML) Topical Solution | SY | 08b28f52-21fc-4694-a163-91c8193b4008 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52261-0500-1 | 52261050001 | 118 mL in 1 BOTTLE, SPRAY (52261-0500-1) | 118 ml | 2015-08-24 | 0000-00-00 | No | No | Current |
| 52261-0500-2 | 52261050002 | 237 mL in 1 BOTTLE, SPRAY (52261-0500-2) | 237 ml | 2015-08-24 | 0000-00-00 | No | No | Current |
| 52261-0500-3 | 52261050003 | 473 mL in 1 BOTTLE, SPRAY (52261-0500-3) | 473 ml | 2015-08-24 | 0000-00-00 | No | No | Current |