XtraCare Wet Wipes
- Product NDC
- 57337-062
- 11-digit product format
- 573370062
- Labeler code
- 57337
- Product ID
- 57337-062_2decd513-1fc5-1793-e063-6294a90a18bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzethonium Chloride
- Dosage form
- SWAB
- Route
- TOPICAL
- Labeler
- Rejoice International
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-03-13
- Substance
- BENZETHONIUM CHLORIDE
- Active strength
- 3 mg/100mg
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 57337-062-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 57337-062-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 57337-062-01 | 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
- XtraCare Wet Wipes
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZETHONIUM CHLORIDE | 3 mg/100mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| PH41D05744 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043348 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3741acc3-c590-4bf1-8c83-4f812e2c7adc | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57337-062-01 | 2025-02-12 | C162847 | 48780-1 | 2cef2736-8c1d-d83d-e063-dadaa90ab31f | XtraCare Wet Wipes |
| 57337-062-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8c1d-d83d-e063-dadaa90ab31f | XtraCare Wet Wipes |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57337-062-01 | XtraCare Wet Wipes | 100 mg in 1 APPLICATOR | SWAB | 100 | 3 | |
| 57337-062-01 | XtraCare Wet Wipes | 18 in 1 PACKAGE | SWAB | 18 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|
| 1043348 | benzethonium Cl 0.3 % Medicated Pad | PSN | 3741acc3-c590-4bf1-8c83-4f812e2c7adc | 3 |
| 1043348 | benzethonium chloride 3 MG/ML Medicated Pad | SCD | 3741acc3-c590-4bf1-8c83-4f812e2c7adc | 3 |
| 1043348 | benzethonium chloride 0.3 % Medicated Wipe | SY | 3741acc3-c590-4bf1-8c83-4f812e2c7adc | 3 |
| 1043348 | benzethonium chloride 0.3 % Topical Cloth | SY | 3741acc3-c590-4bf1-8c83-4f812e2c7adc | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57337-062-01 | 57337006201 | 18 APPLICATOR in 1 PACKAGE (57337-062-01) / 100 mg in 1 APPLICATOR | 18 applicator | 2014-03-13 | 0000-00-00 | No | No | Current |