United Spirit of America
- Product NDC
- 58443-0523
- 11-digit product format
- 584430523
- Labeler code
- 58443
- Product ID
- 58443-0523_dfc6742d-a5ad-58e2-e053-2a95a90a7ff6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ethyl Alcohol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Prime Enterprises
- Application
- part333A
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2019-06-13
- Marketing end
- 0000-00-00
- Substance
- ALCOHOL
- Active strength
- 606 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58443-0523-3 | 58443052303 | 88.7 mL in 1 BOTTLE (58443-0523-3) | 88.7 ml | 2019-06-13 | 0000-00-00 | No | No | Current |
| 58443-0523-9 | 58443052309 | 3700 mL in 1 BOTTLE (58443-0523-9) | 3700 ml | 2019-06-13 | 0000-00-00 | No | No | Current |