# Claravie (Miconazole Nitrate 2%) by Gentell LLC: new human otc drug listing

**Launch Signal Score:** 15/100

| Field | Value |
|---|---|
| Product | Claravie |
| Generic name | Miconazole Nitrate 2% |
| NDC | 61554-316 |
| Labeler | Gentell LLC |
| Product type | HUMAN OTC DRUG |
| Approval pathway | OTC MONOGRAPH DRUG |
| Application number | M005 |
| Dosage form | POWDER |
| Route | TOPICAL |
| Active ingredients | MICONAZOLE NITRATE 2 g/100g |
| Marketing start | 2026-10-09 |
| Package configurations | 1 |

## Why this score


Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=61554-316). Last refreshed: 2026-11-03T18:09:00.764Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.