# COLGATE OPTIC WHITE SENSITIVITY RELIEF SOOTHING MINT (SODIUM FLUORIDE, POTASSIUM NITRATE) by Colgate-Palmolive Company: new human otc drug listing

**Launch Signal Score:** 15/100

| Field | Value |
|---|---|
| Product | COLGATE OPTIC WHITE SENSITIVITY RELIEF SOOTHING MINT |
| Generic name | SODIUM FLUORIDE, POTASSIUM NITRATE |
| NDC | 35000-093 |
| Labeler | Colgate-Palmolive Company |
| Product type | HUMAN OTC DRUG |
| Approval pathway | OTC MONOGRAPH DRUG |
| Application number | M022 |
| Dosage form | PASTE, DENTIFRICE |
| Route | DENTAL |
| Active ingredients | SODIUM FLUORIDE 1.1 mg/g; POTASSIUM NITRATE 50 mg/g |
| Marketing start | 2026-09-18 |
| 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=35000-093). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.