# BRYTLY (Apraclonidine Hydrochloride) by Alcon Laboratories, Inc.: new human otc drug listing

**Launch Signal Score:** 45/100

| Field | Value |
|---|---|
| Product | BRYTLY |
| Generic name | Apraclonidine Hydrochloride |
| NDC | 0065-8596 |
| Labeler | Alcon Laboratories, Inc. |
| Product type | HUMAN OTC DRUG |
| Approval pathway | NDA |
| Application number | NDA220341 |
| Dosage form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active ingredients | APRACLONIDINE HYDROCHLORIDE 1.25 mg/mL |
| Marketing start | 2026-10-16 |
| Package configurations | 3 |

## Why this score
- Brand or biologic launch.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=0065-8596). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.