# gas relief (simethicone) by BIONPHARMA INC.: new human otc drug listing

**Launch Signal Score:** 15/100

| Field | Value |
|---|---|
| Product | gas relief |
| Generic name | simethicone |
| NDC | 69452-581 |
| Labeler | BIONPHARMA INC. |
| Product type | HUMAN OTC DRUG |
| Approval pathway | OTC MONOGRAPH DRUG |
| Application number | M002 |
| Dosage form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active ingredients | DIMETHICONE 500 mg/1 |
| Marketing start | 2026-09-30 |
| 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=69452-581). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.