# Guaifenesin and Dextromethorphan HBr by INNOVUS PHARMACEUTICALS, INC.: new human otc drug listing

**Launch Signal Score:** 40/100

| Field | Value |
|---|---|
| Product | Guaifenesin and Dextromethorphan HBr |
| Generic name | Guaifenesin and Dextromethorphan HBr |
| NDC | 57483-114 |
| Labeler | INNOVUS PHARMACEUTICALS, INC. |
| Product type | HUMAN OTC DRUG |
| Approval pathway | ANDA |
| Application number | ANDA206941 |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active ingredients | GUAIFENESIN 1200 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 60 mg/1 |
| Marketing start | 2026-10-27 |
| Package configurations | 1 |

## Why this score
- New generic entry: wholesalers and GPOs re-bid contracts.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=57483-114). Last refreshed: 2026-11-04T18:12:05.743Z.
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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.