# phenylephrine hydrochloride, acetaminophen, dextromethorphan hydrobromide (phenylephrine hydrochloride, acetaminophen, dextromethorphan hydrobromide) by Bayer HealthCare LLC.: new drug for further processing listing

**Launch Signal Score:** 15/100

| Field | Value |
|---|---|
| Generic name | phenylephrine hydrochloride, acetaminophen, dextromethorphan hydrobromide |
| NDC | 0280-8295 |
| Labeler | Bayer HealthCare LLC. |
| Product type | DRUG FOR FURTHER PROCESSING |
| Approval pathway | DRUG FOR FURTHER PROCESSING |
| Dosage form | CAPSULE |
| Active ingredients | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 |
| Marketing start | 2026-07-01 |
| 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=0280-8295). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.