# NIGHTTIME COLD AND FLU (Acetaminophen, Dextromethorphan HBr, Doxylamine succinate) by Amazon.com Services LLC: new human otc drug listing

**Launch Signal Score:** 15/100

| Field | Value |
|---|---|
| Product | NIGHTTIME COLD AND FLU |
| Generic name | Acetaminophen, Dextromethorphan HBr, Doxylamine succinate |
| NDC | 72288-322 |
| Labeler | Amazon.com Services LLC |
| Product type | HUMAN OTC DRUG |
| Approval pathway | OTC MONOGRAPH DRUG |
| Application number | M012 |
| Dosage form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active ingredients | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 |
| Marketing start | 2026-09-24 |
| 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=72288-322). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.