# Acetaminophen Diphenhydramine HCL by Dr. Reddy's Laboratories Inc.: new human otc drug listing

**Launch Signal Score:** 15/100

| Field | Value |
|---|---|
| Product | Acetaminophen Diphenhydramine HCL |
| Generic name | Acetaminophen Diphenhydramine HCL |
| NDC | 75907-431 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Product type | HUMAN OTC DRUG |
| Approval pathway | OTC MONOGRAPH DRUG |
| Application number | M013 |
| Dosage form | TABLET |
| Route | ORAL |
| Active ingredients | ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE 25 mg/1 |
| Marketing start | 2026-09-25 |
| Package configurations | 2 |

## 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=75907-431). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.