# Pepcid Complete Dual Action Berry Flavor (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) by Jones Healthcare Group - Packaging Services, Inc: new human otc drug listing

**Launch Signal Score:** 45/100

| Field | Value |
|---|---|
| Product | Pepcid Complete Dual Action Berry Flavor |
| Generic name | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE |
| NDC | 67414-700 |
| Labeler | Jones Healthcare Group - Packaging Services, Inc |
| Product type | HUMAN OTC DRUG |
| Approval pathway | NDA |
| Application number | NDA020958 |
| Dosage form | TABLET |
| Route | ORAL |
| Active ingredients | FAMOTIDINE 10 mg/1; CALCIUM CARBONATE 800 mg/1; MAGNESIUM HYDROXIDE 165 mg/1 |
| Pharmacologic class | Histamine-2 Receptor Antagonist [EPC] |
| Marketing start | 2026-07-30 |
| Package configurations | 1 |

## Why this score
- Brand or biologic launch.
- Class: Histamine-2 Receptor Antagonist [EPC].

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=67414-700). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.