Promethazine and Phenylephrine HCl, and Codeine Phosphate
Active substance: PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, CODEINE PHOSPHATE
SYRUP · PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL, PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL, CODEINE PHOSPHATE 10 mg/5mL
United StatesActive
Marketing holder: Amneal Pharmaceuticals LLC
Verified 2026-10-09 · openFDA NDC
- Source: openFDA NDC
Composition
- PROMETHAZINE HYDROCHLORIDE · 6.25 mg/5mL
- PHENYLEPHRINE HYDROCHLORIDE · 5 mg/5mL
- CODEINE PHOSPHATE · 10 mg/5mL
Registration
- Registration number
- 65162-694
- Registration status
- Active
- Dispensing
- Prescription only
- Control marker
- CV
- Route
- ORAL
Sources
- product · openFDA NDC · 65162-694 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 65162-694 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 65162-694 · Verified 2026-10-09 · open in source
- ingredients.1 · openFDA NDC · 65162-694 · Verified 2026-10-09 · open in source
- ingredients.2 · openFDA NDC · 65162-694 · Verified 2026-10-09 · open in source