United States · FDA National Drug Code directory
Promethazine Hydrochloride and Phenylephrine Hydrochloride
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 65162-679_1cd384c6-b844-40d6-84bf-cdea9bbd334a
- Product NDC
- 65162-679
- Form
- SOLUTION
- Composition / generic term
- Promethazine and Phenylephrine
- Labeler
- Amneal Pharmaceuticals LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20090825
- Source listing expiry
- 20261231
Source-listed ingredients
- PROMETHAZINE HYDROCHLORIDE — 6.25 mg/5mL
- PHENYLEPHRINE HYDROCHLORIDE — 5 mg/5mL
These values do not establish equivalence or a dose recommendation.
Packages
- 118 mL in 1 BOTTLE (65162-679-86) · 65162-679-86
- 473 mL in 1 BOTTLE (65162-679-90) · 65162-679-90
Source and coverage
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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
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