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Data updated: Mar 10, 2026

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE
Approved 2006-12-07
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
19
Years on Market

Details

Status
Prescription
First Approved
2006-12-07
Routes
ORAL
Dosage Forms
SYRUP

Companies

GENUS Hikma
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE , PROMETHAZINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE Approval History

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What PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE Treats

8 indications

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE is approved for 8 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Cough
  • Nasal Congestion
  • Pain
  • Sore Throat
  • Headache
  • Runny Nose
  • Sneezing
  • Fever
Source: FDA Label

Drugs Similar to PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

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8 shared
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Shared indications:
CoughNasal CongestionPain +5 more
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
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CoughNasal CongestionPain +5 more
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ENCUBE
Shared indications:
Nasal CongestionRunny NoseSneezing
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
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3 shared
Teva
Shared indications:
Nasal CongestionRunny NoseSneezing
RHINOCORT
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KENVUE BRANDS
Shared indications:
Nasal CongestionRunny NoseSneezing
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3 shared
AstraZeneca
Shared indications:
Nasal CongestionRunny NoseSneezing
ALLZITAL
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Shared indications:
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ANAPROX DS
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ATNAHS PHARMA US
Shared indications:
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ANEXSIA 5/325
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2 shared
SPECGX LLC
Shared indications:
HeadacheFever
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Key Completed Trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE FDA Label Details

Pro

Indications & Usage

Uses temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help your child get to sleep

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Data Sources

FDA Approval: ANDA040654 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.