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Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

PHENYLEPHRINE HYDROCHLORIDE
Approved 2025-05-30
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-05-30
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Approval History

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What PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Treats

8 indications

PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is approved for 8 conditions since its original approval in 2025. 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 IN 0.9% SODIUM CHLORIDE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

IMMPHENTIV
PHENYLEPHRINE HYDROCHLORIDE
8 shared
Hikma
Shared indications:
CoughNasal CongestionPain +5 more
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
8 shared
GENUS
Shared indications:
CoughNasal CongestionPain +5 more
PROMETHAZINE W/ DEXTROMETHORPHAN
DEXTROMETHORPHAN HYDROBROMIDE
5 shared
PHARMOBEDIENT
Shared indications:
Nasal CongestionCoughHeadache +2 more
ADVAIR DISKUS 100/50
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
ADVAIR DISKUS 250/50
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
ADVAIR DISKUS 500/50
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
ASTEPRO
AZELASTINE HYDROCHRLORIDE
3 shared
MEDA PHARMS
Shared indications:
Nasal CongestionRunny NoseSneezing
BREZTRI AEROSPHERE
BUDESONIDE
3 shared
AstraZeneca
Shared indications:
Nasal CongestionRunny NoseSneezing
BUDESONIDE
BUDESONIDE
3 shared
Teva
Shared indications:
Nasal CongestionRunny NoseSneezing
ENTOCORT EC
BUDESONIDE
3 shared
PADAGIS US
Shared indications:
Nasal CongestionRunny NoseSneezing
FLOVENT DISKUS 100
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
FLOVENT DISKUS 250
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
FLOVENT DISKUS 50
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Nasal CongestionRunny NoseSneezing
FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE
3 shared
ENCUBE
Shared indications:
Nasal CongestionRunny NoseSneezing
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
FLUTICASONE PROPIONATE
3 shared
Teva
Shared indications:
Nasal CongestionRunny NoseSneezing
RHINOCORT
BUDESONIDE
3 shared
KENVUE BRANDS
Shared indications:
Nasal CongestionRunny NoseSneezing
SYMBICORT AEROSPHERE
BUDESONIDE
3 shared
AstraZeneca
Shared indications:
Nasal CongestionRunny NoseSneezing
ALLZITAL
ACETAMINOPHEN
2 shared
PHARMOBEDIENT
Shared indications:
HeadacheFever
ANAPROX DS
NAPROXEN SODIUM
2 shared
ATNAHS PHARMA US
Shared indications:
HeadacheFever
ANEXSIA 5/325
ACETAMINOPHEN
2 shared
SPECGX LLC
Shared indications:
HeadacheFever
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

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 IN 0.9% SODIUM CHLORIDE FDA Label Details

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Indications & Usage

FDA Label (PDF)

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

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