What is IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE used for?

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE is an FDA-approved medication. See full prescribing information for approved uses.

Is IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE FDA approved?

Yes, IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE is FDA approved (first approved 2014-07-03) and manufactured by PERRIGO R AND D.

Who makes IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE?

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE is manufactured by PERRIGO R AND D.

Data updated: Mar 10, 2026

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

IBUPROFEN

Approved 2014-07-03

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Indication

Phase 3 Trials

Years on Market

Details

Status: Over-the-counter
First Approved: 2014-07-03
Routes: ORAL
Dosage Forms: TABLET

Companies

PERRIGO R AND D

Active Ingredient: IBUPROFEN , PHENYLEPHRINE HYDROCHLORIDE

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE Approval History

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What IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

Other (1)

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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

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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.

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE FDA Label Details

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Data Sources

FDA Approval: ANDA203200 → Trials: ClinicalTrials.gov →

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