TheraRadar
Data updated: May 26, 2026

ADVIL ALLERGY AND CONGESTION RELIEF (chlorpheniramine maleate)

Respiratory Approved 2011-12-21
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
14
Years on Market

Details

Status
Over-the-counter
First Approved
2011-12-21
Routes
ORAL
Dosage Forms
TABLET

Companies

HALEON US HOLDINGS
Active Ingredient: CHLORPHENIRAMINE MALEATE , IBUPROFEN , PHENYLEPHRINE HYDROCHLORIDE

ADVIL ALLERGY AND CONGESTION RELIEF Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2011 to 2021 · 1 indication expansions
Nov 2021 SUPPL
Label · Labeling
FDA Letter Label
Sep 2019 SUPPL
Label · Labeling
FDA Letter Label
Jul 2019 SUPPL
Label · Labeling
FDA Letter Label

What ADVIL ALLERGY AND CONGESTION RELIEF Treats

2 FDA approvals

Originally approved for its first indication in 2011 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT01938144 B3971002 U1111-1147-8736 Ph 3 withdrawn Evaluation of the Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

ADVIL ALLERGY AND CONGESTION RELIEF FDA Label Details

Track ADVIL ALLERGY AND CONGESTION RELIEF with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA022113 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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