TheraRadar
Data updated: Nov 8, 2026

MUCINEX (guaifenesin) · RECKITT BENCKISER

Trial Activity: Declining
Respiratory Approved 2002-07-12
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Reckitt Benckiser LLC conducting 4 trials (80%)
3 indications explored (Focused)
→ healthy subjects (3 trials)
→ acute respiratory infection (1 trials)
→ acute upper respiratory tract infection (1 trials)
1
Indication
--
Phase 3 Trials
24
Years on Market

Details

Status
Over-the-counter
First Approved
2002-07-12
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

RECKITT BENCKISER
Active Ingredient: GUAIFENESIN

MUCINEX Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
38 FDA actions from 2002 to 2024
Aug 2024 SUPPL
Label · Labeling
FDA Letter Label
Feb 2021 SUPPL
Label · Labeling
FDA Letter Label
Apr 2020 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter

What MUCINEX Treats

1 FDA approvals

Originally approved for its first indication in 2002 .

  • Other (1)
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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT01202279 Wait and See results posted 2009-MUCD-001 Ph 4 completed Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
NCT01364467 results posted HM13538 Ph 2 completed The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
NCT01114581 MCC/CC results posted 2010-MUC-01 Ph 2 completed Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection
NCT01537081 results posted 2011-MUC-04 Ph 2, Ph 3 completed Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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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.

MUCINEX FDA Label Details

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Data Sources

FDA Approval: NDA021282 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment