Over-the-counter medicine

Dextromethorphan and guaifenesin and naproxen Brand names: Mucinex; first approved as Mucinex 12Hr Cold & Fever Multi-Symptom

Dextromethorphan and guaifenesin and naproxen (Mucinex) is an over-the-counter medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.

No generic listed
Over the counter

Check it at the source: the dextromethorphan and guaifenesin and naproxen FDA label on DailyMed (effective June 2, 2026, Reckitt Benckiser LLC); the NDA 217338 record on Drugs@FDA; every dextromethorphan and guaifenesin and naproxen label on DailyMed.

Highlights of the record

FDA label of June 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep ■ minor aches and pains due to headache and the common cold ■ tempo

Forms and strengths

30 mg / 110 mg / 600 mg

Extended-release tablet.

On the market

Earliest approval on file: December 22, 2025 Mucinex 12Hr Cold & Fever Multi-Symptom, Reckitt Benckiser; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: October 11, 2036 Mucinex 12Hr Cold & Fever Multi-Symptom tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 20,453 through July 30, 2026

What is dextromethorphan and guaifenesin and naproxen used for?

From the label: indications and usage
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep ■ minor aches and pains due to headache and the common cold ■ temporarily reduces fever

Conditions named in the indications of dextromethorphan and guaifenesin and naproxen's FDA labels, with every medicine labeled for each:

Fever

FDA pharmacologic class: Expectorant, Nonsteroidal Anti-inflammatory Drug, Sigma-1 Agonist and Uncompetitive N-methyl-D-aspartate Receptor Antagonist.

Source: FDA drug label (Mucinex 12HR Cold and Fever Multi-Symptom), Reckitt Benckiser LLC, effective June 2, 2026 (SPL set 49f1f415-8017-0974-e063-6294a90a8918), via openFDA; the full label on DailyMed

Is there a generic for dextromethorphan and guaifenesin and naproxen (Mucinex)?

No generic dextromethorphan and guaifenesin and naproxen is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 3 patents for Mucinex 12Hr Cold & Fever Multi-Symptom tablets, the last expiring on October 11, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2025 earliest approval on file
2036 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the dextromethorphan and guaifenesin and naproxen label say about other medicines?

The dextromethorphan and guaifenesin and naproxen label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Aspirin	warnings	Warnings Allergy Alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin.

Check dextromethorphan and guaifenesin and naproxen against other medicines

What do FAERS reports show for dextromethorphan and guaifenesin and naproxen?

The FDA Adverse Event Reporting System holds 20,453 reports that list dextromethorphan and guaifenesin and naproxen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,259 are coded as a death and 4,886 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)1,751
Dyspnoea1,651
Fatigue1,370
Nausea1,271
Cough (a use or a product term, not a reaction)1,238
Diarrhoea1,234
Pneumonia1,175
Headache (a use or a product term, not a reaction)1,127

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as dextromethorphan and guaifenesin and naproxen?

4 other medicines are given the same way (oral) and in the same FDA class as dextromethorphan and guaifenesin and naproxen or labeled mainly for the same use (fever), the same class first. Fever lists all 8 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Ibuprofen	Fever	273 labelers	$0.0573 per tablet 800 mg tablet	No current entry
Acetaminophen and aspirin and caffeine	Fever	39 labelers	$0.0648 per unit 250-250-65 mg cplt	No current entry
Acetaminophen	Fever	79 labelers	$0.0339 per unit 500 mg caplet	No current entry
Meclofenamate	Fever	1 labeler	n/a	No current entry

Every medicine labeled for the same conditions as dextromethorphan and guaifenesin and naproxen

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to dextromethorphan and guaifenesin and naproxen: 4 medicines for the same use
Other expectorants: the pharmacologic class, with prices and generics
Dextromethorphan and guaifenesin and naproxen side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other