Over-the-counter medicine
Dextromethorphan and guaifenesin Brand names: Mucinex; first approved as Mucinex Dm
Dextromethorphan and guaifenesin (Mucinex) is an over-the-counter medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 58 generic labelers, and pharmacies paid $0.0207 per mL (Ft tussin dm 200-20 mg/20 mL) in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the dextromethorphan and guaifenesin FDA label on DailyMed (effective June 15, 2026, Reckitt Benckiser LLC); the NDA 21620 record on Drugs@FDA; every dextromethorphan and guaifenesin label on DailyMed.
Highlights of the record
FDA label of June 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagehelps 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
Forms and strengths
- 30 mg / 600 mg
- 60 mg / 1200 mg
- 600 mg / 30 mg
- 1200 mg / 60 mg
Extended-release tablet; tablet.
On the market
- Earliest approval on file
- April 29, 2004 Mucinex Dm, Reckitt Benckiser; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first August 31, 2015; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 62 of which 58 under generic applications, 6 under brand applications, repackagers included; 121 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.0207 per mL Ft tussin dm 200-20 mg/20 mL
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2014 0 Class I among all firms' recalls; latest November 10, 2014; 5 more by firms not listed as its makers
- FAERS reports
- 8,415 through July 30, 2026
What is dextromethorphan and guaifenesin used for?
From the label: indications and usagehelps 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
Conditions named in the indications of dextromethorphan and guaifenesin's FDA labels, with every medicine labeled for each:
From other dextromethorphan and guaifenesin labelsCough and cold: Uses helps loosen phlegm (mucus) and thin bronchial secretions to 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 …
FDA pharmacologic class: Expectorant, Sigma-1 Agonist and Uncompetitive N-methyl-D-aspartate Receptor Antagonist.
Source: FDA drug label (Mucinex DM), Reckitt Benckiser LLC, effective June 15, 2026 (SPL set 70987d06-d206-445f-bd0d-5e1345b8465c), via openFDA; the full label on DailyMed
Is there a generic for dextromethorphan and guaifenesin (Mucinex)?
The FDA approved the first generic dextromethorphan and guaifenesin on August 31, 2015. 6 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dextromethorphan and guaifenesin from 58 labelers under a generic (ANDA) application and from 6 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2015 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dextromethorphan and guaifenesin (Mucinex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0207 per mL (Ft tussin dm 200-20 mg/20 mL), up 18% from $0.0175 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ft tussin dm 200-20 mg/20 mL (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Chest cong rlf dm 400-20 mg tablet | Generic | $0.0819 per tablet | $2.46 | +4% |
| Chest congestion relief dm syringe | Generic | $0.0091 per mL | n/a | +17% |
| Chest congst-cough relief tablet | Generic | $0.0819 per tablet | $2.46 | +4% |
| Cough dm 20-200 mg/20 mL syrup | Generic | $0.0168 per mL | n/a | -2% |
| Ft chest cong rlf dm 400-20 mg | Generic | $0.0819 per unit | n/a | +4% |
| Ft mucus dm ER 600-30 mg tablet | Generic | $0.356 per tablet | $10.68 | -13% |
| Ft mucus dm max ER 1200-60 mg | Generic | $0.545 per unit | n/a | -0.9% |
| Ft tussin dm 200-20 mg/20 mL | Generic | $0.0207 per mL | n/a | +18% |
| Ft tussin dm 400-20 mg/20 mL | Generic | $0.0235 per mL | n/a | +8% |
| Gnp child cgh rlf 5-100 mg/5 mL | Generic | $0.0235 per mL | n/a | +8% |
| Gnp mucus dm ER 600-30 mg tablet | Generic | $0.356 per tablet | $10.68 | n/a |
| Gnp mucus dm max ER 1200-60 mg | Generic | $0.545 per unit | n/a | -0.9% |
| Gnp mucus rlf dm 20-400 mg tablet | Generic | $0.0819 per tablet | $2.46 | +4% |
| Gnp tussin dm 200-20 mg/20 mL | Generic | $0.0148 per mL | n/a | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dextromethorphan and guaifenesin been recalled?
The FDA's Enforcement Report lists 6 recalls naming dextromethorphan and guaifenesin since 2014: 0 Class I (the most serious), 3 Class II, 3 Class III; 2 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of dextromethorphan and guaifenesin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 25, 2024 | Class III | Denison Pharmaceuticals, LLC not a listed maker | Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. |
| June 16, 2020 | Class II | Glaxosmithkline Consumer Healthcare Holdings not a listed maker | Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. |
| June 21, 2019 | Class II | Pharma-Natural Inc. not a listed maker | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing … |
| April 15, 2015 | Class II | Reckitt Benckiser LLC not a listed maker | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts … |
| November 10, 2014 | Class III | Reckitt Benckiser LLC | Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for dextromethorphan and guaifenesin?
The FDA Adverse Event Reporting System holds 8,415 reports that list dextromethorphan and guaifenesin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 176 are coded as a death and 874 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
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?
14 other medicines are given the same way (oral) and in the same FDA class as dextromethorphan and guaifenesin or labeled mainly for the same use (cough and cold), the same class first. Cough and cold lists all 31 medicines labeled for it, by any route. The first 8 are below. 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 |
|---|---|---|---|---|
| Diphenhydramine | Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Benzonatate | Cough and cold | 45 labelers | $0.0656 per capsule 100 mg capsule | No current entry |
| Pseudoephedrine | Cough and cold | 34 labelers | $0.281 per tablet 120 mg tablet | No current entry |
| Phenylephrine | Cough and cold | none listed | $0.0496 per tablet 10 mg tablet | No current entry |
| Loratadine and pseudoephedrine | Cough and cold | 31 labelers | $0.553 per tablet Allergy relief-nasal decong tablet | No current entry |
| Fexofenadine and pseudoephedrine | Cough and cold | 27 labelers | $0.483 per tablet 60-120 tablet | No current entry |
| Ibuprofen and pseudoephedrine | Cough and cold | 9 labelers | n/a | No current entry |
| Naproxen and pseudoephedrine | Cough and cold | 10 labelers | $0.244 per unit 220-120 mg | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other expectorants
- the pharmacologic class, with prices and generics
- Dextromethorphan and guaifenesin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other