Over-the-counter medicine
Guaifenesin and pseudoephedrine Brand names: Mucinex; first approved as Mucinex D
Guaifenesin and pseudoephedrine (Mucinex) is an over-the-counter medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 28 generic labelers, and pharmacies paid $0.384 per unit (Guaifenesin-pse ER 600-60 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the guaifenesin and pseudoephedrine FDA label on DailyMed (effective May 27, 2026, Reckitt Benckiser LLC); the NDA 21585 record on Drugs@FDA; every guaifenesin and pseudoephedrine label on DailyMed.
Highlights of the record
FDA label of May 27, 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 nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure
Forms and strengths
- 600 mg / 60 mg
- 1200 mg / 120 mg
Extended-release tablet; multilayer extended-release tablet.
On the market
- Earliest approval on file
- June 22, 2004 Mucinex D, Reckitt Benckiser; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first May 27, 2015; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 30 of which 28 under generic applications, 3 under brand applications, repackagers included; 2 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.384 per unit Guaifenesin-pse ER 600-60 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,926 through July 30, 2026
What is guaifenesin and pseudoephedrine 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 nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure
Conditions named in the indications of guaifenesin and pseudoephedrine's FDA labels, with every medicine labeled for each:
From other guaifenesin and pseudoephedrine labelsCough and cold: Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves nasal congestion due to: common cold hay fever upper respiratory …
FDA pharmacologic class: Expectorant and alpha-Adrenergic Agonist.
Source: FDA drug label (Mucinex D), Reckitt Benckiser LLC, effective May 27, 2026 (SPL set d5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f), via openFDA; the full label on DailyMed
Is there a generic for guaifenesin and pseudoephedrine (Mucinex)?
The FDA approved the first generic guaifenesin and pseudoephedrine on May 27, 2015. 6 generic applications are approved; 5 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 guaifenesin and pseudoephedrine from 28 labelers under a generic (ANDA) application and from 3 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
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for guaifenesin and pseudoephedrine (Mucinex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.384 per unit (Guaifenesin-pse ER 600-60 mg), up 23% from $0.312 on October 8, 2025. 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.
- Guaifenesin-pse ER 600-60 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ft mucus relief d ER 1,200-120 | Generic | $0.423 per unit | n/a | n/a |
| Ft mucus relief d ER 600-60 mg | Generic | $0.384 per unit | n/a | +23% |
| Guaifenesin-pse ER 1200-120 mg | Generic | $0.423 per unit | n/a | n/a |
| Guaifenesin-pse ER 600-60 mg | Generic | $0.384 per unit | n/a | +23% |
| Mucus d ER 1,200-120 mg tablet | Generic | $0.423 per tablet | $12.70 | n/a |
| Mucus d ER 600-60 mg tablet | Generic | $0.384 per tablet | $11.52 | n/a |
| Mucus relief d ER 1,200-120 mg | Generic | $0.423 per unit | n/a | n/a |
| Mucus relief d ER 600-60 mg tablet | Generic | $0.384 per tablet | $11.52 | +26% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for guaifenesin and pseudoephedrine?
The FDA Adverse Event Reporting System holds 1,926 reports that list guaifenesin and pseudoephedrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 62 are coded as a death and 220 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 guaifenesin and pseudoephedrine?
12 other medicines are given the same way (oral) and in the same FDA class as guaifenesin and pseudoephedrine 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 | Allergies, 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 |
| Dextromethorphan | Cough and cold | 28 labelers | $0.122 per unit 15 mg softgel | No current entry |
| Phenylephrine | Cough and cold | none listed | $0.0496 per tablet 10 mg tablet | No current entry |
| Dextromethorphan and promethazine | Cough and cold | 13 labelers | $0.039 per mL 6.25-15 mg/5 mL solution | No current entry |
| Homatropine methylbromide and hydrocodone | Cough and cold | 3 labelers | $0.922 per tablet 5-1.5 mg tablet | No current entry |
| Codeine and promethazine | Cough and cold | 5 labelers | $0.0697 per mL Promethazine-codeine solution | No current entry |
| Ibuprofen and phenylephrine | Cough and cold | 3 labelers | n/a | 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
- Guaifenesin and pseudoephedrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other