Prescription and over-the-counter medicine
Guaifenesin Brand names: Mucinex, Mucus
Guaifenesin (Mucinex) is a prescription and over-the-counter medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 91 generic labelers, and pharmacies paid $0.284 per ft mucus relief ER 600 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the guaifenesin FDA label on DailyMed (effective May 27, 2026, Reckitt Benckiser LLC); the NDA 21282 record on Drugs@FDA; every guaifenesin 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
Forms and strengths
- 600 mg
- 1200 mg
Extended-release tablet; multilayer extended-release tablet; tablet.
On the market
- Earliest approval on file
- July 12, 2002 Mucinex, Reckitt Benckiser; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first November 23, 2011; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 95 of which 91 under generic applications, 8 under brand applications, repackagers included; 61 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.284 per tablet Ft mucus relief ER 600 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2013 0 Class I among all firms' recalls; latest January 14, 2014; 2 more by firms not listed as its makers
- FAERS reports
- 30,329 through July 30, 2026
What is 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
Conditions named in the indications of guaifenesin's FDA labels, with every medicine labeled for each:
From other guaifenesin labelsCough and cold: Uses temporarily relieves cough due to minor thraot and bronchial irritations as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
FDA pharmacologic class: Expectorant.
Source: FDA drug label (Mucinex Maximum Strength), Reckitt Benckiser LLC, effective May 27, 2026 (SPL set 47f5323c-ee3a-400d-b133-31d9c286fafd), via openFDA; the full label on DailyMed
Is there a generic for guaifenesin (Mucinex)?
The FDA approved the first generic guaifenesin on November 23, 2011. 9 generic applications are approved; 9 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 from 91 labelers under a generic (ANDA) application and from 8 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2002 earliest approval on file
- 2011 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 guaifenesin (Mucinex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.284 per Ft mucus relief ER 600 mg tablet, down 11% from $0.319 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 mucus relief ER 600 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Chest congest rlf 400 mg tablet | Generic | $0.0656 per tablet | $1.97 | -4% |
| Chest congestion relief solution | Generic | $0.011 per mL | n/a | -14% |
| Ft adult tussin 200 mg/10 mL | Generic | $0.0206 per mL | n/a | +3% |
| Ft chest congest 400 mg caplet | Generic | $0.0656 per unit | n/a | -4% |
| Ft mucus relief ER 1,200 mg tablet | Generic | $0.432 per tablet | $12.95 | -6% |
| Ft mucus relief ER 600 mg tablet | Generic | $0.284 per tablet | $8.52 | -11% |
| Gnp mucus ER 1,200 mg tablet | Generic | $0.432 per tablet | $12.95 | -6% |
| Gnp mucus ER 600 mg tablet | Generic | $0.284 per tablet | $8.52 | -11% |
| Gnp mucus relief 400 mg tablet | Generic | $0.0656 per tablet | $1.97 | -4% |
| Gnp tussin mucus-con 200 mg/10 | Generic | $0.0206 per mL | n/a | +3% |
| Gs mucus ER 1,200 mg tablet | Generic | $0.432 per tablet | $12.95 | -6% |
| Gs mucus ER 600 mg caplet | Generic | $0.284 per unit | n/a | -11% |
| Gs mucus ER 600 mg tablet | Generic | $0.284 per tablet | $8.52 | -11% |
| Guaifenesin 100 mg/5 mL solution | Generic | $0.011 per mL | n/a | -14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has guaifenesin been recalled?
The FDA's Enforcement Report lists 8 recalls naming guaifenesin since 2013: 0 Class I (the most serious), 8 Class II, 0 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of 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 |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| August 24, 2021 | Class II | Efficient Laboratories, Inc. not a listed maker | Microbial Contamination of Non-Sterile Products |
| January 14, 2014 | Class II | Traxx International Corp | Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; GUAIFENESIN, Tablet, 200 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401 … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: AD21790_52, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling:Label Mixup; guaiFENesin ER Tablet, 600 mg may be potentially mislabeled as OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for guaifenesin?
The FDA Adverse Event Reporting System holds 30,329 reports that list guaifenesin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,205 are coded as a death and 7,847 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?
16 other medicines are given the same way (oral) and in the same FDA class as 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 |
| Dextromethorphan | Cough and cold | 28 labelers | $0.122 per unit 15 mg softgel | 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 |
| Dextromethorphan and promethazine | Cough and cold | 13 labelers | $0.039 per mL 6.25-15 mg/5 mL solution | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does guaifenesin compare with medicines for the same use?
5 side-by-side pages set guaifenesin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other expectorants
- the pharmacologic class, with prices and generics
- Guaifenesin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other