Prescription medicine
Benzonatate First approved as Tessalon
Benzonatate (Tessalon) is a prescription medicine with an FDA approval on record since 1958. FDA's NDC Directory lists it from 45 generic labelers, and pharmacies paid $0.0656 per benzonatate 100 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the benzonatate FDA label on DailyMed (effective August 3, 2026, Epic Pharma LLC); the NDA 11210 record on Drugs@FDA; every benzonatate label on DailyMed.
Highlights of the record
FDA label of August 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBenzonatate capsules, USP are indicated for the symptomatic relief of cough.
Forms and strengths
- 100 mg
- 150 mg
- 200 mg
Capsule; liquid-filled capsule.
On the market
- Earliest approval on file
- February 10, 1958 Tessalon, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first January 29, 1993; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 45 of which 45 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0656 per capsule Benzonatate 100 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 7 since 2014 1 Class I among all firms' recalls; latest December 26, 2023
- FAERS reports
- 16,446 through July 30, 2026
What is benzonatate used for?
From the label: indications and usageBenzonatate capsules, USP are indicated for the symptomatic relief of cough.
Conditions named in the indications of benzonatate's FDA labels, with every medicine labeled for each:
From other benzonatate labelsCough and cold: INDICATIONS AND USAGE Benzonatate capsules, USP are indicated for the symptomatic relief of cough.
FDA pharmacologic class: Non-narcotic Antitussive.
Source: FDA drug label (Benzonatate), Epic Pharma LLC, effective August 3, 2026 (SPL set 9b35e9d5-7d72-4f51-a245-ad2467ab40e9), via openFDA; the full label on DailyMed
Is there a generic for benzonatate (Tessalon)?
The FDA approved the first generic benzonatate on January 29, 1993. 16 generic applications are approved; 11 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 benzonatate from 45 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1958 earliest approval on file
- 1993 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 benzonatate (Tessalon)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0656 per Benzonatate 100 mg capsule, down 8% from $0.0713 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.
- Benzonatate 100 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Benzonatate 100 mg capsule | Generic | $0.0656 per capsule | $1.97 | -8% |
| Benzonatate 200 mg capsule | Generic | $0.101 per capsule | $3.04 | -5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has benzonatate been recalled?
The FDA's Enforcement Report lists 7 recalls naming benzonatate since 2014: 1 Class I (the most serious), 3 Class II, 3 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 26, 2023 | Class III | Amerisource Health Services LLC | Superpotent drug: Assay results were slightly above specification at the time zero point. |
| January 15, 2021 | Class I | Calvin Scott & Company, Inc. | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets … |
| May 9, 2017 | Class III | Strides Pharma INC | Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content. |
| January 6, 2015 | Class II | American Health Packaging | Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules |
| December 23, 2014 | Class II | Zydus Pharmaceuticals USA Inc | Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. |
| November 26, 2014 | Class II | Zydus Pharmaceuticals USA Inc | Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. |
| September 24, 2014 | Class III | Zydus Pharmaceuticals USA Inc | Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for benzonatate?
The FDA Adverse Event Reporting System holds 16,446 reports that list benzonatate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,952 are coded as a death and 5,621 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 benzonatate?
18 other medicines are given the same way (oral) and in the same FDA class as benzonatate 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 |
| Dextromethorphan and guaifenesin | Cough and cold | 61 labelers | $0.0207 per mL 200-20 mg/20 mL | No current entry |
| Guaifenesin | Cough and cold | 102 labelers | $0.284 per tablet 600 mg tablet | 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 |
| Guaifenesin and pseudoephedrine | Cough and cold | 30 labelers | $0.384 per unit 600-60 mg | 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does benzonatate compare with medicines for the same use?
3 side-by-side pages set benzonatate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Benzonatate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other