Uses
Benzonatate capsules are indicated for the symptomatic relief of cough.
Source: US FDA prescribing information
Molecule
Benzonatate
Non-narcotic Antitussive
Available on request
- Presentations
- 3
- Brands
- 0
- Manufacturers
- 0
- Available from stock
- 0
Benzonatate is a non-narcotic antitussive indicated for the symptomatic relief of cough. It is available as capsules for oral use. MedsAcross supplies Benzonatate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Non-narcotic Antitussive, Decreased Tracheobronchial Stretch Receptor Activity
- ATC classification
- R05DB01 Benzonatate · Cough and cold medicines, subgroup R05D, subgroup R05DB
- US FDA first approval
- 10 February 1958
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Capsule
- Identifiers
- UNII 5P4DHS6ENRRxCUI 18993CAS 104-31-4DrugBank DB00868Q2070778
Clinical information
From the regulator-approved product information. Each section names its source.
Dosing overview
Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
Source: US FDA prescribing information
Contraindications
Hypersensitivity to benzonatate or related compounds.
Source: US FDA prescribing information
Warnings and precautions
Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Psychiatric Effects Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate in combination with other prescribed drugs. Accidental Ingestion and Death in Children Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion.
Source: US FDA prescribing information
Side effects
Potential Adverse Reactions to benzonatate may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule. CNS: sedation, headache, dizziness, mental confusion, visual hallucinations. GI: constipation, nausea, GI upset. Dermatologic: pruritus, skin eruptions. Other: nasal congestion, sensation of burning in the eyes, vague “chilly” sensation, numbness of the chest, hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children.
Source: US FDA prescribing information
Storage
Store at 20° to 25°C (68° to 77°F). Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
3 presentations of Benzonatate, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Benzonatate 100 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Benzonatate 200 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Benzonatate 150 mg capsuleOralGeneric name | — | US FDA | Available on request |
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 10 February 1958 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Benzonatate in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Benzonatate available for export from India?
Yes, on request. MedsAcross lists 3 presentations of Benzonatate and sources them for licensed hospitals, importers and physicians against valid import documents.
Is Benzonatate approved by the US FDA?
Yes. The US FDA first approved Benzonatate on 10 February 1958, according to Drugs@FDA.
Does Benzonatate need cold chain shipping?
No listed presentation of Benzonatate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Benzonatate in?
Benzonatate is classified under ATC code R05DB01 (Benzonatate).
References
- Benzonatate 100 mg prescribing information (Time Cap Laboratories). U.S. National Library of Medicine, DailyMed. Retrieved 7 September 2026
Request Benzonatate for export supply
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