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Prescription medicine · generic available

Benzonatate

Drug class: Non-narcotic Antitussive

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

Some labelsBoxed warning
None listedFDA shortage list
4Recalls (FDA reports)
40Companies
1993First FDA approval on file

Quick answers

What is Benzonatate used for?
The FDA-approved label (Benzonatate, Major Pharmaceuticals, September 2, 2026) says: “Benzonatate capsules, USP are indicated for the symptomatic relief of cough.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Benzonatate have a boxed warning?
The label we quote has no boxed warning, but 3 of 105 FDA labels for this medicine do. Check the label of your own product.
Is there a shortage of Benzonatate?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Benzonatate been recalled?
FDA enforcement reports list 4 recalls of products of this medicine; the newest started December 26, 2023 (Class III). A recall usually concerns specific lots, not every product.
Who makes Benzonatate?
40 companies list prescription products of Benzonatate in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and A-S Medication Solutions.

What Benzonatate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Benzonatate capsules, USP are indicated for the symptomatic relief of cough.

— FDA label: Benzonatate, Major Pharmaceuticals, effective September 2, 2026. Read the full label on DailyMed →

The FDA has 105 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

3 of 105 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsCapsule · Capsule, liquid filled
RouteOral
Prescription products140 in the FDA NDC Directory

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Benzonatate, by strength and form
Strength and formGeneric or brandPharmacies pay
benzonatate 100 mg
capsule		 Generic $0.0616 per capsule
benzonatate 100 mg
capsule, liquid filled		 Generic $0.0616 per capsule
benzonatate 200 mg
capsule		 Generic $0.1013 per capsule
benzonatate 200 mg
capsule, liquid filled		 Generic $0.1013 per capsule

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (10)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. December 26, 2023 · Class III · Ongoing · D-0257-2024

    Superpotent drug: Assay results were slightly above specification at the time zero point.

    Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11 — Amerisource Health Services LLC

  2. May 9, 2017 · Class III · Terminated · D-0858-2017

    Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.

    Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06 — Strides Pharma INC

  3. January 6, 2015 · Class II · Terminated · D-0430-2015

    Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules

    Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose) — American Health Packaging

  4. December 23, 2014 · Class II · Terminated · D-0325-2015

    Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.

    Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bo — Zydus Pharmaceuticals USA Inc

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)197397, 283417, 903291
SPL set ID of the quoted label324f65ae-09d1-4bd6-9d2b-593035201ecd
FDA labels (SPL)105
FDA applications10 ANDA
Active ingredients (FDA)BENZONATATE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Benzonatate, Major Pharmaceuticals, effective September 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers