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Benzonatate 200 mg Capsule, Liquid Filled, 21-count — NDC 71335-3169-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Benzonatate 200 mg Capsule, Liquid Filled, 21-count — NDC 71335-3169-1 (Billing 71335-3169-01)

by Bryant Ranch Prepack · 21 CAPSULE, LIQUID FILLED in 1 BOTTLE

This is a package of 21 capsules of Benzonatate 200 mg Capsule, Liquid Filled from Bryant Ranch Prepack, marketed since Sep 2024 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 71335-3169-01
🏷️ FDA NDC (as labeled) 71335-3169-1 billing pads the package segment with a zero
This package
Contains21-count Pack sizes4 compare ↓
Main listing for product 71335-3169 · Also comes in: 10 capsules 71335-3169-4 100 capsules 71335-3169-2 500 capsules 71335-3169-3
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Benzonatate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Dec 26, 2023 — Superpotent drug: Assay results were slightly above specification at the time zero point. (Amerisource Health Services LLC) · FDA recall D-0257-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71335-3169-1
Product NDC 71335-3169
11-digit billing NDC 71335316901
RxCUI 283417
UNII 5P4DHS6ENR
Application # ANDA040682
SPL Set ID 0151d970-fd80-482d-ad92-03015eef2618
Established class (EPC) Non-narcotic Antitussive
Physiologic effect Decreased Tracheobronchial Stretch Receptor Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-29
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance BENZONATATE
TE code (Orange Book) AA · RLD · RS
Quick answers
  • RxCUI (RxNorm): 283417
Why two NDCs? The FDA registers this code as 71335-3169-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71335-3169-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Non-narcotic Antitussive class.

Pharmacologic class Non-narcotic Antitussive
Drug family (ATC) Other cough suppressants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Benzonatate is used to relieve cough. Benzonatate is in a class of medications called antitussives (cough suppressants). It works by reducing the cough reflex in the lungs and air passages.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • No, benzonatate is not related to codeine or narcotic cough medicines. Instead of working on your brain, it acts more like a local anesthetic inside your airways — it numbs the ner...
  • What exactly does benzonatate do — is it like cough syrup with codeine?
  • This is one of the most important things to know about benzonatate. The medicine inside acts like a numbing agent — if the capsule breaks open in your mouth, it can rapidly numb yo...
  • Why does my pharmacist keep telling me not to chew the capsule?
📖 Read our full Benzonatate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 capsules 100 capsules 500 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71335-3169-01 You're viewing this Main listing 21 CAPSULE, LIQUID FILLED in 1 BOTTLE 2026-08-11 — Active
71335-3169-02 71335-3169-2 100 CAPSULE, LIQUID FILLED in 1 BOTTLE 2026-08-11 — Active
71335-3169-03 71335-3169-3 500 CAPSULE, LIQUID FILLED in 1 BOTTLE 2026-08-11 — Active
71335-3169-04 71335-3169-4 10 CAPSULE, LIQUID FILLED in 1 BOTTLE 2026-08-11 — Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 21-count package — 21 capsule, liquid filled in 1 bottle.
How does this package differ from NDC 71335-3169-04?
Both are Benzonatate 200 mg Capsule, Liquid Filled — the drug itself is identical. This page's package is the 21-count one, while NDC 71335-3169-04 is the 10 capsules package.
What NDC number is used to bill for this package of Benzonatate 200 mg Capsule, Liquid Filled?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Benzonatate 200 mg 62135-0441-31 Chartwell 300 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 68382-0091-01 Zydus 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 69452-0144-20 Bionpharma 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 23155-0899-01 Heritage 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 67877-0575-01 Ascend 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 64380-0713-06 Strides 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 31722-0958-01 Camber 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 64980-0635-01 Rising 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 42806-0715-01 Epic 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 49483-0947-01 TIME 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 51224-0001-50 TAGI 100 capsules $0.120 AA FDA listed —
Benzonatate 200 mg 63187-0606-14 Proficient 14 capsules — AA FDA listed —
benzonatate 200 mg 71205-0037-10 Proficient 10 capsules — — FDA listed —
Benzonatate 200 mg 71205-0605-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 200 mg 71205-0673-06 Proficient 6 capsules — AA FDA listed —
Benzonatate 200 mg 71205-0887-00 Proficient 100 capsules — AA FDA listed —
benzonatate 200 mg 71205-0972-00 Proficient 100 capsules — — FDA listed —
Benzonatate 200 mg 63629-2475-01 Bryant 500 capsules — AA FDA listed —
Benzonatate 200 mg 63629-2476-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 71335-0031-01 Bryant 30 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2021-01 Bryant 30 capsules — AA FDA listed —
Benzonatate 200 mg 72162-1316-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 72162-1560-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 68071-1395-03 NuCare 30 capsules — AA FDA listed —
Benzonatate 200 mg 70518-4182-00 REMEDYREPACK 30 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2853-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 60429-0914-01 Golden 100 capsules — AA FDA listed —
Benzonatate 200 mg 68094-0901-50 Precision 100 capsules — AA FDA listed —
Benzonatate 200 mg 70518-4497-00 REMEDYREPACK 20 capsules — AA FDA listed —
Benzonatate 200 mg 85766-0090-01 Sportpharm 100 capsules — AA FDA listed —
Benzonatate 200 mg 63629-1229-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 72189-0606-20 Direct_rx 20 capsules — AA FDA listed —
Benzonatate 200 mg 68788-8329-01 Preferred 15 capsules — AA FDA listed —
Benzonatate 200 mg 68788-8405-01 Preferred 15 capsules — AA FDA listed —
Benzonatate 200 mg 71335-1553-01 Bryant 30 capsules — AA FDA listed —
Benzonatate 200 mg 76420-0804-01 Asclemed 100 capsules — AA FDA listed —
Benzonatate 200 mg 67296-2202-03 Redpharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 71335-1880-01 Bryant 30 capsules — AA FDA listed —
Benzonatate 200 mg 42708-0171-21 QPharma 21 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2590-00 Bryant 6 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2790-01 Bryant 21 capsules — AA FDA listed —
Benzonatate 200 mg 72789-0232-21 PD-Rx 21 capsules — AA FDA listed —
Benzonatate 200 mg 51655-0776-52 Northwind 30 capsules — AA FDA listed —
Benzonatate 200 mg 65162-0537-10 Amneal 100 capsules — AA FDA listed —
Benzonatate 200 mg 67296-1464-03 RedPharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 67296-2153-01 Redpharm 15 capsules — AA FDA listed —
Benzonatate 200 mg 68071-2562-03 NuCare 30 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2486-00 Bryant 6 capsules — AA FDA listed —
Benzonatate 200 mg 72865-0119-01 XLCare 100 capsules — AA FDA listed —
Benzonatate 200 mg 67296-1751-03 RedPharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 67296-1833-03 Redpharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 71205-0643-10 Proficient 10 capsules — AA FDA listed —
benzonatate 200 mg 71335-0725-01 Bryant 30 capsules — — FDA listed —
Benzonatate 200 mg 42291-0092-01 AvKARE 100 capsules — AA FDA listed —
Benzonatate 200 mg 42708-0082-21 QPharma, 21 capsules — AA FDA listed —
Benzonatate 200 mg 70518-2491-00 REMEDYREPACK 30 capsules — AA Discontinued —
Benzonatate 200 mg 71335-2788-01 Bryant 21 capsules — AA FDA listed —
Benzonatate 200 mg 72189-0192-20 DIRECT 20 capsules — AA FDA listed —
Benzonatate 200 mg 85766-0068-01 Sportpharm 100 capsules — AA FDA listed —
Benzonatate 200 mg 50090-6080-00 A-S 30 capsules — AA FDA listed —
Benzonatate 200 mg 50090-6294-00 A-S 30 capsules — AA FDA listed —
Benzonatate 200 mg 51655-0762-20 Northwind 20 capsules — AA FDA listed —
Benzonatate 200 mg 65841-0843-01 Zydus 100 capsules — AA FDA listed —
Benzonatate 200 mg 67296-2244-05 Redpharm 15 capsules — AA Discontinued —
Benzonatate 200 mg 68788-8336-01 Preferred 15 capsules — AA FDA listed —
Benzonatate 200 mgthis 71335-3169-01 Bryant 21 capsules — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color yellow
ShapeOval
Imprint200
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII CR6K9C2NHK
    A synthetic preservative derived from methylparaben. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 625NNB0G9N
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps keep the product safe and stable throughout its shelf life.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

12 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderHERITAGE PHARMACEUTICALS LABS INC DBA AVET PHARMACEUTICALS LABS INC
FDA applicationANDA040682 (ANDA)
Labeler code71335
First marketedSep 2024
Product typeHuman Prescription Drug
Portfolio4,436 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

INDICATIONS AND USAGE Benzonatate is indicated for the symptomatic relief of cough.

⏱️ Dosage and Administration 64 words ▾

DOSAGE AND ADMINISTRATION 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 should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

⛔ Contraindications 7 words ▾

CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds.

⚠️ Warnings 131 words ▾

WARNINGS 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 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 to 20 minutes and death has been reported within one hour of ingestion.

If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).

🤒 Adverse Reactions 90 words ▾

ADVERSE REACTIONS 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.

To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 209 words ▾

OVERDOSAGE Intentional and unintentional overdose may result in death, particularly in children. The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.

Signs and Symptoms: The signs and symptoms of overdose of benzonatate have been reported within 15 to 20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise. CNS stimulation may cause restlessness and tremors, which may proceed to clonic convulsions followed by profound CNS depression.

Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion. Treatment: In case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry.

Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage.

Do not use CNS stimulants.

🧬 Clinical Pharmacology 61 words ▾

CLINICAL PHARMACOLOGY Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate has no inhibitory effect on the respiratory center in recommended dosage.

📦 How Supplied / Storage and Handling 90 words ▾

HOW SUPPLIED Benzonatate Capsules, USP are available as: 200 mg Oblong Shape, imprint “200” with white ink, transparent yellow soft gelatin capsules. NDC 71335-3169-1: 21 CAPSULEs in a BOTTLE NDC 71335-3169-2: 100 CAPSULEs in a BOTTLE NDC 71335-3169-3: 500 CAPSULEs in a BOTTLE NDC 71335-3169-4: 10 CAPSULEs in a BOTTLE Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.

Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 83 words ▾

DESCRIPTION Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Benzonatate Capsules, USP contain 100 mg or 200 mg of benzonatate, USP. Benzonatate Capsules also contain: D&C Yellow No.

10, gelatin, glycerin, methylparaben sodium and propylparaben sodium. The white imprinting ink contains the following inactive ingredients: ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze, simethicone and titanium dioxide. FDA approved dissolution test specifications differ from USP.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g., procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication. Information for Patients: Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush benzonatate capsules.

Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.

Keep benzonatate out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15 to 20 minutes and death has been reported within one hour of ingestion.

Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately. Overdosage resulting in death may occur in adults.

Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate at one time.

Usage in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with benzonatate. It is also not known whether benzonatate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Benzonatate should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzonatate is administered to a nursing woman.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate. Pediatric Use: Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10.

Keep out of reach of children.

📄 Package Label / Principal Display Panel 4 words ▾

Benzonatate 200mg Capsules Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Benzonatate — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Benzonatate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$654.6K
Claims incl. refills
49.4K
Beneficiaries
42.4K
Spend / beneficiary
$15.42
Spend / claim
$13.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 10 capsules (71335-3169-04), 100 capsules (71335-3169-02), 500 capsules (71335-3169-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.