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Benzonatate 200 mg Capsule, 60-count — NDC 62135-0441-60 package photo

Benzonatate 200 mg Capsule, 60-count

by Chartwell RX, LLC · 60 CAPSULE in 1 BOTTLE (62135-441-60)
NDC 62135-0441-60
🏷️ FDA NDC (as labeled) 62135-441-60 billing pads the product segment with a zero
This package
Contains60-count Cost per ea$0.1021 NADAC Per package$6.13 / 60 capsules Pack sizes2 compare ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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

FDA NDC (as labeled) 62135-441-60
Product NDC 62135-441
11-digit billing NDC 62135044160
NCPDP billing unit EA — each (per item)
RxCUI 197397, 283417
UNII 5P4DHS6ENR
UPC 0362135440015, 0362135441319, 0362135440312, 0362135441609 +1 more
Application # ANDA040682
SPL Set ID 8a17033c-1ad3-4c7a-92ee-f55756833986
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 2018-05-01
Route ORAL
Dosage form CAPSULE
Substance BENZONATATE
GPI-14 43102010000110
GCN Seq No 044168
GCN 93007
HICL code 001929
Ingredient (HICL) Benzonatate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6C
Therapeutic class — specific (HIC3) Antitussives, Non-Opioid
AHFS code 48:08.00.00
AHFS class Antitussives
FDB label name BENZONATATE 200 MG CAPSULE
FDB brand name Benzonatate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 62135-441-60 — a 5-3-2 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 product segment → 62135-0441-60. 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.

🏭 Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderHERITAGE PHARMACEUTICALS LABS INC DBA AVET PHARMACEUTICALS LABS INC
FDA applicationANDA040682 (ANDA)
Labeler code62135
First marketedMay 2018
Product typeHuman Prescription Drug
Portfolio521 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.

🩺 Clinical

Label name BENZONATATE 200 MG CAPSULE Ingredient Benzonatate
📖 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
  • It works by numbing tiny nerve sensors in your airways and lungs that trigger the urge to cough. Think of it like a local anesthetic for your respiratory system — it quiets those s...
  • What is benzonatate actually doing to stop my cough?
  • This is genuinely one of the most important rules with benzonatate. If you chew, crush, or suck on the capsule, the medication gets released directly in your mouth and throat. It t...
  • Why does my pharmacist keep saying I must swallow it whole?
📖 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.

💊 What it looks like

Color yellow
ShapeCapsule
ImprintA6
Size16 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 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 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.

5 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 DailyMedingredient 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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.102 $6.13 / 60 capsules
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.124 $0.102
▼ Down 18% over the last 12 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Benzonatate 200 mg 23155-0899-01 Heritage 100 capsules $0.102 AA Availability likely
Benzonatate 200 mg 31722-0958-01 Camber 100 capsules $0.102 AA Availability likely
Benzonatate 200 mg 42806-0715-01 Epic 100 capsules $0.102 AA Availability likely
Benzonatate 200 mgthis 62135-0441-60 Chartwell 60 capsules $0.102 AA Availability likely
Benzonatate 200 mg 64380-0713-06 Strides 100 capsules $0.102 AA Availability likely
Benzonatate 200 mg 64980-0635-01 Rising 100 capsules $0.102 AA Availability likely
Benzonatate 200 mg 67877-0575-01 Ascend 100 capsules $0.102 AA Availability likely
Benzonatate 200 mg 68382-0091-01 Zydus 100 capsules $0.102 AA Availability likely
Benzonatate 200 mg 69452-0144-20 Bionpharma 100 capsules $0.102 AA Availability likely
Benzonatate 200 mg 51224-0001-50 TAGI 100 capsules $0.120 AA FDA listed +18%
Benzonatate 200 mg 25000-0003-03 MARKSANS 30 capsules AA 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 42708-0171-21 QPharma 21 capsules AA FDA listed
Benzonatate 200 mg 49483-0947-01 TIME 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 51655-0776-52 Northwind 30 capsules AA FDA listed
Benzonatate 200 mg 60429-0914-01 Golden 100 capsules AA FDA listed
Benzonatate 200 mg 63187-0606-14 Proficient 14 capsules AA FDA listed
Benzonatate 200 mg 63629-1229-01 Bryant 100 capsules AA 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 65162-0537-10 Amneal 100 capsules AA FDA listed
Benzonatate 200 mg 65841-0843-01 Zydus 100 capsules AA FDA listed
Benzonatate 200 mg 67296-1464-03 RedPharm 30 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 67296-2153-01 Redpharm 15 capsules AA FDA listed
Benzonatate 200 mg 67296-2202-03 Redpharm 30 capsules AA FDA listed
Benzonatate 200 mg 67296-2244-05 Redpharm 15 capsules AA Discontinued
Benzonatate 200 mg 68071-1395-03 NuCare 30 capsules AA FDA listed
Benzonatate 200 mg 68071-2562-03 NuCare 30 capsules AA FDA listed
Benzonatate 200 mg 68094-0901-50 Precision 100 capsules AA FDA listed
Benzonatate 200 mg 68788-8329-01 Preferred 15 capsules AA FDA listed
Benzonatate 200 mg 68788-8336-01 Preferred 15 capsules AA FDA listed
Benzonatate 200 mg 68788-8405-01 Preferred 15 capsules AA FDA listed
Benzonatate 200 mg 70518-2491-00 REMEDYREPACK 30 capsules AA Discontinued
Benzonatate 200 mg 70518-4182-00 REMEDYREPACK 30 capsules AA FDA listed
Benzonatate 200 mg 70518-4497-00 REMEDYREPACK 20 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 71205-0643-10 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 71335-0031-01 Bryant 30 capsules AA FDA listed
benzonatate 200 mg 71335-0725-01 Bryant 30 capsules FDA listed
Benzonatate 200 mg 71335-1553-01 Bryant 30 capsules AA FDA listed
Benzonatate 200 mg 71335-1880-01 Bryant 30 capsules AA FDA listed
Benzonatate 200 mg 71335-2021-01 Bryant 30 capsules AA FDA listed
Benzonatate 200 mg 71335-2486-00 Bryant 6 capsules AA FDA listed
Benzonatate 200 mg 71335-2590-00 Bryant 6 capsules AA FDA listed
Benzonatate 200 mg 71335-2788-01 Bryant 21 capsules AA FDA listed
Benzonatate 200 mg 71335-2790-01 Bryant 21 capsules AA FDA listed
Benzonatate 200 mg 71335-2853-01 Bryant 100 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 72189-0192-20 DIRECT 20 capsules AA FDA listed
Benzonatate 200 mg 72189-0606-20 Direct_rx 20 capsules AA FDA listed
Benzonatate 200 mg 72789-0232-21 PD-Rx 21 capsules AA FDA listed
Benzonatate 200 mg 72865-0119-01 XLCare 100 capsules AA FDA listed
Benzonatate 200 mg 76420-0804-01 Asclemed 100 capsules AA FDA listed
Benzonatate 200 mg 85766-0068-01 Sportpharm 100 capsules AA FDA listed
Benzonatate 200 mg 85766-0090-01 Sportpharm 100 capsules AA FDA listed
Benzonatate 200 mg 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

🏛️
2018
On the market since
May 2018
📍
2026
Currently FDA-listed
8 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.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
62135-0441-31 300 CAPSULE in 1 BOTTLE (62135-441-31) $0.1021 / ea $30.62 2023-01-05 Active
62135-0441-60 You're viewing this 60 CAPSULE in 1 BOTTLE (62135-441-60) $0.1021 / ea $6.12 2023-01-05 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.1021 NADAC).

Pack size FAQ

What quantity is in NDC 62135-0441-60?
NDC 62135-0441-60 is a 60-count package — 60 capsule in 1 bottle.
What is the difference between NDC 62135-0441-60 and NDC 62135-0441-31?
Both are Benzonatate 200 mg Capsule — the drug itself is identical. NDC 62135-0441-60 is the 60-count package, while NDC 62135-0441-31 is the 300 capsules package.
What NDC number is used to bill for this package of Benzonatate 200 mg Capsule?
Bill NDC 62135-0441-60 — the 11-digit billing format is 62135044160. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 12 words

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

⏱️ Dosage and Administration 63 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 130 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 reportedwithin one hour of ingestion.

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

🤒 Adverse Reactions 72 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.

🆘 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 refluxes 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 123 words

HOW SUPPLIED Benzonatate Capsules, USP are available as: 100 mg (oval, yellow) soft gelatin capsules with imprint “A5”. NDC 62135-440-90 Bottles of 90 NDC 62135-440-01 Bottles of 100 NDC 62135-440-31 Bottles of 300 200 mg (oblong, yellow) soft gelatin capsules with imprint “A6”. NDC 62135-441-60 Bottles of 60 NDC 62135-441-31 Bottles of 300 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. To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Swiss Caps AG Kirchberg, Switzerland Manufactured for: Chartwell RX, LLC 77 Brenner Drive Congers, NY 10920 Revised: 03/2023 L71173

📋 Description 53 words

DESCRIPTION Benzonatate, a non-narcotic 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. image description

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