What this pack is
TESSALON is the brand name in this record; benzonatate is the generic name. Read both together with the dosage form (oral capsule).
PACK CHECK · MARKET FIRST
TESSALONGeneric namebenzonatate
How this medicine works
The historical FDA brand label describes peripheral anaesthesia of stretch receptors in the respiratory passages, lungs and pleura, dampening the cough reflex. This mechanism explains the antitussive pathway only; it cannot determine whether a cough is due to infection, asthma, a cardiac problem, a medicine or another cause.
Read source: United States ↗reviewed 2026-08-31More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- TESSALON
- Generic name
- benzonatate
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
6 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. generic label revised June 2026
100 mg benzonatate per capsule; 100-capsule bottle; mg is strength per capsule, not an individual's capsule count or frequency
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-712-06
- Form and route
- Benzonatate 100 mg oral liquid-filled capsule · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-31; actual marketing, stock and availability are not established.
- benzonatate
- 100 mglabelled amount per capsule; must not generate individual use from this figure
- Package
- 100 capsules per bottle
United States label · Current U.S. generic label revised June 2026
100 mg benzonatate per capsule; 500-capsule bottle; mg is strength per capsule, not an individual's capsule count or frequency
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-712-07
- Form and route
- Benzonatate 100 mg oral liquid-filled capsule · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-31; actual marketing, stock and availability are not established.
- benzonatate
- 100 mglabelled amount per capsule; must not generate individual use from this figure
- Package
- 500 capsules per bottle
United States label · Current U.S. generic label revised June 2026
200 mg benzonatate per capsule; 100-capsule bottle; mg is strength per capsule, not an individual's capsule count or frequency
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-713-06
- Form and route
- Benzonatate 200 mg oral liquid-filled capsule · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-31; actual marketing, stock and availability are not established.
- benzonatate
- 200 mglabelled amount per capsule; must not generate individual use from this figure
- Package
- 100 capsules per bottle
United States label · Current U.S. generic label revised June 2026
200 mg benzonatate per capsule; 500-capsule bottle; mg is strength per capsule, not an individual's capsule count or frequency
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 64380-713-07
- Form and route
- Benzonatate 200 mg oral liquid-filled capsule · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-31; actual marketing, stock and availability are not established.
- benzonatate
- 200 mglabelled amount per capsule; must not generate individual use from this figure
- Package
- 500 capsules per bottle
United States label · Historical brand record in the current FDA Orange Book dataset
Historical brand 100 mg per capsule; currently an RX row in the Orange Book
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 011210 / Product 001
- Form and route
- TESSALON benzonatate 100 mg oral capsule · oral
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- benzonatate
- 100 mgamount per historical brand capsule; does not establish current brand stock
United States label · Historical brand record in the current FDA Orange Book dataset
Historical brand 200 mg per capsule; currently DISCN
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 011210 / Product 003
- Form and route
- TESSALON benzonatate 200 mg oral capsule · oral
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- benzonatate
- 200 mgamount per historical brand capsule; does not establish current brand stock
PACKAGE-VISUAL STATUS
The current generic label has capsule appearance text, but generic appearance is not presented as a TESSALON brand pack
The current label describes yellow oval soft-gelatin capsules for 100 mg and 200 mg, but appearance can differ by manufacturer, batch or market. The site does not show a pack image that cannot be matched one-to-one to all six identities; colour, shape or visible liquid alone cannot establish authenticity.
LABEL READING · NOT A PRESCRIPTION
Benzonatate enlarged label: swallow whole, oral numbness, child ingestion and overdose emergency
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
100 mg and 200 mg are strengths per capsule, not a capsule count per dose. The current label requires swallowing the capsule whole. Any child ingestion, suspected extra ingestion, seizure, coma, breathing problem or cardiac problem requires immediate local emergency or poison-centre help with the pack.
- Do not break, chew, dissolve, cut or crush the capsule. Release in the mouth can cause temporary oral or throat anaesthesia and choking. For swallowing difficulty, do not self-convert it to a liquid, squeeze it out or mix it with food; ask a pharmacist to review an available alternative.
- If the tongue, mouth, throat or face becomes numb or tingles, avoid food and liquids until the numbness resolves to reduce choking risk. Worsening, persistent symptoms or breathing difficulty requires immediate medical care.
- Accidental child ingestion has caused death. Overdose features can begin within 15–20 minutes and death has been reported within one hour. Do not watch and wait after any child ingestion or suspected overdose; immediately contact local emergency or poison services.
- Older adults, people with dysphagia or several medicines, and those with prior reactions to para-aminobenzoic-acid local anaesthetics such as procaine or tetracaine should review the exact pack and full medicine list. The site does not generate an individual plan from age, cough or milligrams.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-31
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. generic benzonatate 100 mg and 200 mg oral-capsule label (revised Jun 2026) ↗Current regulatory record · reviewed 2026-08-31
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Orange Book: TESSALON / benzonatate reference-brand record under NDA 011210 ↗reviewed 2026-08-29
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about TESSALON (benzonatate). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
TESSALON is the brand in this record and benzonatate is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. generic benzonatate 100 mg and 200 mg oral-capsule label (revised Jun 2026) ↗Current regulatory record · reviewed 2026-08-31
- FDA Orange Book: TESSALON / benzonatate reference-brand record under NDA 011210 ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How benzonatate reduces cough: peripheral anaesthesia of stretch receptors does not treat the cause
- This is a prescription antitussive dossier, not an antibacterial, and it does not treat every cause of cough. Breathing difficulty, chest pain, coughing blood, cyanosis, altered awareness or rapid deterioration requires immediate local emergency help.
- A similar purpose to dextromethorphan, codeine, an antihistamine or another cough/cold product does not permit self-conversion, combination or rotation by milligrams. Check every active ingredient and the complete medicine list first.
- The onset and duration described in the historical brand label are population-level label information, not a clock for this site to decide when an individual should make up, increase or add another cough medicine. Persistent or recurrent cough requires review of the cause and exact prescription.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. generic benzonatate 100 mg and 200 mg oral-capsule label (revised Jun 2026) ↗Current regulatory record · reviewed 2026-08-31
- FDA: historical TESSALON NDA 011210/S-053 brand label (2011; not a current label) ↗reviewed 2026-08-31
- FDA: TESSALON NDA 011210/S-053 supplemental approval letter for child-ingestion and overdose safety labelling (2011) ↗reviewed 2026-08-31
- FDA Orange Book: TESSALON / benzonatate reference-brand record under NDA 011210 ↗reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
TESSALONbenzonatate
This page links to public primary-source material for TESSALON. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval year
The historical FDA label states Initial U.S. Approval: 1958. This records the year only and does not infer an exact date, pack or current stock.
FDA: historical TESSALON NDA 011210/S-053 brand label (2011; not a current label) ↗TESSALON 200 mg brand strength approved
The Orange Book links Product 003, 200 mg, to NDA 011210. It is currently DISCN, with public data indicating no withdrawal for safety or effectiveness.
FDA Orange Book: TESSALON / benzonatate reference-brand record under NDA 011210 ↗FDA approved child-ingestion and overdose safety labelling
The NDA 011210/S-053 approval letter records labelling revisions addressing accidental child ingestion, overdose and poisoning risk.
FDA: TESSALON NDA 011210/S-053 supplemental approval letter for child-ingestion and overdose safety labelling (2011) ↗Current generic label revision
The current DailyMed page lists a benzonatate capsule label revised June 2026. It supports current safety reading and does not establish current stock of the historical brand.
DailyMed (NLM): current U.S. generic benzonatate 100 mg and 200 mg oral-capsule label (revised Jun 2026) ↗
MARKET SCOPE
Market-record boundary
United States
Historical brand reference record and current generic label shown separatelyThe TESSALON 100 mg Orange Book row remains RX, while the 200 mg row is DISCN. The four current NDCs shown are generic packs and are not presented as brand packs.
Mainland China, EU, Japan and other markets
Current market record not establishedNo local approval, trade name, supply, prescription status, originator/generic relationship or interchangeability is inferred from the U.S. NDA, brand or generic name.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Can a 100 mg capsule be bitten or half squeezed out to make 50 mg?
No. The label requires swallowing whole and says not to break, chew, dissolve, cut or crush it. Released contents can cause oral/throat anaesthesia and choking. Ask a pharmacist or prescriber to review an exact alternative product if a different plan is needed.
A child may have swallowed one capsule but has no symptoms. Can we watch first?
Do not wait for symptoms. Accidental child ingestion can become life-threatening rapidly. Immediately contact local emergency or poison services and take the exact pack; a webpage cannot rule out risk remotely.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.