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Salmeterol Oral Inhalation

Salmeterol Oral Inhalation is a long-acting inhaled bronchodilator (LABA) used with an inhaled corticosteroid for asthma, to prevent exercise-induced bronchospasm, and for maintenance treatment of COPD.

Brand names SereventSerevent Diskus
Drug classes Adrenergic Beta2-agonists
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Salmeterol Oral Inhalation at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Salmeterol (Serevent Diskus), on the market since about 1994, is an older, twice-daily long-acting bronchodilator that relaxes the muscles around the airways, used for COPD, to prevent exercise-induced bronchospasm (airway tightening with exercise), and for asthma only alongside an inhaled corticosteroid. Most people tolerate it well, and headache, a stuffy nose or a sore throat are the usual complaints. Its boxed warning says that used for asthma without an inhaled corticosteroid, it raises the risk of asthma-related death, so never drop your steroid inhaler. It is never a rescue inhaler, so keep a short-acting one handy and call your doctor if you need it more often.

Clinical pearls

  • For exercise-induced bronchospasm, take your inhalation at least 30 minutes before activity, not once wheezing has started.
  • Never add another LABA-containing inhaler, such as a formoterol or indacaterol product, because doubling up can cause serious heart effects.
  • Clarithromycin, ritonavir, ketoconazole and itraconazole can raise salmeterol levels and heart risk, and beta-blockers can trigger severe bronchospasm.
  • The Diskus powder is off limits for anyone with a severe milk protein allergy.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Used alone for asthma (without an inhaled corticosteroid), salmeterol increases the risk of asthma-related death. In a large U.S. trial, there were 13 deaths among 13,176 people taking salmeterol versus 3 among 13,179 on placebo.

For that reason, Serevent Diskus is only for asthma that is not controlled on an inhaled corticosteroid, and must be used alongside one. It should not be used if asthma is well controlled on a low- or medium-dose ICS. When a LABA is combined with an ICS in one product, large trials did not show a significant increase in serious asthma events.

Children and teens are also at risk: LABA used alone raises the risk of asthma-related hospitalization. For people under 18 who need both, a combination inhaler is ordinarily preferred so both medicines are actually taken.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asInhalation powder
Earliest FDA record1994
Companies listing it with the FDA1
FDA label last updatedOct 10, 2022
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Salmeterol Oral Inhalation, written from its FDA label.

What Salmeterol Oral Inhalation is used for

▾

Salmeterol Oral Inhalation is a long-acting bronchodilator used for these conditions:

  • Asthma in people aged 4 and older, only as add-on to an inhaled corticosteroid (Serevent Diskus)
  • Prevention of exercise-induced bronchospasm in people aged 4 and older (Serevent Diskus)
  • Maintenance treatment of bronchospasm from COPD, including emphysema and chronic bronchitis (Serevent Diskus)

It is not for relief of sudden breathing symptoms.

How Salmeterol Oral Inhalation works

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Salmeterol is a selective long-acting beta-2 agonist. It stimulates beta-2 receptors in airway muscle, which raises cyclic AMP and relaxes the muscle so airways open.

It also reduces the release of inflammatory chemicals like histamine and leukotrienes from mast cells in lab studies. It acts locally in the lungs.

Salmeterol Oral Inhalation dosage

▾

Serevent Diskus is inhaled through the mouth only. For asthma and COPD, it is usually one inhalation twice daily, about 12 hours apart. For exercise-induced bronchospasm, it is used at least 30 minutes before exercise.

  • Do not take extra inhalations or use more often than directed.
  • Do not use other LABA medicines at the same time.
  • If you have asthma, keep using your inhaled corticosteroid.
  • Follow your prescriber's and the label's directions.

Dosing details from the FDA-approved label

From the Salmeterol Oral Inhalation prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Asthma in adults and children aged 4 years and older (in addition to concomitant ICS)
    • 1 inhalation (50 mcg) twice daily, approximately 12 hours apart
    • Maximum: More than 1 inhalation twice daily is not recommended
    • Use only as additional therapy for patients currently taking but inadequately controlled on an ICS; not for patients adequately controlled on low- or medium-dose ICS
  • Exercise-induced bronchospasm (EIB) prevention
    • 1 inhalation at least 30 minutes before exercise
    • Maximum: Additional doses should not be used for 12 hours after administration
    • Protection may last up to 9 hours in adults and adolescents and up to 12 hours in patients aged 4 to 11 years; patients receiving SEREVENT DISKUS twice daily should not use additional SEREVENT for EIB
  • Maintenance treatment of bronchospasm associated with COPD (including chronic bronchitis and emphysema) in adults
    • 1 inhalation (50 mcg) twice daily, approximately 12 hours apart
    • Maximum: More than 1 inhalation twice daily is not recommended
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION SEREVENT DISKUS should be administered by the orally inhaled route only. More frequent administration or a greater number of inhalations (more than 1 inhalation twice daily) is not recommended as some patients are more likely to experience adverse effects. Patients using SEREVENT DISKUS should not use additional LABA for any reason. [See Warnings and Precautions ( 5.4 , 5.6 ).] • For oral inhalation only. ( 2 ) • Treatment of asthma in patients aged 4 years and older: 1 inhalation twice daily in addition to concomitant treatment with an ICS. ( 2.1 ) • EIB: 1 inhalation at least 30 minutes before exercise. ( 2.2 ) • Maintenance treatment of bronchospasm associated with COPD: 1 inhalation twice daily. ( 2.3 ) 2.1 Asthma LABA, such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without ICS) increase the risk of asthma-related death [see Warnings and Precautions ( 5.1 )]. Because of this risk, use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an ICS is contraindicated. Use SEREVENT DISKUS only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS. Do not use SEREVENT DISKUS for patients whose asthma is adequately controlled on low- or medium-dose ICS. Pediatric and Adolescent Patients Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For patients with asthma younger than 18 years who require addition of a LABA to an ICS, a fixed-dose combination product containing both an ICS and a LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate ICS and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an ICS and a LABA is recommended. For bronchodilatation and prevention of symptoms of asthma, including the symptoms of nocturnal asthma, the usual dosage for adults and children aged 4 years and older is 1 inhalation (50 mcg) twice daily, approximately 12 hours apart.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Salmeterol Oral Inhalation side effects

▾

The most common side effects in studies were:

Common side effects

  • Headache
  • Nasal or sinus congestion
  • Runny nose (rhinitis)
  • Sore throat (pharyngitis)
  • Flu-like illness
  • Bronchitis or windpipe inflammation
  • Cough (in COPD)
  • Throat irritation (in COPD)
  • Muscle or joint pain (COPD)

When to get medical help

  • Get emergency help if your breathing suddenly gets worse right after a dose (paradoxical bronchospasm), or if you have stridor, choking, or throat swelling.
  • Seek emergency care for signs of a severe allergic reaction, such as hives, swelling, rash, or trouble breathing.
  • Call your doctor right away if your usual dose stops working or you need your rescue inhaler more often. This can mean your asthma is getting worse.
  • Call your doctor if you have chest pain, a very fast or irregular heartbeat, palpitations, or seizures.
  • Call your doctor if you notice shakiness, nervousness, or dizziness that is severe or doesn't settle.

Get medical help for sudden worsened breathing after a dose, allergic reactions, chest pain, or a racing or irregular heartbeat.

Salmeterol Oral Inhalation warnings and precautions

▾
  • Asthma-related death: salmeterol without an inhaled corticosteroid raises this risk in asthma.
  • Not for sudden symptoms: use a short-acting rescue inhaler instead. Do not start it during a rapidly worsening attack.
  • Not a steroid substitute: it has no proven anti-inflammatory effect.
  • Overuse risk: too much or combining with other LABAs can cause serious heart effects.
  • Paradoxical bronchospasm: airways can tighten after a dose. Stop and get help.
  • Heart and nervous system: can cause fast heartbeat, high or low blood pressure, tremor, and seizures. Use caution with heart disease, seizure disorders, thyroid overactivity, and diabetes.
  • Low potassium and high blood sugar can occur in some people.

Salmeterol Oral Inhalation interactions

▾

Several medicines can change how salmeterol works or affect your heart.

  • Strong CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, clarithromycin, others): raise salmeterol levels and heart risk. Not recommended.
  • MAO inhibitors and tricyclic antidepressants: may increase effects on blood vessels.
  • Beta-blockers: can block salmeterol and trigger severe bronchospasm.
  • Non-potassium-sparing diuretics: may worsen low potassium and ECG changes.
  • Other LABAs: risk of overdose.

Interactions listed in the FDA-approved label

From the Salmeterol Oral Inhalation prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin): Salmeterol is a CYP3A4 substrate; increased cardiovascular adverse effects may occur. With ketoconazole, salmeterol AUC increased 16-fold and Cmax 1.4-fold, with more frequent QTc increases. Use is not recommended.
  • Monoamine oxidase inhibitors and tricyclic antidepressants: The action of salmeterol on the vascular system may be potentiated. Administer with extreme caution, including within 2 weeks of discontinuing such agents.
  • Beta-adrenergic receptor blocking agents (beta-blockers): They block the pulmonary effect of beta-agonists and may produce severe bronchospasm in patients with asthma or COPD. Patients with asthma or COPD should not normally be treated with beta-blockers; if no acceptable alternative, cardioselective beta-blockers could be considered, with caution.
  • Non–potassium-sparing diuretics (such as loop or thiazide diuretics): ECG changes and/or hypokalemia can be acutely worsened by beta-agonists, especially when the recommended beta-agonist dose is exceeded. Use caution with coadministration.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of cardiovascular effects. ( 7.1 ) • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system. ( 7.2 ) • Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. ( 7.3 ) • Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists. ( 7.4 ) 7.1 Inhibitors of Cytochrome P450 3A4 Salmeterol is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with SEREVENT DISKUS is not recommended because increased cardiovascular adverse effects may occur. In a drug interaction trial in 20 healthy subjects, coadministration of inhaled salmeterol (50 mcg twice daily) and oral ketoconazole (400 mg once daily) for 7 days resulted in greater systemic exposure to salmeterol (AUC increased 16-fold and C max increased 1.4-fold). Three (3) subjects were withdrawn due to beta 2 -agonist side effects (2 with prolonged QTc and 1 with palpitations and sinus tachycardia). Although there was no statistical effect on the mean QTc, coadministration of salmeterol and ketoconazole was associated with more frequent increases in QTc duration compared with salmeterol and placebo administration. 7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants SEREVENT DISKUS should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of salmeterol on the vascular system may be potentiated by these agents.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Salmeterol Oral Inhalation

▾
  • Do not use for asthma without an inhaled corticosteroid.
  • Do not use with a severe milk protein allergy or known allergy to salmeterol or its ingredients.
  • Not for primary treatment of status asthmaticus or acute episodes needing intensive care.
  • Use caution with heart disease, seizure disorders, thyroid overactivity, or diabetes.
  • Liver disease: salmeterol may accumulate, so close monitoring is needed.
  • Pregnancy: studies have not identified a clear risk, but it may interfere with uterine contractions, so use in labor is limited. Poorly controlled asthma itself carries pregnancy risks.
  • Breastfeeding: levels in milk are likely low. Talk with your doctor.
  • Children and teens: those under 18 needing a LABA plus an ICS should ordinarily use a combination product.
  • Older adults: no dose change needed, but use caution with heart disease.

Salmeterol Oral Inhalation overdose

▾

Too much salmeterol causes excessive beta-stimulation: tremor, headache, fast or irregular heartbeat, chest pain, high or low blood pressure, nausea, muscle cramps, dry mouth, seizures, and changes in potassium and blood sugar. It can prolong the QTc interval, risking dangerous heart rhythms, and cardiac arrest or death may occur. Treatment is stopping the drug, symptom care, and cardiac monitoring. Seek emergency help.

What Salmeterol Oral Inhalation does in the body

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Like other beta agonists, inhaled salmeterol can raise heart rate and affect blood sugar and potassium in a dose-related way. Its heart-rate effects were similar to albuterol's. In studies, no clinically significant rhythm problems were seen at the usual dose, and in COPD, heart rate and blood pressure were similar to placebo.

How your body processes Salmeterol Oral Inhalation

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Salmeterol acts locally in the lungs, and blood levels at usual doses are very low or undetectable. It is broken down extensively in the liver, mainly by CYP3A4, and removed mostly in feces. The half-life was about 5.5 hours in one volunteer. Strong CYP3A4 blockers like ketoconazole can raise exposure sharply.

How to store Salmeterol Oral Inhalation

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Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) . Store in a dry place away from direct heat or sunlight. Keep out of reach of children.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

141

Supplements & herbs that interact with Salmeterol Oral Inhalation

141 supplements and herbal products have documented interactions with Salmeterol Oral Inhalation in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 7
  • Moderate · 105
  • Minor · 29
Every supplement checked against Salmeterol Oral Inhalation — ranked by severity The full interaction hub: 7 major · 105 moderate · 29 minor · every one linked to its full report. Check Salmeterol Oral Inhalation against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Salmeterol Oral Inhalation: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Salmeterol Oral Inhalation — the kind of thing our pharmacy team would talk through with you at the counter.

Can I use this inhaler when I'm suddenly short of breath?

▾
No. Serevent Diskus is a maintenance medicine and does not work fast enough for sudden symptoms. Use your short-acting rescue inhaler, such as albuterol, instead. If you need rescue more often, call your doctor.

Do I still need my steroid inhaler for asthma?

▾
Yes. Salmeterol does not treat airway inflammation, and using it for asthma without an inhaled corticosteroid is contraindicated because of the risk of asthma-related death. Keep taking your steroid even if you feel better, and only change it after talking with your doctor.

How do I take it?

▾
You breathe it in through your mouth, usually one inhalation twice a day about 12 hours apart. For exercise-induced symptoms, it is one inhalation at least 30 minutes before exercise. Don't take extra puffs, and follow your prescriber's directions.

What side effects should I expect?

▾
Headache, stuffy or runny nose, and sore throat are common. With COPD, cough and throat irritation can happen. Call your doctor for chest pain, a racing heartbeat, or worsening breathing, and get emergency help for swelling or trouble breathing.

Are there medicines I should avoid with it?

▾
Yes. Strong CYP3A4 blockers like ketoconazole and ritonavir aren't recommended. Beta-blockers, MAO inhibitors, tricyclic antidepressants, and certain diuretics need caution. Never combine it with another LABA. Tell me about everything you take.

Is it safe in pregnancy or for my child?

▾
Studies haven't identified a clear pregnancy risk, but it can affect uterine contractions, so tell your doctor. It is approved for ages 4 and up. For children and teens with asthma, a combination inhaler with a steroid is ordinarily preferred.

Is Salmeterol Oral Inhalation available over the counter?

▾
No. Salmeterol Oral Inhalation is a prescription medicine: every Salmeterol Oral Inhalation product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Salmeterol Oral Inhalation first available?

▾
The earliest FDA record we hold for Salmeterol Oral Inhalation is from 1994: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Salmeterol Oral Inhalation was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Salmeterol Oral Inhalation on HelloPharmacist

Detailed data & references for Salmeterol Oral Inhalation Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Salmeterol Oral Inhalation forms and strengths (how it comes)

Salmeterol Oral Inhalation is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Inhalation powder

By mouth · Inhaled
Brands Serevent
How this form is used
What it may be used for
  • Serevent Diskus is used for asthma in people 4 and older, only along with an inhaled corticosteroid.
  • Serevent Diskus is used to prevent exercise-induced bronchospasm in people 4 and older.
  • Serevent Diskus is used for maintenance treatment of bronchospasm in COPD.
Important instructions
  • Serevent Diskus is for oral inhalation only.
  • Serevent Diskus for asthma or COPD is one inhalation twice daily, about 12 hours apart.
  • Serevent Diskus for exercise-induced bronchospasm is one inhalation at least 30 minutes before exercise, with no extra doses for 12 hours.
  • Serevent Diskus users should not use any other LABA medicine.
Available strengths 1 strength
4 FDA-listed product records ⓘ

Salmeterol Oral Inhalation on the U.S. market: products, makers and brands

How Salmeterol Oral Inhalation appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 1 Salmeterol Oral Inhalation product record with the FDA, mostly as inhalation powder; the earliest marketing or approval year on record is 1994. Brand names on the directory include Serevent, Serevent Diskus; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
2
Brand names
1
FDA-listed product records ⓘ
1994
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Salmeterol Oral Inhalation is used (Medicaid data)

A general measure of how commonly Salmeterol Oral Inhalation is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Salmeterol Oral Inhalation is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

15,481
Medicaid prescriptions filled (Q1–Q4 2025)
$7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Salmeterol Oral Inhalation prescribed? Of the 1,601 medications we measure, Salmeterol Oral Inhalation ranks #848 by Medicaid prescriptions — more than 47% of them.

Where Salmeterol Oral Inhalation ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Salmeterol Oral Inhalation product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

60 ACTUAT salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler

15,481 Medicaid prescriptions (Q1–Q4 2025) 100% of Salmeterol Oral Inhalation prescriptions shown $7M gross reimbursement (before rebates) ≈ $453 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 866048

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Salmeterol Oral Inhalation, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Salmeterol Oral Inhalation NDCs with Medicaid activity.

Compare Salmeterol Oral Inhalation products

A representative set of FDA-listed product records for Salmeterol Oral Inhalation — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Inhalation powder
50 mcg Oral, Respiratory (inhalation) GlaxoSmithKline LLC NDA View NDC →

Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Salmeterol Oral Inhalation NDCs →

Salmeterol Oral Inhalation recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Salmeterol recalls since July 2021.

✅No Salmeterol recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Salmeterol Oral Inhalation RxCUI 36117 1 dose form · 1 strength

Look up RxCUI 36117 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Salmeterol Oral Inhalation costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Powder, Metered · Oral; Respiratory (inhalation) 50 mcg $6.74 each NDC details & price history
Powder, Metered · Oral, Respiratory (inhalation) 50 mcg $6.74 each NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Salmeterol Oral Inhalation brand names

Salmeterol Oral Inhalation is sold under 2 brand names in the FDA directory — Serevent, Serevent Diskus. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Serevent Serevent Diskus

Who makes Salmeterol Oral Inhalation: manufacturers and labelers

One company lists Salmeterol Oral Inhalation products with the FDA. By number of product records, the largest are GlaxoSmithKline LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

GlaxoSmithKline LLC 1

Salmeterol Oral Inhalation drug class (RxNorm)

Salmeterol Oral Inhalation belongs to the beta2-Adrenergic Agonist class.

Pharmacologic class beta2-Adrenergic Agonist
Drug family (ATC) Selective beta-2-adrenoreceptor agonists
How it works Adrenergic beta2-Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Salmeterol Oral Inhalation page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 10, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Salmeterol Oral Inhalation.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Salmeterol Oral Inhalation after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
1
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
GlaxoSmithKline LLC
Linked label effective
Oct 10, 2022
Composite sections available
24
Linked SPL Set ID
12d9728e-6b5c-4aee-bfb0-745e542ed2e4
Linked SPL Document ID
5532804f-f5b5-492b-a092-0b1ce60c8de1
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. GlaxoSmithKline LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →