Fluticasone and Salmeterol Oral Inhalation
Fluticasone and salmeterol is an inhaled combination of a corticosteroid and a long-acting bronchodilator, used twice daily to treat asthma and, in the powder form, to manage COPD.
🧬 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 34 clinical label sets 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 →
Fluticasone and salmeterol is a twice-daily controller inhaler for asthma and, in the powder form, COPD, pairing a steroid that calms airway inflammation with a long-acting bronchodilator (LABA) that keeps airways open; it is a familiar next step when an inhaled steroid alone is not enough, on the market since about 2001 and available generically. Most people tolerate it well, and the usual complaints are hoarseness, a sore throat and thrush (a mouth yeast infection). It is not a rescue inhaler, so keep a short-acting one for sudden symptoms, and needing that rescue inhaler more often is your cue to call your prescriber.
Clinical pearls
- Rinse your mouth with water and spit it out, never swallow, after every dose to lower the chance of thrush.
- Never pair it with another LABA such as formoterol or arformoterol, since doubling up risks serious heart effects.
- Tell every prescriber you use it, since ritonavir and ketoconazole raise its effects and beta-blockers can trigger severe airway tightening.
- With COPD, pneumonia can look like a flare-up, so report fever, chills or a change in mucus promptly.
Patient information guide A plain-language walkthrough of Fluticasone and Salmeterol Oral Inhalation, written from its FDA label.
What Fluticasone and Salmeterol Oral Inhalation is used for
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This combination of a corticosteroid and a long-acting bronchodilator is used for:
- Asthma: twice-daily treatment in people aged 4 years and older who need an inhaled steroid plus a LABA.
- COPD (inhalation powder, 250/50 strength only): maintenance treatment of airflow obstruction, including chronic bronchitis and emphysema, and reducing flare-ups in people with a history of them.
- Not for relief of sudden bronchospasm.
How Fluticasone and Salmeterol Oral Inhalation works
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Fluticasone is a corticosteroid that reduces airway inflammation, a key part of asthma. Salmeterol is a long-acting beta agonist that relaxes the muscles around the airways and also blocks release of inflammatory substances from mast cells. Together they help keep airways open and calmer.
Fluticasone and Salmeterol Oral Inhalation dosage
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The inhalation powder is taken by mouth inhalation only, one inhalation twice daily, about 12 hours apart.
- Rinse your mouth with water afterward and spit it out.
- Do not take more than one inhalation twice daily.
- Use a short-acting rescue inhaler for symptoms between doses.
- If you used a short-acting beta agonist on a regular schedule, ask your prescriber about stopping that routine.
Follow your prescriber's directions and the product label.
Dosing details from the FDA-approved label
From the Fluticasone and 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 patients aged 12 years and older
- 1 inhalation of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg, 250 mcg/50 mcg, or 500 mcg/50 mcg twice daily, approximately 12 hours apart
- Starting dosage is based on asthma severity
- Maximum: 500 mcg/50 mcg twice daily
- If a patient does not respond adequately after 2 weeks of therapy, replacing the current strength with a higher strength may provide additional improvement
- Asthma in pediatric patients aged 4 to 11 years
- 1 inhalation of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg twice daily, approximately 12 hours apart
- For patients not controlled on an ICS
- Maintenance treatment of chronic obstructive pulmonary disease (COPD)
- 1 inhalation of fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg twice daily, approximately 12 hours apart
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Fluticasone propionate and salmeterol inhalation powder should be administered as 1 inhalation twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. More frequent administration or a greater number of inhalations (more than 1 inhalation twice daily) of the prescribed strength of fluticasone propionate and salmeterol inhalation powder is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using fluticasone propionate and salmeterol inhalation powder should not use additional LABA for any reason [see Warnings and Precautions ( 5.3 , 5.12 )] . • For oral inhalation only. ( 2 ) • Treatment of Asthma in Patients Aged 12 Years and Older: 1 inhalation of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, or fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg twice daily. Starting dosage is based on asthma severity. ( 2.1 ) • Treatment of Asthma in Patients Aged 4 to 11 Years: 1 inhalation of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg twice daily. ( 2.1 ) • Maintenance Treatment of COPD: 1 inhalation of fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg twice daily. ( 2.2 ) 2.1 Asthma If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief. Adult and Adolescent Patients Aged 12 Years and Older For patients aged 12 years and older, the dosage is 1 inhalation twice daily, approximately 12 hours apart. When choosing the starting dosage strength of fluticasone propionate and salmeterol inhalation powder, consider the patients’ disease severity, based on their previous asthma therapy, including the ICS dosage, as well as the patients’ current control of asthma symptoms and risk of future exacerbation. The maximum recommended dosage is fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg twice daily.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Fluticasone and Salmeterol Oral Inhalation side effects
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Common side effects include:
Common side effects
- Upper respiratory infections or inflammation
- Sore throat (pharyngitis)
- Hoarseness or voice changes (dysphonia)
- Yeast infection in the mouth (oral candidiasis)
- Cough or bronchitis
- Headache
- Nausea and vomiting
- Pneumonia in people with COPD
- Muscle or joint pain (COPD)
When to get medical help
- Get help right away if your breathing suddenly worsens right after a dose (paradoxical bronchospasm). Stop the medicine and call your doctor.
- Call your doctor if your asthma or COPD is getting worse or you need your rescue inhaler more often.
- Call your doctor if you have signs of pneumonia, especially with COPD, since symptoms can resemble a flare-up.
- Call your doctor about white patches or soreness in your mouth or throat, which can be a yeast infection.
- Seek care for a fast or pounding heartbeat, chest pain, tremor or severe nervousness.
- Tell your doctor about vision changes or eye symptoms, since glaucoma and cataracts can occur with long-term inhaled corticosteroids.
- Contact your doctor if you are exposed to chickenpox or measles, which can be more serious while using corticosteroids.
Seek help for sudden worsening breathing after a dose, signs of pneumonia, fast or irregular heartbeat, or vision changes.
Fluticasone and Salmeterol Oral Inhalation warnings and precautions
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- LABA risk: salmeterol alone for asthma raises the risk of asthma-related death. Combined with a steroid, this was not significantly increased in large trials.
- Not for emergencies: do not start it during a rapidly worsening attack.
- Overuse: too many doses or other LABAs can cause serious heart effects.
- Pneumonia in COPD and mouth yeast infections.
- Steroid effects: immune suppression, adrenal suppression, lower bone density, slowed growth in children, glaucoma and cataracts.
- Paradoxical bronchospasm: stop and seek help if breathing worsens right after a dose.
Fluticasone and Salmeterol Oral Inhalation interactions
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Several medicines can change how this one works or add risk:
- Strong CYP3A4 inhibitors (ritonavir, ketoconazole): raise steroid and heart-related effects.
- Other LABAs: overdose risk.
- MAO inhibitors and tricyclic antidepressants: can strengthen salmeterol's effects on blood vessels.
- Beta-blockers: may block the benefit and cause bronchospasm.
- Non-potassium-sparing diuretics: may worsen low potassium or ECG changes.
Interactions listed in the FDA-approved label
From the Fluticasone and 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): May increase systemic corticosteroid and cardiovascular adverse effects. Use is not recommended.
- Monoamine oxidase inhibitors and tricyclic antidepressants: The action of salmeterol on the vascular system may be potentiated by these agents. Administer with extreme caution, including within 2 weeks of discontinuation of such agents.
- Beta-adrenergic receptor blocking agents (beta-blockers): They block the pulmonary effect of beta-agonists such as salmeterol 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 there is no acceptable alternative, cardioselective beta-blockers could be considered, administered with caution.
- Non-potassium-sparing diuretics (such as loop or thiazide diuretics): ECG changes and/or hypokalemia can be acutely worsened by beta-agonists such as salmeterol, especially when the recommended dose of the beta-agonist is exceeded. Use caution with coadministration.
- Short-acting beta2-agonists, methylxanthines, and intranasal corticosteroids: Used concomitantly in patients with asthma or COPD without adverse drug reactions.
Read the label’s full interactions text
7 DRUG INTERACTIONS Fluticasone propionate and salmeterol inhalation powder has been used concomitantly with other drugs, including short-acting beta 2 -agonists, methylxanthines, and intranasal corticosteroids, commonly used in patients with asthma or COPD without adverse drug reactions [see Clinical Pharmacology (12.2) ] . No formal drug interaction trials have been performed with fluticasone propionate and salmeterol inhalation powder. • Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid and 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 Fluticasone propionate and salmeterol, the individual components of Wixela Inhub ® , are substrates of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Wixela Inhub ® is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur. Ritonavir Fluticasone Propionate A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology (12.3) ] .
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 Fluticasone and Salmeterol Oral Inhalation
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- Do not use for sudden asthma or COPD attacks.
- Avoid if you have a severe milk protein allergy or allergy to its ingredients.
- Use with caution with heart or nervous system disorders, seizures, thyroid overactivity, diabetes or ketoacidosis.
- Use with caution with active infections such as tuberculosis or eye herpes.
- Tell your doctor if pregnant or breastfeeding.
- Children need growth monitoring.
- Older adults with COPD had more pneumonia.
- Tell your doctor about liver problems.
Fluticasone and Salmeterol Oral Inhalation overdose
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Too much can cause excess beta-stimulation: fast or irregular heartbeat, tremor, nervousness, headache, chest pain, muscle cramps, seizures, and QTc prolongation that can lead to dangerous heart rhythms. Long-term steroid excess can cause signs of hypercorticism. Treatment is to stop the medicine and give supportive care with cardiac monitoring.
What Fluticasone and Salmeterol Oral Inhalation does in the body
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At recommended doses, salmeterol's body-wide effects (pulse, blood pressure, QTc, potassium and glucose) were not significantly different when given in this combination versus alone. In studies, the combination did not significantly change cortisol measures versus fluticasone alone in most people. No clinically significant dysrhythmias were seen in monitored people with asthma.
How your body processes Fluticasone and Salmeterol Oral Inhalation
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Both drugs act locally in the lungs, so blood levels do not predict benefit. Fluticasone peaks in about 1 to 2 hours, and swallowed fluticasone is barely absorbed (under 1%). Salmeterol peaks in about 5 minutes, and blood levels are low or undetectable at recommended doses. Salmeterol is also processed by the CYP3A4 enzyme.
How to store Fluticasone and 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 →
Fluticasone and Salmeterol Oral Inhalation: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Fluticasone and Salmeterol Oral Inhalation — the kind of thing our pharmacy team would talk through with you at the counter.
What is this inhaler for?
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How do I use it?
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What if I feel short of breath between doses?
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What side effects should I expect?
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Can I take it with my other medicines?
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Is it safe in pregnancy?
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Is Fluticasone and Salmeterol Oral Inhalation available over the counter?
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When was Fluticasone and Salmeterol Oral Inhalation first available?
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Who makes Fluticasone and Salmeterol Oral Inhalation?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Fluticasone and Salmeterol Oral Inhalation on HelloPharmacist
Fluticasone and Salmeterol Oral Inhalation forms and strengths (how it comes)
Fluticasone and Salmeterol Oral Inhalation is available in 2 forms. 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Fluticasone and Salmeterol Oral Inhalation inactive ingredients by manufacturer.
Inhalation powder
How this form is used
- Wixela Inhub is used for twice-daily treatment of asthma in people aged 4 years and older.
- Wixela Inhub is used for maintenance treatment of COPD, including reducing exacerbations in people with a history of them.
- Wixela Inhub is for oral inhalation only, one inhalation twice daily about 12 hours apart.
- With Wixela Inhub, rinse your mouth with water after use and do not swallow the water.
- Wixela Inhub should not be used for sudden breathing symptoms.
Show 4 more strengths Show fewer strengths
Inhaler
Fluticasone and Salmeterol Oral Inhalation on the U.S. market: products, makers and brands
How Fluticasone and 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.
13 companies list 58 Fluticasone and Salmeterol Oral Inhalation product records with the FDA, mostly as inhalation powder, inhaler; the earliest marketing or approval year on record is 2001. Brand names on the directory include Advair Diskus, Advair Hfa, AirDuo RespiClick and 4 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Fluticasone and Salmeterol Oral Inhalation is used (Medicaid data)
A general measure of how commonly Fluticasone and 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 Fluticasone and 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.
How commonly is Fluticasone and Salmeterol Oral Inhalation prescribed? Of the 1,601 medications we measure, Fluticasone and Salmeterol Oral Inhalation ranks #120 by Medicaid prescriptions — more than 93% of them.
Utilization by Fluticasone and 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 fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler Most dispensed
Summed across the 5 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896209
60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler
Summed across the 5 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896184
60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler
Summed across the 5 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896228
120 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896244
120 ACTUAT fluticasone propionate 0.23 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler
Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896272
120 ACTUAT fluticasone propionate 0.045 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler
Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896236
60 ACTUAT fluticasone propionate 0.232 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1918203
60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1918194
60 ACTUAT fluticasone propionate 0.055 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1918209
60 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896239
60 ACTUAT fluticasone propionate 0.23 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896267
60 ACTUAT fluticasone propionate 0.045 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896231
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 Fluticasone and 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 30 of 66 listed Fluticasone and Salmeterol Oral Inhalation NDCs with Medicaid activity.
Compare Fluticasone and Salmeterol Oral Inhalation products
A representative set of FDA-listed product records for Fluticasone and 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 | ||||
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 100 mcg | Respiratory (inhalation) | A-S Medication Solutions × 2 listings | NDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 250 mcg | Respiratory (inhalation) | A-S Medication Solutions × 2 listings | NDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 500 mcg | Respiratory (inhalation) | A-S Medication Solutions × 2 listings | NDA | View NDC → |
| FLUTICASONE PROPIONATE 55 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | A-S Medication Solutions | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 100 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | A-S Medication Solutions | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 113 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | A-S Medication Solutions | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 232 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | A-S Medication Solutions | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 250 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | A-S Medication Solutions | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 500 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | A-S Medication Solutions | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 55 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 113 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 232 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 250 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Bryant Ranch Prepack | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 100 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Cipla USA Inc. | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 250 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Cipla USA Inc. | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 500 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Cipla USA Inc. | ANDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 100 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC | NDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 250 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC | NDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 500 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC | NDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 100 mcg | Respiratory (inhalation) | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 250 mcg | Respiratory (inhalation) | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 500 mcg | Respiratory (inhalation) | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 100 mcg | Respiratory (inhalation) | Lannett Company, Inc. | ANDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 250 mcg | Respiratory (inhalation) | Lannett Company, Inc. | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 100 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 250 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 500 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 100 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 250 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 500 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 100 mcg | Respiratory (inhalation) | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 250 mcg | Respiratory (inhalation) | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 250 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Proficient Rx LP | NDA AUTHORIZED GENERIC | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 100 mcg | Respiratory (inhalation) | Remedyrepack Inc. | ANDA | View NDC → |
| SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 250 mcg | Respiratory (inhalation) | Remedyrepack Inc. | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 100 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Remedyrepack Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 250 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Remedyrepack Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 500 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Remedyrepack Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 55 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 100 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 113 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 232 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 250 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 500 mcg/1; SALMETEROL XINAFOATE 50 mcg | Respiratory (inhalation) | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| FLUTICASONE PROPIONATE 55 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | Teva Respiratory, LLC | NDA | View NDC → |
| FLUTICASONE PROPIONATE 113 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | Teva Respiratory, LLC | NDA | View NDC → |
| FLUTICASONE PROPIONATE 232 mcg/1; SALMETEROL XINAFOATE 14 mcg | Respiratory (inhalation) | Teva Respiratory, LLC | NDA | View NDC → |
| 💊Inhaler | ||||
| FLUTICASONE PROPIONATE 115 mcg/1; SALMETEROL XINAFOATE 21 mcg | Respiratory (inhalation) | A-S Medication Solutions × 2 listings | NDA | View NDC → |
| FLUTICASONE PROPIONATE 45 mcg/1; SALMETEROL XINAFOATE 21 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC | NDA | View NDC → |
| FLUTICASONE PROPIONATE 115 mcg/1; SALMETEROL XINAFOATE 21 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC | NDA | View NDC → |
| FLUTICASONE PROPIONATE 230 mcg/1; SALMETEROL XINAFOATE 21 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC | NDA | View NDC → |
| FLUTICASONE PROPIONATE 45 mcg/1; SALMETEROL XINAFOATE 21 mcg | Respiratory (inhalation) | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 115 mcg/1; SALMETEROL XINAFOATE 21 mcg | Respiratory (inhalation) | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE PROPIONATE 230 mcg/1; SALMETEROL XINAFOATE 21 mcg | Respiratory (inhalation) | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
Showing 58 of 58 products — FDA National Drug Code Directory. See every product, package size and price: browse all 58 Fluticasone and Salmeterol Oral Inhalation NDCs →
Fluticasone and Salmeterol Oral Inhalation side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fluticasone and Salmeterol Oral Inhalation — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fluticasone and Salmeterol Oral Inhalation in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Fluticasone and Salmeterol Oral Inhalation FDA approval history
How Fluticasone and Salmeterol Oral Inhalation went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Fluticasone and 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 Fluticasone and Salmeterol recalls since July 2021.
✅No Fluticasone and Salmeterol recalls on record since July 2021Source: 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 exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 284635 2 dose forms · 18 strengths
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Dose form (SCDF) Dry Powder Inhaler RxCUI 746717In current FDA listingsClinical drug / strength (SCD) Sensor 60 ACTUAT fluticasone propionate 0.055 MG/ACTUAT / salmeterol 0.014 MG/ACTUATRxCUI 2395829Sensor 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUATRxCUI 2395826Sensor 60 ACTUAT fluticasone propionate 0.232 MG/ACTUAT / salmeterol 0.014 MG/ACTUATRxCUI 239583214 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUATRxCUI 89616114 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUATRxCUI 89618614 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUATRxCUI 89621860 ACTUAT fluticasone propionate 0.055 MG/ACTUAT / salmeterol 0.014 MG/ACTUATRxCUI 191820960 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUATRxCUI 89618460 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUATRxCUI 191819460 ACTUAT fluticasone propionate 0.232 MG/ACTUAT / salmeterol 0.014 MG/ACTUATRxCUI 191820360 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUATRxCUI 89620960 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUATRxCUI 896228 -
Dose form (SCDF) Metered Dose Inhaler RxCUI 744485In current FDA listingsClinical drug / strength (SCD) 60 ACTUAT fluticasone propionate 0.045 MG/ACTUAT / salmeterol 0.021 MG/ACTUATRxCUI 89623160 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUATRxCUI 89623960 ACTUAT fluticasone propionate 0.23 MG/ACTUAT / salmeterol 0.021 MG/ACTUATRxCUI 896267120 ACTUAT fluticasone propionate 0.045 MG/ACTUAT / salmeterol 0.021 MG/ACTUATRxCUI 896236120 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUATRxCUI 896244120 ACTUAT fluticasone propionate 0.23 MG/ACTUAT / salmeterol 0.021 MG/ACTUATRxCUI 896272
Look up RxCUI 284635 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.
Fluticasone and Salmeterol Oral Inhalation supply and shortage status
Whether Fluticasone and Salmeterol Oral Inhalation is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Fluticasone and 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.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Powder · Respiratory (inhalation) | 250; 50 mcg/1; mcg | $1.25 each | NDC details & price history |
| Powder · Respiratory (inhalation) | FLUTICASONE PROPIONATE 250 mcg/1; SALMETEROL XINAFOATE 50 mcg | $1.25 each | NDC details & price history |
| Powder · Respiratory (inhalation) | SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 100 mcg | $1.07 each | NDC details & price history |
| Powder · Respiratory (inhalation) | SALMETEROL XINAFOATE 50 mcg/1; FLUTICASONE PROPIONATE 250 mcg | $1.25 each | NDC details & price history |
| Powder · Respiratory (inhalation) | 100; 50 mcg/1; mcg | $1.07 each | NDC details & price history |
| Powder · Respiratory (inhalation) | FLUTICASONE PROPIONATE 500 mcg/1; SALMETEROL XINAFOATE 50 mcg | $1.64 each | NDC details & price history |
| Powder · Respiratory (inhalation) | FLUTICASONE PROPIONATE 100 mcg/1; SALMETEROL XINAFOATE 50 mcg | $1.07 each | NDC details & price history |
| Powder · Respiratory (inhalation) | 500; 50 mcg/1; mcg | $1.64 each | NDC details & price history |
| Powder, Metered · Respiratory (inhalation) | 232; 14 mcg/1; mcg | $105.32 each | NDC details & price history |
| Powder, Metered · Respiratory (inhalation) | 113; 14 mcg/1; mcg | $108.28 each | NDC details & 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.
Fluticasone and Salmeterol Oral Inhalation brand names
Fluticasone and Salmeterol Oral Inhalation is sold under 7 brand names in the FDA directory — Advair Diskus, Advair Hfa, AirDuo RespiClick, Fluticasone Propionate and Salmeterol DISKUS and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Fluticasone and Salmeterol Oral Inhalation: manufacturers and labelers
13 companies list Fluticasone and Salmeterol Oral Inhalation products with the FDA. By number of product records, the largest are A-S Medication Solutions, GlaxoSmithKline LLC, Prasco Laboratories. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Fluticasone and Salmeterol Oral Inhalation drug class (RxNorm)
Fluticasone and Salmeterol Oral Inhalation belongs to the beta2-Adrenergic Agonist class.
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 Fluticasone and 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.
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. A-S Medication Solutions 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 →