Prescription and over-the-counter medicine
Fluticasone Brand names: Flonase, Flovent, Arnuity, Xhance; first approved as Cutivate
Fluticasone (Flonase) is a prescription and over-the-counter medicine with an FDA approval on record since 1990. FDA's NDC Directory lists it from 71 generic labelers, and pharmacies paid $0.243 per gram (Fluticasone prop 0.05% cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the fluticasone FDA label on DailyMed (effective December 19, 2024, Haleon US Holdings LLC); the NDA 19957 record on Drugs@FDA; every fluticasone label on DailyMed.
Highlights of the record
FDA label of December 19, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTemporarily relieves these symptoms of hay fever or other upper respiratory allergies:
nasal congestion
itchy nose
runny nose
itchy, watery eyes
sneezing
Forms and strengths
- 0.1g
- 0.05 mg/g
- 0.5 mg/g
- 0.5 mg/ml
Spray (metered); powder (metered); cream; aerosol (metered); ointment.
On the market
- Earliest approval on file
- December 14, 1990 Cutivate, Fougera; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 25 first May 14, 2004; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 76 of which 71 under generic applications, 6 under brand applications, repackagers included
- Last listed patent
- October 15, 2028 Flonase Sensimist Allergy Relief spray; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.243 per gram Fluticasone prop 0.05% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2018 0 Class I among all firms' recalls; latest February 14, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 139,949 through July 30, 2026
What is fluticasone used for?
From the label: indications and usageTemporarily relieves these symptoms of hay fever or other upper respiratory allergies:
nasal congestion
itchy nose
runny nose
itchy, watery eyes
sneezing
Conditions named in the indications of fluticasone's FDA labels, with every medicine labeled for each:
From other fluticasone labelsAllergies: Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
Asthma: Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older.
Eczema (atopic dermatitis): Fluticasone propionate lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age or older.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (FLONASE ALLERGY RELIEF), Haleon US Holdings LLC, effective December 19, 2024 (SPL set b6134ba0-b70a-4eac-9a82-cef64b242c1d), via openFDA; the full label on DailyMed
Is there a generic for fluticasone (Flonase)?
The FDA approved the first generic fluticasone on May 14, 2004. 25 generic applications are approved; 18 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists fluticasone from 71 labelers under a generic (ANDA) application and from 6 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 3 patents for Flonase Sensimist Allergy Relief spray, the last expiring on October 15, 2028; a patent listed only for Armonair Respiclick powder runs to January 6, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1990 earliest approval on file
- 2004 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluticasone (Flonase)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.243 per gram (Fluticasone prop 0.05% cream), about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fluticasone prop 0.05% cream (generic)
- Arnuity ellipta 100 mcg inhaler (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fluticasone ellipta 100 mcg inhaler | Generic | $4.28 per inhaler | n/a | +3% |
| Fluticasone ellipta 200 mcg inhaler | Generic | $5.71 per inhaler | n/a | -2% |
| Fluticasone ellipta 50 mcg inhaler | Generic | $4.22 per inhaler | n/a | +3% |
| Fluticasone prop 0.005% ointment | Generic | $0.433 per gram | n/a | -5% |
| Fluticasone prop 0.05% cream | Generic | $0.243 per gram | n/a | -0.1% |
| Fluticasone prop 0.05% lotion | Generic | $2.96 per mL | n/a | -0.6% |
| Fluticasone prop 100 mcg diskus | Generic | $2.05 per unit | n/a | -0.6% |
| Fluticasone prop 250 mcg disk | Generic | $2.69 per unit | n/a | +1% |
| Fluticasone prop 50 mcg diskus | Generic | $1.92 per unit | n/a | +0.6% |
| Fluticasone prop 50 mcg spray | Generic | $0.676 per gram | n/a | -10% |
| Fluticasone propionate hfa 110 mcg inhaler | Generic | $13.59 per gram | n/a | -0.5% |
| Fluticasone propionate hfa 220 mcg inhaler | Generic | $21.79 per gram | n/a | +1% |
| Fluticasone propionate hfa 44 mcg inhaler | Generic | $11.82 per gram | n/a | +2% |
| Ft allergy relief 50 mcg spray | Generic | $0.742 per mL | n/a | -1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fluticasone been recalled?
The FDA's Enforcement Report lists 6 recalls naming fluticasone since 2018: 0 Class I (the most serious), 6 Class II, 0 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of fluticasone and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 14, 2024 | Class II | Golden State Medical Supply Inc. | CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex |
| February 9, 2024 | Class II | Apotex Corp. | CGMP Deviations: potential presence of Burkholderia cepacia complex |
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| May 31, 2018 | Class II | Apotex Inc. | Presence of foreign substance: glass particles |
| February 9, 2018 | Class II | American Pharmaceutical Ingredients LLC not a listed maker | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fluticasone label say about other medicines?
The fluticasone label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 19 other medicines name fluticasone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions (prescription label) | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole) with XHANCE is not recommended because increased systemic corticosteroid adverse effects may occur. |
| Clarithromycin | drug interactions (prescription label) | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole) with XHANCE is not recommended because increased systemic corticosteroid adverse effects may occur. |
| Itraconazole | drug interactions (prescription label) | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole) with XHANCE is not recommended because increased systemic corticosteroid adverse effects may occur. |
| Ketoconazole | drug interactions (prescription label) | DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. |
| Nefazodone | drug interactions (prescription label) | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole) with XHANCE is not recommended because increased systemic corticosteroid adverse effects may occur. |
| Nelfinavir | drug interactions (prescription label) | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole) with XHANCE is not recommended because increased systemic corticosteroid adverse effects may occur. |
| Prednisone | warnings and precautions | Patients who have been previously maintained on 20 mg or more of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. |
| Ritonavir | drug interactions (prescription label) | DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. |
| Voriconazole | drug interactions (prescription label) | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole) with XHANCE is not recommended because increased systemic corticosteroid adverse effects may occur. |
Other labels that name fluticasone
Source: FDA drug label (FLONASE ALLERGY RELIEF), Haleon US Holdings LLC, effective December 19, 2024 (SPL set b6134ba0-b70a-4eac-9a82-cef64b242c1d), via openFDA; the full label on DailyMed
What do FAERS reports show for fluticasone?
The FDA Adverse Event Reporting System holds 139,949 reports that list fluticasone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,141 are coded as a death and 33,738 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as fluticasone?
7 other medicines are given the same way (nasal) and in the same FDA class as fluticasone or labeled mainly for the same use (allergies), the same class first. Allergies lists all 36 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (nasal) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Triamcinolone | Allergies | 24 labelers | $0.739 per mL 55 mcg nasal spr | Listed; available |
| Mometasone | Allergies | 5 labelers | $1.59 per gram 50 mcg spry | No current entry |
| Budesonide | Allergies | 5 labelers | $1.41 per mL 32 mcg nasal spray | No current entry |
| Beclomethasone | Allergies | none listed | $30.23 per gram 80 mcg nasal spray | No current entry |
| Mometasone and olopatadine | Allergies | none listed | $7.67 per gram 665-25 mcg spray | No current entry |
| Azelastine | Allergies | 16 labelers | $0.273 per mL 0.1% (137 mcg) spry | No current entry |
| Olopatadine | Allergies | 4 labelers | $0.850 per gram 665 mcg nasal spry | No current entry |
Every medicine labeled for the same conditions as fluticasone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fluticasone compare with medicines for the same use?
10 side-by-side pages set fluticasone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fluticasone
- 7 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Fluticasone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other