FDA-filed SPL labeling · retrieved through openFDA

Fluticasone

XHANCE is a corticosteroid indicated for the treatment of: Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.

Brand names ArnuityAller-FloClarisprayFlonaseFlonase Sensimist +11 more
Drug class Corticosteroid Hormone Receptor Agonists
Rx/OTC Forms 6 Routes Nasal · Respiratory (inhalation) · Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 119 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 →

At a glance
Linked label effectiveApr 9, 2019
Clinical labels in scope 119
AvailabilityRx/OTC
Earliest approval/marketing year 1990
FDA-listed product records 505
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 19, 2026 🚨Recall on record · 2
Other forms & routes:

Key facts about Fluticasone

🎯What it's used for

1 INDICATIONS AND USAGE XHANCE is a corticosteroid indicated for the treatment of: Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. ( 1.1 ) Chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.

Read the full label section on DailyMed →
⏱️How it's taken

2 DOSAGE AND ADMINISTRATION Recommended Dosage : 186 mcg (1 spray per nostril) or 372 mcg (2 sprays per nostril) twice daily. ( 2.1 ) For nasal use only. Shake before use. Prime before initial use.

Read the full label section on DailyMed →
🤒Common side effects

6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: 1. Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired wound healing [see Warnings and Precautions ( 5.1 )] 2.

Read the full label section on DailyMed →
🛑Key warnings

5 WARNINGS AND PRECAUTIONS Local Nasal Adverse Reactions: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa.

Read the full label section on DailyMed →
📦How to store it

Store between 4° and 30°C (39° and 86°F).

Drawn from the manufacturer’s FDA-filed label. Read the official label on DailyMed →

Fluticasone: frequently asked questions

Common questions about Fluticasone, answered from its official FDA-filed labeling.

What is Fluticasone used for?
1 INDICATIONS AND USAGE XHANCE is a corticosteroid indicated for the treatment of: Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. ( 1.1 ) Chronic rhinosinusitis without nasal polyps (CRSsNP) in adults. ( 1.2 ) 1.1 Chronic Rhinosinusitis with Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. 1.2 Chronic Rhinosinusitis without Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.
How is Fluticasone taken?
2 DOSAGE AND ADMINISTRATION Recommended Dosage : 186 mcg (1 spray per nostril) or 372 mcg (2 sprays per nostril) twice daily. ( 2.1 ) For nasal use only. Shake before use. Prime before initial use. ( 2.2 ) XHANCE is delivered into the nose by actuating the pump spray into one nostril while simultaneously blowing into the mouthpiece of the device. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of XHANCE is 186 mcg (1 spray per nostril) or 372 mcg (2 sprays per nostril) twice daily (total daily dose of 372 mcg or 744 mcg).
What are the side effects of Fluticasone?
6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: 1. Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired wound healing [see Warnings and Precautions ( 5.1 )] 2. Glaucoma and cataracts [see Warnings and Precautions ( 5.2 )] 3. Immunosuppression [see Warnings and Precautions ( 5.4 )] 4. Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.5 )] 5.
What should I know before taking Fluticasone?
5 WARNINGS AND PRECAUTIONS Local Nasal Adverse Reactions: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma. ( 5.1 ) Glaucoma and Cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.
Can I take Fluticasone while pregnant?
8.1 Pregnancy Risk Summary There are insufficient data on the use of fluticasone propionate nasal spray in pregnant women to inform a drug-associated risk. In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, were observed in rats, mice, and rabbits with subcutaneously administered maternal toxic doses of fluticasone propionate 5 times, equivalent to, and less than the maximum recommended human daily intranasal dose (MRHDID) on a mcg/m 2 basis, respectively. (See Animal Data .
How should I store Fluticasone?
Store between 4° and 30°C (39° and 86°F).
Is Fluticasone available over the counter?
Both — Fluticasone is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Fluticasone first available?
Fluticasone has been available in the United States since at least 1990, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Fluticasone?
Fluticasone is supplied by 138 manufacturers listed in the FDA NDC Directory, including A-S Medication Solutions, GlaxoSmithKline LLC, Prasco Laboratories.

💬 Answers drafted from Fluticasone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Fluticasone comes

Fluticasone is available in 6 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.

Nasal spray

In the nose
Brands Allergy Relief Flonase Flonase Sensimist
Available strengths 4 strengths
322 FDA-listed product records

Topical cream, ointment or gel

On the skin
Available strengths 3 strengths
42 FDA-listed product records

Spray

By mouth
Available strengths 2 strengths
3 FDA-listed product records

Injection

By injection
Available strengths 1 strength
1 FDA-listed product record

📊 Fluticasone across the U.S. market

How Fluticasone 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.

6
Dose forms
138
Manufacturers
40
Brand names
505
FDA-listed product records
1990
First marketed

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (46) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions11%
GlaxoSmithKline LLC7%
Prasco Laboratories6%
Bryant Ranch Prepack6%
Apotex Corp.4%
CVS Pharmacy3%
Other makers62%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Fluticasone is used

A general measure of how commonly Fluticasone 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 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.

11,068,970
Medicaid prescriptions filled (Q1–Q4 2025)
$497.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fluticasone prescribed? Of the 1,596 medications we measure, Fluticasone ranks #8 by Medicaid prescriptions — more than 99% of them.

Where Fluticasone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Fluticasone 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.

The 0.05 mg/actuation metered dose nasal spray is the most-dispensed Fluticasone product — about 83% of these Medicaid prescriptions.

fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray Most dispensed

9,139,159 Medicaid prescriptions (Q1–Q4 2025) 83% of Fluticasone prescriptions shown $139.5M gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 19 of 302 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1797907

120 ACTUAT fluticasone propionate 0.044 MG/ACTUAT Metered Dose Inhaler

869,924 Medicaid prescriptions (Q1–Q4 2025) 8% of Fluticasone prescriptions shown $131.4M gross reimbursement (before rebates) ≈ $151 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 895994

120 ACTUAT fluticasone propionate 0.11 MG/ACTUAT Metered Dose Inhaler

719,633 Medicaid prescriptions (Q1–Q4 2025) 7% of Fluticasone prescriptions shown $143.3M gross reimbursement (before rebates) ≈ $199 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 895999

120 ACTUAT fluticasone propionate 0.22 MG/ACTUAT Metered Dose Inhaler

112,562 Medicaid prescriptions (Q1–Q4 2025) 1% of Fluticasone prescriptions shown $35.5M gross reimbursement (before rebates) ≈ $315 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896004

30 ACTUAT fluticasone furoate 0.1 MG/ACTUAT Dry Powder Inhaler

77,839 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $17M gross reimbursement (before rebates) ≈ $218 per prescription (gross)

Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1547658

fluticasone propionate 0.5 MG/ML Topical Cream

39,820 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $718,204 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 8 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 895987

30 ACTUAT fluticasone furoate 0.2 MG/ACTUAT Dry Powder Inhaler

34,016 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $10M gross reimbursement (before rebates) ≈ $294 per prescription (gross)

Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1547671

30 ACTUAT fluticasone furoate 0.05 MG/ACTUAT Dry Powder Inhaler

15,241 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $3.3M gross reimbursement (before rebates) ≈ $213 per prescription (gross)

Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2045377

fluticasone propionate 0.00005 MG/MG Topical Ointment

15,077 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $466,266 gross reimbursement (before rebates) ≈ $31 per prescription (gross)

Summed across the 6 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 895487

fluticasone propionate 0.093 MG/ACTUAT Metered Dose Nasal Spray

14,954 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $10.7M gross reimbursement (before rebates) ≈ $718 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1946583

60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT Dry Powder Inhaler

13,819 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $2.2M gross reimbursement (before rebates) ≈ $160 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896021

60 ACTUAT fluticasone propionate 0.05 MG/ACTUAT Dry Powder Inhaler

8,055 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $146 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896018

60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT Dry Powder Inhaler

7,268 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $1.6M gross reimbursement (before rebates) ≈ $220 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 896025

fluticasone propionate 0.5 MG/ML Topical Lotion

156 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $46,193 gross reimbursement (before rebates) ≈ $296 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 895990

14 ACTUAT fluticasone furoate 0.2 MG/ACTUAT Dry Powder Inhaler

31 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $4,034 gross reimbursement (before rebates) ≈ $130 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 1547666

14 ACTUAT fluticasone furoate 0.1 MG/ACTUAT Dry Powder Inhaler

29 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $2,983 gross reimbursement (before rebates) ≈ $103 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 1547663

Other Fluticasone products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

1,387 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluticasone prescriptions shown $345,625 gross reimbursement (before rebates) ≈ $249 per prescription (gross)

Summed across the 2 of 182 listed NDC products with Medicaid activity.

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 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 51 of 565 listed Fluticasone NDCs with Medicaid activity.

🔍 Compare Fluticasone products

A representative set of FDA-listed product records for Fluticasone — 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.)

Showing 200 of 505 products — FDA National Drug Code Directory. For the full list, search the NDC directory →

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) Fluticasone RxCUI 41126 6 dose forms · 20 strengths
  1. Dose form (SCDF) Dry Powder Inhaler RxCUI 746765 In current FDA listings
    Clinical drug / strength (SCD) Sensor 60 ACTUAT fluticasone propionate 0.055 MG/ACTUAT RxCUI 2395839 Sensor 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT RxCUI 2395835 Sensor 60 ACTUAT fluticasone propionate 0.232 MG/ACTUAT RxCUI 2395837 14 ACTUAT fluticasone furoate 0.1 MG/ACTUAT RxCUI 1547663 14 ACTUAT fluticasone furoate 0.2 MG/ACTUAT RxCUI 1547666 30 ACTUAT fluticasone furoate 0.05 MG/ACTUAT RxCUI 2045377 30 ACTUAT fluticasone furoate 0.1 MG/ACTUAT RxCUI 1547658 30 ACTUAT fluticasone furoate 0.2 MG/ACTUAT RxCUI 1547671 60 ACTUAT fluticasone propionate 0.05 MG/ACTUAT RxCUI 896018 60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT RxCUI 896021 60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT RxCUI 896025
  2. Dose form (SCDF) Topical Cream RxCUI 378620 In current FDA listings
    Clinical drug / strength (SCD) propionate 0.5 MG/ML RxCUI 895987
  3. Dose form (SCDF) Topical Lotion RxCUI 577392 In current FDA listings
    Clinical drug / strength (SCD) propionate 0.5 MG/ML RxCUI 895990
  4. Dose form (SCDF) Topical Ointment RxCUI 372254 In current FDA listings
    Clinical drug / strength (SCD) propionate 0.00005 MG/MG RxCUI 895487

Look up RxCUI 41126 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.

🏷️ Sold under these brand names

Arnuity Aller-Flo Clarispray Flonase Flonase Sensimist Nasopro 24 Xhance FlutiCare Beser Armonair Cutivate Flovent Allergy Relief Fluticasone Propionate Diskus Arnuity Ellipta Fluticasone Propionate HFA

🏭 Manufacturers & labelers

A-S Medication Solutions 38 GlaxoSmithKline LLC 24 Prasco Laboratories 21 Bryant Ranch Prepack 19 Apotex Corp. 14 CVS Pharmacy 11 RPK Pharmaceuticals, Inc. 10 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 10 Sportpharm LLC 10 Proficient Rx LP 9 Target Corporation 8 Preferred Pharmaceuticals Inc. 8 Padagis Israel Pharmaceuticals Ltd 8 Topco Associates LLC 8 NuCare Pharmaceuticals,Inc. 8 Allegiant Health 7 Walgreen Company 7 L. Perrigo Company 6 Rite Aid Corporation 6 Walmart 6 Walgreens 6 Teva Respiratory, LLC 6 Sterling Spa 6 Amazon.com Services LLC 6

…and 16 more on the FDA NDC directory.

RxNorm drug class

Fluticasone belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, potent (group III), Corticosteroids, Glucocorticoids
How it works Corticosteroid Hormone Receptor 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.

🔬 Where this comes from

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 Apr 9, 2019
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fluticasone.
📈
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 Fluticasone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
119
NDC products indexed
505
Distinct labelers/manufacturers represented
138
Linked representative label
Direct RX
Linked label effective
Apr 9, 2019
Composite sections available
24
Linked SPL Set ID
ab7529ac-fa19-4be8-9906-8889fa3e8398
Linked SPL Document ID
861d65c9-fb38-b548-e053-2a91aa0a2366
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 119 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Direct RX is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.