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FLONASE SENSIMIST
fluticasone furoate · Spray, Metered
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Fluticasone Furoate | 27.5 ug/1 | 1547658 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Corticosteroid Hormone Receptor Agonists [MoA] | MoA | All 215 members |
| Corticosteroid [EPC] | EPC | All 215 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 022051-002 | FLONASE SENSIMIST ALLERGY RELIEF | SPRAY, METERED | FLUTICASONE FUROATE | Over-the-counter | — | RLD RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Patents and exclusivity
Source: Orange Book| Patent | Expires | Product | Substance | Use code | Submitted |
|---|---|---|---|---|---|
| 8062264 | April 5, 2026 | 002 | No | August 31, 2016 | |
| 8347879 | July 15, 2028 | 002 | No | August 31, 2016 | |
| 8147461 | October 15, 2028 | 002 | No | August 31, 2016 |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 27 | Labeling | Approved | December 19, 2025 | Standard |
| Supplement | 25 | Labeling | Approved | September 15, 2025 | Standard |
| Supplement | 24 | Labeling | Approved | January 10, 2025 | Standard |
| Supplement | 23 | Labeling | Approved | October 24, 2024 | Standard |
| Supplement | 21 | Labeling | Approved | November 15, 2023 | Standard |
| Supplement | 17 | Labeling | Approved | August 23, 2017 | Standard |
| Supplement | 14 | Labeling | Approved | April 5, 2017 | Standard |
| Supplement | 13 | Efficacy | Approved | August 2, 2016 | Standard |
| Supplement | 11 | Labeling | Approved | May 21, 2015 | Standard |
| Supplement | 8 | Efficacy | Approved | August 21, 2012 | Standard |
| Supplement | 7 | Labeling | Approved | October 13, 2011 | Standard |
| Supplement | 5 | Labeling | Approved | September 1, 2011 | Standard |
| Supplement | 2 | Labeling | Approved | July 28, 2009 | Standard |
| Original application | 1 | Type 2 - New Active Ingredient | Approved | April 27, 2007 | Standard |
Review documents
- 0 · Supplement · December 23, 2025
- 0 · Supplement · December 23, 2025
- 0 · Supplement · September 16, 2025
- 0 · Supplement · September 16, 2025
- 0 · Supplement · January 13, 2025
- 0 · Supplement · January 13, 2025
- 0 · Supplement · October 28, 2024
- 0 · Supplement · October 28, 2024
- 0 · Supplement · November 16, 2023
- 0 · Supplement · November 16, 2023
- 0 · Supplement · May 22, 2018
- 0 · Original application · February 23, 2018
- 0 · Supplement · August 29, 2017
- 0 · Supplement · April 12, 2017
- 0 · Supplement · April 12, 2017
- 0 · Supplement · November 10, 2016
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241219). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes (for ages 12 and older)
Purpose
openFDA Drug LabelingPurpose Allergy symptom reliever
Dosage and Administration
openFDA Drug LabelingDirections • read the Quick Start Guide for how to: • shake vigorously before each use • prime the bottle • use the spray • sniff gently after each spray • clean the spray nozzle with a clean dry tissue • use this product only once a day • do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER • Week 1 – use 2 sprays in each nostril once daily • Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms • After 6 months of daily use – ask your doctor if you can keep using CHILDREN 2 TO 11 YEARS OF AGE • the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. • an adult should supervise use • use 1 spray in each nostril once daily CHILDREN UNDER 2 YEARS OF AGE • do not use
Warnings
openFDA Drug LabelingWarnings Only for use in the nose. Do not spray into your eyes or mouth. Do not use • in children under 2 years of age • to treat asthma • if you have an injury or surgery to your nose that is not fully healed • if you have ever had an allergic reaction to this product or any of the ingredients Ask a doctor before use if you have or had glaucoma or cataracts Ask a doctor or pharmacist before use if you are taking • medicine for HIV infection (such as ritonavir) • a steroid medicine for asthma, allergies or skin rash • ketoconazole pills (medicine for fungal infection) When using this product • the growth rate of some children may be slower • stinging or sneezing may occur for a few seconds right after use • do not share this bottle with anyone else as this may spread germs • remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if • you have, or come into contact with someone who has, chicken pox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection. • you get a constant whistling sound from your nose. This may be a sign of damage inside your nose. • you get an allergic reaction to this product. Seek medical help right away. • you get new changes to your vision that develop after starting this product • you have severe or frequent nosebleeds If pregnant or breast –feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do Not Use
openFDA Drug LabelingDo not use • in children under 2 years of age • to treat asthma • if you have an injury or surgery to your nose that is not fully healed • if you have ever had an allergic reaction to this product or any of the ingredients
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have or had glaucoma or cataracts
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • you have, or come into contact with someone who has, chicken pox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection. • you get a constant whistling sound from your nose. This may be a sign of damage inside your nose. • you get an allergic reaction to this product. Seek medical help right away. • you get new changes to your vision that develop after starting this product • you have severe or frequent nosebleeds
Active Ingredient
openFDA Drug LabelingActive ingredient (in each spray) Fluticasone furoate 27.5 mcg (glucocorticoid)* *read the Question & Answer Book
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Product: 50090-6075 NDC: 50090-6075-0 120 SPRAY, METERED in a BOTTLE / 1 in a PACKAGE
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: FLUTICASONE FUROATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-5967-0 | 50090-5967 | A-S Medication Solutions | 1 BOTTLE in 1 PACKAGE (50090-5967-0) / 60 SPRAY, METERED in 1 BOTTLE | April 27, 2022 |
| 50090-6075-0 | 50090-6075 | A-S Medication Solutions | 1 BOTTLE in 1 PACKAGE (50090-6075-0) / 120 SPRAY, METERED in 1 BOTTLE | September 15, 2022 |
| 0135-0615-01 | 0135-0615 | Haleon US Holdings LLC | 1 BOTTLE in 1 CARTON (0135-0615-01) / 30 SPRAY, METERED in 1 BOTTLE | February 1, 2017 |
| 0135-0615-02 | 0135-0615 | Haleon US Holdings LLC | 1 BOTTLE in 1 PACKAGE (0135-0615-02) / 60 SPRAY, METERED in 1 BOTTLE | February 1, 2017 |
| 0135-0615-03 | 0135-0615 | Haleon US Holdings LLC | 1 BOTTLE in 1 PACKAGE (0135-0615-03) / 120 SPRAY, METERED in 1 BOTTLE | February 1, 2017 |
| 0135-0615-04 | 0135-0615 | Haleon US Holdings LLC | 3 BOTTLE in 1 PACKAGE (0135-0615-04) / 120 SPRAY, METERED in 1 BOTTLE | February 1, 2017 |
| 0135-0615-05 | 0135-0615 | Haleon US Holdings LLC | 2 BOTTLE in 1 PACKAGE (0135-0615-05) / 120 SPRAY, METERED in 1 BOTTLE | July 1, 2017 |
| 0135-0615-06 | 0135-0615 | Haleon US Holdings LLC | 1 BOTTLE in 1 PACKAGE (0135-0615-06) / 72 SPRAY, METERED in 1 BOTTLE | January 22, 2019 |
| 0135-0616-01 | 0135-0616 | Haleon US Holdings LLC | 1 BOTTLE in 1 PACKAGE (0135-0616-01) / 60 SPRAY, METERED in 1 BOTTLE | July 1, 2017 |
| 0135-0616-03 | 0135-0616 | Haleon US Holdings LLC | 1 BOTTLE in 1 PACKAGE (0135-0616-03) / 72 SPRAY, METERED in 1 BOTTLE | July 1, 2021 |
| 50090-5967 | 50090-5967 | A-S Medication Solutions | — | February 1, 2017 |
| 50090-6075 | 50090-6075 | A-S Medication Solutions | — | February 1, 2017 |
| 0135-0615 | 0135-0615 | Haleon US Holdings LLC | — | February 1, 2017 |
| 0135-0616 | 0135-0616 | Haleon US Holdings LLC | — | July 1, 2017 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.