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FLONASE SENSIMIST

fluticasone furoate · Spray, Metered

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
FLONASE SENSIMIST ALLERGY RELIEF
Generic name
fluticasone furoate
Dosage form
Spray, Metered
Route
Nasal
Marketing category
NDA · NDA
Labeler
A-S Medication Solutions
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
10
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Fluticasone Furoate 27.5 ug/1 1547658 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Spray, Metered
Route of administration
Nasal
Presentations
14

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Corticosteroid Hormone Receptor Agonists [MoA] MoA All 215 members
Corticosteroid [EPC] EPC All 215 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
022051
Application type
NDA · New Drug Application
Approval date
April 27, 2007
Sponsor
HALEON US HOLDINGS
Products on application
1
Submissions recorded
14
Products approved under application 022051.
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 Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes 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 listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
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
Most recent submissions on application 022051.
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 Labeling

Reproduced 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.

HUMAN OTC DRUG · 20241219 HUMAN OTC DRUG · 20240305 HUMAN OTC DRUG · 20231117

Indications and Usage

openFDA Drug Labeling

Uses 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 Allergy symptom reliever

Dosage and Administration

openFDA Drug Labeling

Directions • 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 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 • 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 Labeling

Ask a doctor before use if you have or had glaucoma or cataracts

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

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each spray) Fluticasone furoate 27.5 mcg (glucocorticoid)* *read the Question & Answer Book

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-6075 NDC: 50090-6075-0 120 SPRAY, METERED in a BOTTLE / 1 in a PACKAGE

Adverse event reports

Source: openFDA FAERS
87,085
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.