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allergy nasal

Fluticasone propionate · Spray, Metered

Over-the-counter ANDA 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
allergy nasal
Generic name
Fluticasone propionate
Dosage form
Spray, Metered
Route
Nasal
Marketing category
ANDA · ANDA
Labeler
Walgreen Company
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
4
Packages
12
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 Propionate 50 ug/1 1797907 View
Mometasone Furoate Monohydrate 50 ug/1 1797865 View
Triamcinolone Acetonide 55 ug/1 1014314 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Spray, Metered
Route of administration
Nasal
Presentations
16

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
207957
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 26, 2016
Sponsor
HIKMA
Products on application
1
Submissions recorded
4
Products approved under application 207957.
Product Trade name Form Strength Ingredient Status TE Flags
207957-001 FLUTICASONE PROPIONATE SPRAY, METERED FLUTICASONE PROPIONATE Over-the-counter — RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
No
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.

Approval history

Source: Drugs@FDA
Most recent submissions on application 207957.
Type No. Action Status Date Review
Supplement 4 Labeling Approved November 27, 2019 Standard
Supplement 2 Manufacturing (CMC) Approved December 29, 2016 Unknown
Supplement 1 Manufacturing (CMC) Approved August 2, 2016 Unknown
Original application 1 Approved May 26, 2016 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260407). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260407 HUMAN OTC DRUG · 20260306 HUMAN OTC DRUG · 20241218

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

Purpose Allergy symptom reliever

Dosage and Administration

openFDA Drug Labeling

Directions Read insert (inside package) on how to: • get a new bottle ready (primed) before first use • prime bottle again if not used for more than 2 weeks • use the spray • clean the spray nozzle ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER adults and children 12 years of age and older • once daily, spray 2 times into each nostril while sniffing gently • once your allergy symptoms improve, reduce to 1 spray in each nostril per day CHILDREN 2 TO UNDER 12 YEARS OF AGE • the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. children 6 to under 12 years of age • an adult should supervise use • once daily, spray 1 time into each nostril while sniffing gently • if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day. children 2 to under 6 years of age • an adult should supervise use • once daily, spray 1 time into each nostril while sniffing gently children under 2 years of age • do not use • do not use more than directed • if you forget a dose, do not double the next dose • do not spray into eyes or mouth • if allergy symptoms do not improve after one week, stop using and talk to a doctor • do not use for the common cold • shake well before each 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 an eye infection • 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 may occur for a few seconds right after use • you may start to feel relief within 12 hours and full effect after several days of regular, once-a-day 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 chickenpox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get a new symptom 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 (1-800-222-1222).

Do not use • in children under 4 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 had recent nose ulcers or nose surgery • have had a nose injury that has not healed • are using a steroid medicine for asthma, allergies or skin rash • have an eye infection • 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) Mometasone furoate monohydrate (glucocorticoid) 50 mcg

Adverse event reports

Source: openFDA FAERS
224,191
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 PROPIONATE. 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
51316-181-08 51316-181 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE, SPRAY in 1 CARTON (51316-181-08) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY May 30, 2024
51316-181-09 51316-181 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE, SPRAY in 1 CARTON (51316-181-09) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY May 30, 2024
51316-181-10 51316-181 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 2 BOTTLE, SPRAY in 1 CARTON (51316-181-10) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY December 18, 2024
51316-181-12 51316-181 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 4 BOTTLE, SPRAY in 1 CARTON (51316-181-12) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY December 11, 2024
11822-0901-3 11822-0901 Rite Aid Corporation 1 BOTTLE, SPRAY in 1 CARTON (11822-0901-3) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY March 18, 2021
11822-0901-4 11822-0901 Rite Aid Corporation 1 BOTTLE, SPRAY in 1 CARTON (11822-0901-4) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY March 18, 2021
11822-0901-5 11822-0901 Rite Aid Corporation 2 BOTTLE, SPRAY in 1 CARTON (11822-0901-5) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY May 28, 2021
11822-0901-6 11822-0901 Rite Aid Corporation 3 BOTTLE, SPRAY in 1 CARTON (11822-0901-6) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY August 16, 2024
0363-0811-01 0363-0811 Walgreen Company 1 BOTTLE in 1 CARTON (0363-0811-01) / 120 SPRAY, METERED in 1 BOTTLE April 10, 2016
0363-0811-02 0363-0811 Walgreen Company 1 BOTTLE in 1 CARTON (0363-0811-02) / 60 SPRAY, METERED in 1 BOTTLE August 2, 2017
0363-0811-03 0363-0811 Walgreen Company 2 BOTTLE in 1 CARTON (0363-0811-03) / 120 SPRAY, METERED in 1 BOTTLE November 3, 2016
0363-2060-02 0363-2060 Walgreen Company 1 BOTTLE, SPRAY in 1 PACKAGE (0363-2060-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY March 30, 2023
51316-181 51316-181 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED — May 30, 2024
11822-0901 11822-0901 Rite Aid Corporation — November 19, 2020
0363-0811 0363-0811 Walgreen Company — April 10, 2016
0363-2060 0363-2060 Walgreen Company — March 30, 2023

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
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.