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Allergy Relief
Fluticasone propionate · Spray, Metered
Overview
Active ingredients
Source: NDC DirectoryForms, 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 |
|---|---|---|---|---|---|---|---|
| 207957-001 | FLUTICASONE PROPIONATE | SPRAY, METERED | FLUTICASONE PROPIONATE | Over-the-counter | — | 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.
Approval history
Source: Drugs@FDA| 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 LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260420). 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 • itchy nose • runny nose • itchy, watery eyes • sneezing
Purpose
openFDA Drug LabelingPurpose Allergy symptom reliever
Dosage and Administration
openFDA Drug LabelingDirections 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
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 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 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 (1-800-222-1222).
Do Not Use
openFDA Drug LabelingDo 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 LabelingAsk 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
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 propionate (glucocorticoid)* 50 mcg *read the Question & Answer leaflet
Adverse event reports
Source: openFDA FAERSAttributed 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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 51316-172-11 | 51316-172 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BOTTLE, SPRAY in 1 CARTON (51316-172-11) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY | January 5, 2026 |
| 51316-497-08 | 51316-497 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BOTTLE, SPRAY in 1 CARTON (51316-497-08) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY | December 16, 2025 |
| 51316-497-09 | 51316-497 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BOTTLE, SPRAY in 1 CARTON (51316-497-09) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY | February 10, 2026 |
| 51316-497-10 | 51316-497 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2 BOTTLE, SPRAY in 1 CARTON (51316-497-10) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY | February 9, 2026 |
| 51316-711-01 | 51316-711 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BOTTLE, SPRAY in 1 CARTON (51316-711-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | March 24, 2026 |
| 51316-711-02 | 51316-711 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BOTTLE, SPRAY in 1 CARTON (51316-711-02) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY | March 2, 2026 |
| 51316-711-03 | 51316-711 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2 BOTTLE, SPRAY in 1 CARTON (51316-711-03) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | March 12, 2026 |
| 53943-006-01 | 53943-006 | Discount Drug Mart | 1 BOTTLE, SPRAY in 1 CARTON (53943-006-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | July 3, 2017 |
| 53943-006-02 | 53943-006 | Discount Drug Mart | 1 BOTTLE, SPRAY in 1 CARTON (53943-006-02) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY | July 3, 2017 |
| 41250-634-08 | 41250-634 | Meijer Distribution Inc | 1 BOTTLE in 1 CARTON (41250-634-08) / 72 SPRAY, METERED in 1 BOTTLE | March 23, 2021 |
| 41250-634-09 | 41250-634 | Meijer Distribution Inc | 1 BOTTLE in 1 CARTON (41250-634-09) / 144 SPRAY, METERED in 1 BOTTLE | June 28, 2021 |
| 41250-634-10 | 41250-634 | Meijer Distribution Inc | 2 BOTTLE in 1 CARTON (41250-634-10) / 144 SPRAY, METERED in 1 BOTTLE | March 23, 2021 |
| 59726-203-38 | 59726-203 | P & L Development, LLC | 1 BOTTLE, SPRAY in 1 CARTON (59726-203-38) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY | May 15, 2026 |
| 59726-203-54 | 59726-203 | P & L Development, LLC | 1 BOTTLE, SPRAY in 1 CARTON (59726-203-54) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | May 15, 2026 |
| 64525-6560-2 | 64525-6560 | Quality Home Products | 1 BOTTLE, SPRAY in 1 CARTON (64525-6560-2) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY | March 23, 2022 |
| 21130-863-08 | 21130-863 | Safeway | 1 BOTTLE, SPRAY in 1 CARTON (21130-863-08) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY | February 14, 2025 |
| 21130-863-09 | 21130-863 | Safeway | 1 BOTTLE, SPRAY in 1 CARTON (21130-863-09) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY | January 6, 2025 |
| 21130-863-10 | 21130-863 | Safeway | 2 BOTTLE, SPRAY in 1 CARTON (21130-863-10) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY | March 4, 2025 |
| 51316-172 | 51316-172 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | — | January 5, 2026 |
| 51316-497 | 51316-497 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | — | December 16, 2025 |
| 51316-711 | 51316-711 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | — | March 2, 2026 |
| 53943-006 | 53943-006 | Discount Drug Mart | — | July 3, 2017 |
| 41250-634 | 41250-634 | Meijer Distribution Inc | — | May 27, 2016 |
| 59726-203 | 59726-203 | P & L Development, LLC | — | May 15, 2026 |
| 64525-6560 | 64525-6560 | Quality Home Products | — | March 23, 2022 |
| 21130-863 | 21130-863 | Safeway | — | January 6, 2025 |
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 |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.