On this page
allergy
mometasone furoate monohydrate · Spray, Metered
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Mometasone Furoate Monohydrate | 50 ug/1 | 1797865 | 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 |
|---|---|---|---|---|---|---|---|
| 215712-001 | NASONEX 24HR ALLERGY | SPRAY, METERED | MOMETASONE 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.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 17 | Manufacturing (CMC) | Approved | June 7, 2024 | N/A |
| Supplement | 15 | Labeling | Approved | May 24, 2023 | Standard |
| Supplement | 12 | Labeling | Approved | March 9, 2023 | Standard |
| Supplement | 8 | Labeling | Approved | September 20, 2022 | Standard |
| Supplement | 7 | Labeling | Approved | September 20, 2022 | Standard |
| Supplement | 11 | Labeling | Tentative approval | September 19, 2022 | Standard |
| Supplement | 5 | Manufacturing (CMC) | Approved | September 16, 2022 | N/A |
| Supplement | 6 | Manufacturing (CMC) | Approved | July 15, 2022 | N/A |
| Supplement | 4 | Manufacturing (CMC) | Approved | July 15, 2022 | N/A |
| Original application | 1 | Type 8 - Partial Rx to OTC Switch | Approved | March 17, 2022 | Standard |
Review documents
- 0 · Supplement · July 2, 2024
- 0 · Supplement · July 1, 2024
- 0 · Supplement · May 25, 2023
- 0 · Supplement · May 25, 2023
- 0 · Supplement · March 10, 2023
- 0 · Supplement · March 10, 2023
- 0 · Supplement · January 31, 2023
- 0 · Supplement · January 30, 2023
- 0 · Supplement · September 21, 2022
- 0 · Supplement · September 21, 2022
- 0 · Supplement · September 21, 2022
- 0 · Supplement · September 21, 2022
- 0 · Supplement · September 21, 2022
- 0 · Supplement · September 19, 2022
- 0 · Original application · September 9, 2022
- 0 · Supplement · July 19, 2022
- 0 · Supplement · July 19, 2022
- 0 · Supplement · July 18, 2022
- 0 · Supplement · July 18, 2022
- 0 · Original application · March 18, 2022
- 0 · Original application · March 18, 2022
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260603). 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
Purpose
openFDA Drug LabelingPurpose Allergy symptom reliever
Dosage and Administration
openFDA Drug LabelingDirections Read insert (inside package) for how to: • prime the bottle • use the spray • clean the nozzle • shake well before each use • use this product only once a day • do not use more than directed Adults & children 12 years of age and older • 2 sprays in each nostril once daily while sniffing gently 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 • 1 spray in each nostril once daily while sniffing gently 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 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 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 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 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
Active Ingredient
openFDA Drug LabelingActive ingredient (in each spray) Mometasone furoate monohydrate (glucocorticoid) 50 mcg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: MOMETASONE FUROATE MONOHYDRATE. 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 |
|---|---|---|---|---|
| 72288-506-02 | 72288-506 | Amazon.com Services LLC | 1 BOTTLE, SPRAY in 1 CARTON (72288-506-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (72288-506-00) | August 27, 2026 |
| 51316-117-11 | 51316-117 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BOTTLE, SPRAY in 1 PACKAGE (51316-117-11) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY | December 22, 2023 |
| 42507-182-02 | 42507-182 | HyVee Inc | 1 BOTTLE, SPRAY in 1 CARTON (42507-182-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (42507-182-00) | January 28, 2026 |
| 11822-7099-1 | 11822-7099 | Rite Aid Corporation | 1 BOTTLE, SPRAY in 1 PACKAGE (11822-7099-1) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY | March 15, 2024 |
| 72288-506 | 72288-506 | Amazon.com Services LLC | — | August 27, 2026 |
| 51316-117 | 51316-117 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | — | December 22, 2023 |
| 42507-182 | 42507-182 | HyVee Inc | — | January 28, 2026 |
| 11822-7099 | 11822-7099 | Rite Aid Corporation | — | March 6, 2024 |
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 · 11 sections on this page.