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allergy

mometasone furoate monohydrate · 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
allergy
Generic name
mometasone furoate monohydrate
Dosage form
Spray, Metered
Route
Nasal
Marketing category
NDA · NDA
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
4
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
Mometasone Furoate Monohydrate 50 ug/1 1797865 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Spray, Metered
Route of administration
Nasal
Presentations
8

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
215712
Application type
NDA · New Drug Application
Approval date
March 17, 2022
Sponsor
PERRIGO PHARMA INTL
Products on application
1
Submissions recorded
10
Products approved under application 215712.
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 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.

Approval history

Source: Drugs@FDA
Most recent submissions on application 215712.
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 Labeling

Reproduced 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.

HUMAN OTC DRUG · 20260603

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

Purpose Allergy symptom reliever

Dosage and Administration

openFDA Drug Labeling

Directions 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 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 • 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 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 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 Labeling

Active ingredient (in each spray) Mometasone furoate monohydrate (glucocorticoid) 50 mcg

Adverse event reports

Source: openFDA FAERS
508
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: 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
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
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

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.