Skip to the answer

Mometasone

Mometasone is a corticosteroid (anti-inflammatory steroid) used as a nasal spray for allergy symptoms and nasal polyps, as an inhaler for asthma, as a sinus implant for nasal polyps, and on the skin for inflamed, itchy skin conditions.

Brand names PropelAsmanexNasonexSinuvaMometasone Furoate +11 more
Drug class Corticosteroid Hormone Receptor Agonists
Rx/OTC Forms 5
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 37 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026 🚨Recall on record
Other forms & routes:
Mometasone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Mometasone is a strong anti-inflammatory steroid used as a nasal spray for hay fever and nasal polyps, an inhaler for daily asthma control, a sinus implant, and a cream or ointment for inflamed skin; around since about 1987 and available as a generic, it is a standard first choice for hay fever and ongoing asthma. Most people tolerate it well; headache and sore throat are the usual complaints, plus mouth thrush (a yeast infection) with the inhaler. The one rule is that the Asmanex inhaler prevents asthma symptoms but cannot stop an attack, so keep a fast-acting rescue inhaler on hand. Use the lowest dose that works, and have children's growth checked.

Clinical pearls

  • Rinse your mouth with water and spit after each Asmanex dose to cut the risk of mouth thrush.
  • Asmanex Twisthaler contains milk protein, so skip it if you have a milk protein allergy.
  • Itraconazole, ketoconazole, clarithromycin and ritonavir or cobicistat HIV regimens can raise inhaled mometasone levels and steroid side effects.
  • Prime a new nasal spray before first use, and start it before pollen season, since it works best as prevention.
How you get itPrescription and over the counter
Comes asTopical cream, ointment or gel, Nasal spray, Inhaler +2
Earliest FDA record1987
Companies listing it with the FDA26
FDA label last updatedJun 7, 2023
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Mometasone, written from its FDA label.

What Mometasone is used for

▾

Mometasone is a corticosteroid used in several forms.

  • Nasal spray: prevention of seasonal allergic rhinitis symptoms in ages 12 and older
  • Nasal spray (prescription): chronic rhinosinusitis with nasal polyps in adults 18 and older
  • Over-the-counter nasal spray: temporary relief of hay fever and upper respiratory allergy symptoms
  • Asmanex Twisthaler: maintenance treatment of asthma in ages 4 and older
  • Asmanex HFA: maintenance treatment of asthma in ages 5 and older
  • Sinuva Sinus Implant: nasal polyps in adults 18 and older after ethmoid sinus surgery
  • Cream and ointment: inflamed, itchy skin conditions in ages 2 and older
  • Lotion (topical solution): inflamed, itchy skin conditions in ages 12 and older

How Mometasone works

▾

Mometasone is a corticosteroid that calms inflammation. It dampens the activity of many immune cells and chemical signals involved in inflammation, including mast cells, eosinophils and histamine.

In lab tests it binds to the glucocorticoid receptor more strongly than several other steroids. The clinical importance of this is unknown. For asthma, benefit builds slowly, and full effect may take 1 to 2 weeks or longer.

Mometasone dosage

▾

Dosing depends on the product, so follow your prescriber and label.

  • Nasal spray is used in the nose, usually once daily for allergies, and prescription use for nasal polyps may be once or twice daily.
  • Asmanex inhalers are used regularly by mouth, followed by rinsing and spitting.
  • Sinuva is placed by an ENT doctor and can stay up to 90 days.
  • Skin products go on affected skin once daily. Stop when the condition is controlled.

Dosing details from the FDA-approved label

From the Mometasone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Sinuva: nasal polyps (ethmoid sinus implant)
    • One SINUVA Sinus Implant (1350 mcg of mometasone furoate) placed in an ethmoid sinus
    • May be left in the sinus to gradually release the corticosteroid over 90 days
    • Remove the implant by 90 days or earlier at the physician's discretion; for use by physicians trained in otolaryngology
  • Asmanex HFA: asthma in patients 12 years of age and older
    • 2 inhalations twice daily of ASMANEX HFA 100 mcg or 200 mcg
    • Starting dosage based on previous asthma therapy and disease severity
    • Not on an inhaled corticosteroid: 100 mcg, 2 inhalations twice daily
    • Currently on chronic oral corticosteroid therapy: begin with 200 mcg (2 inhalations twice daily)
    • Maximum: 2 inhalations of ASMANEX HFA 200 mcg twice daily (maximum of 800 mcg a day)
    • If not adequately responding after 2 weeks, increasing the dosage may provide additional control
  • Asmanex HFA: asthma in patients aged 5 to less than 12 years
    • 2 inhalations twice daily of ASMANEX HFA 50 mcg
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Apply a thin film of mometasone furoate cream to the affected skin areas once daily. Mometasone furoate cream may be used in pediatric patients 2 years of age or older. Since safety and efficacy of mometasone furoate cream have not been established in pediatric patients below 2 years of age; use in this age group is not recommended [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] . Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1) ] . Do not use mometasone furoate cream with occlusive dressings unless directed by a physician. Do not apply mometasone furoate cream in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing. Avoid contact with eyes. Wash hands after each application. Avoid use on the face, groin, or axillae. Mometasone furoate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use. 1. Apply a thin film to the affected skin areas once daily. ( 2 ) 2. Discontinue therapy when control is achieved. ( 2 ) 3. If no improvement is seen within 2 weeks, reassess diagnosis. ( 2 ) 4. Do not use with occlusive dressings unless directed by a physician. ( 2 )

Read the full Dosage and Administration section on DailyMed →

Mometasone side effects

▾

Common effects reported with the Asmanex Twisthaler inhaler include:

Common side effects

  • Headache
  • Allergic rhinitis, sore throat (pharyngitis) and upper respiratory infections
  • Sinusitis
  • Oral thrush (yeast infection in the mouth) with inhalers
  • Menstrual pain (dysmenorrhea)
  • Muscle and back pain
  • Indigestion

When to get medical help

  • Call your doctor if you develop white patches or soreness in your mouth or throat while using an inhaler.
  • Get help right away if wheezing suddenly gets worse right after using an inhaler (paradoxical bronchospasm).
  • Get emergency help for signs of a severe allergic reaction such as swelling, hives, rash or trouble breathing.
  • Call your doctor if asthma worsens or does not respond to your rescue inhaler.
  • Tell your doctor about vision changes or eye symptoms, which can signal glaucoma or cataracts.
  • Report extreme tiredness, weakness, nausea, vomiting or low blood pressure, which can signal adrenal problems.
  • Avoid exposure to chickenpox or measles and call your doctor if exposed.

Get help for allergic reactions, sudden wheezing after a dose, mouth or throat thrush, vision changes, or signs of adrenal problems.

Mometasone warnings and precautions

▾
  • Asmanex inhalers are not for sudden asthma symptoms. Use your rescue inhaler and call your doctor if asthma gets worse.
  • Steroids can mask or worsen infections, including tuberculosis, and chickenpox or measles can be more serious.
  • Switching from oral steroids can cause adrenal insufficiency, so taper slowly.
  • High doses or long use can cause adrenal suppression and hypercorticism.
  • Long-term use can lower bone density, slow growth in children, and cause glaucoma and cataracts.
  • Serious allergic reactions can occur.

Mometasone interactions

▾

Strong CYP3A4 inhibitors matter most, especially with the inhaler.

  • Ketoconazole, itraconazole, clarithromycin, ritonavir, atazanavir, cobicistat-containing products, indinavir, nefazodone, nelfinavir, saquinavir and telithromycin can raise mometasone levels, which may increase steroid side effects.

Interactions listed in the FDA-approved label

From the Mometasone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Short-acting beta 2-agonists and intranasal corticosteroids: In clinical trials, concurrent administration with ASMANEX HFA did not result in an increased frequency of adverse drug reactions.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin): May inhibit the metabolism of mometasone furoate and increase systemic exposure, potentially increasing the risk of systemic corticosteroid side effects; after oral ketoconazole, mean plasma concentration of inhaled mometasone furoate increased. Use with caution; consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, and monitor patients for systemic corticosteroid side effects.
Read the label’s full interactions text

7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with mometasone furoate topical solution (lotion).

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Mometasone

▾
  • Do not use Asmanex Twisthaler if you are allergic to milk proteins or its ingredients, or for a severe acute asthma episode.
  • Tell your doctor about tuberculosis, other infections, or eye herpes.
  • Tell your doctor if you recently stopped or are tapering oral steroids.
  • Children's growth should be monitored.
  • Nasal spray for polyps is not established under age 18.
  • Pregnancy and breastfeeding: discuss with your doctor. Mometasone is minimally absorbed after nasal use.
  • Liver impairment can raise mometasone levels.
  • Older adults showed no differences in safety or effectiveness with the nasal spray.

Mometasone overdose

▾

For the nasal spray, overdose is unlikely to need treatment beyond observation because very little is absorbed. Long-term excess use of any corticosteroid can cause signs of hypercorticism (too much steroid effect).

What Mometasone does in the body

▾

In studies, mometasone nasal spray at tested doses did not significantly lower cortisol compared with placebo, while prednisone did. High doses of the dry powder inhaler did affect adrenal function measures. Inhaled steroids can suppress adrenal function, particularly at higher doses.

How your body processes Mometasone

▾

After inhalation of Asmanex HFA, mometasone is absorbed with peak levels at about 0.5 to 2 hours. Swallowed mometasone has negligible systemic bioavailability. It is mainly metabolized by CYP3A4, and liver impairment can raise levels.

How to store Mometasone

▾

Store at 20° to 25°C (68° to 77°F) . Avoid excessive heat.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Mometasone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Mometasone — the kind of thing our pharmacy team would talk through with you at the counter.

What is mometasone used for?

▾
It depends on the product. The nasal spray treats hay fever symptoms and nasal polyps, Asmanex inhalers treat asthma long term, Sinuva treats nasal polyps after sinus surgery, and the skin products treat inflamed, itchy skin conditions.

Can I use my Asmanex inhaler during an asthma attack?

▾
No. Asmanex is for daily control, not quick relief. Use your fast-acting rescue inhaler, and call your doctor if your asthma isn't responding.

Why do I need to rinse my mouth after the inhaler?

▾
Inhaled steroids can cause thrush, a yeast infection in the mouth and throat. Rinse with water and spit it out, without swallowing, after every dose.

How long until it works?

▾
For asthma, full benefit may take 1 to 2 weeks or longer, so keep using it as directed. For skin products, call your doctor if there's no improvement in 2 weeks.

Are there any medicines I should watch out for?

▾
Yes. Strong CYP3A4 inhibitors like ketoconazole, itraconazole, clarithromycin and ritonavir can raise mometasone levels. Tell me or your doctor about everything you take.

Is it safe for kids?

▾
Age limits depend on the product. Steroid nasal sprays and inhalers can slow growth in some children, so your child's doctor should monitor growth and use the lowest effective dose.

Is Mometasone available over the counter?

▾
Both. Some Mometasone products are sold over the counter and others need a prescription. According to their FDA listings, the nasal spray form is sold both ways, at different strengths or package sizes and the topical cream, ointment or gel, inhaler, topical solution and insert or device forms need a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Mometasone first available?

▾
The earliest FDA record we hold for Mometasone is from 1987: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Mometasone was first used.

Who makes Mometasone?

▾
26 companies currently list Mometasone products in the FDA's NDC Directory, including Bryant Ranch Prepack, Organon LLC, Padagis Israel Pharmaceuticals Ltd. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Mometasone on HelloPharmacist

Detailed data & references for Mometasone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Mometasone forms and strengths (how it comes)

Mometasone is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Mometasone inactive ingredients by manufacturer.

Topical cream, ointment or gel

On the skin
Brands Mometasone Furoate
How this form is used
What it may be used for
  • Mometasone Furoate cream and ointment relieve inflammation and itching from corticosteroid-responsive skin conditions in ages 2 and older.
Important instructions
  • Mometasone Furoate cream and ointment are applied as a thin film once daily.
  • Do not use Mometasone Furoate cream or ointment with tight dressings unless a physician directs it.
  • Avoid the face, groin and underarms, and keep it out of the eyes.
  • Stop when control is achieved, and reassess if no improvement in 2 weeks.
Available strengths 3 strengths
55 FDA-listed product records ⓘ

Nasal spray

In the nose
Brands Allergy Allergy Nasal Allergy Relief Basic Care Allergy Childrens Nasonex Leader Allergy Nasal Leader Nasal Mometasone Furoate Mometasone Furoate Monohydrate Nasonex Rugby mometasone furoate nasal Topcare Allergy
How this form is used
What it may be used for
  • Mometasone nasal spray is used to prevent seasonal allergic rhinitis symptoms in ages 12 and older, and for nasal polyps in adults 18 and older.
  • Over-the-counter allergy nasal sprays, including Leader Allergy Nasal, relieve nasal congestion, runny nose, sneezing and itchy nose from hay fever or other upper respiratory allergies.
Important instructions
  • Childrens Nasonex is used once daily and should be shaken well before each use.
  • Childrens Nasonex: children under 2 should not use it, and an adult should supervise children 2 to 11.
  • Talk to your child's doctor if Childrens Nasonex is needed for longer than two months a year.
Available strengths 1 strength
31 FDA-listed product records ⓘ

Inhaler

Inhaled
Brands Asmanex Asmanex Hfa
How this form is used
What it may be used for
  • Asmanex Twisthaler is used for maintenance treatment of asthma in ages 4 and older.
  • Asmanex HFA is used for maintenance treatment of asthma in ages 5 and older.
  • Neither Asmanex product is for relief of sudden bronchospasm.
Important instructions
  • Asmanex Twisthaler and Asmanex HFA are for oral inhalation only.
  • With Asmanex Twisthaler, inhale rapidly and deeply.
  • With Asmanex HFA, prime before first use with test sprays away from the face.
  • After Asmanex use, rinse your mouth with water and spit without swallowing.
Available strengths 6 strengths
24 FDA-listed product records ⓘ

Topical solution

On the skin
Brands Mometasone Furoate
How this form is used
What it may be used for
  • Mometasone Furoate topical solution (lotion) relieves inflammation and itching from corticosteroid-responsive skin conditions in ages 12 and older.
Important instructions
  • Mometasone Furoate lotion: apply a few drops once daily and massage lightly until it disappears.
  • Mometasone Furoate lotion is for the skin only, not for the mouth, eyes or vagina.
  • Avoid the face, groin and underarms, and do not use in the diaper area.
  • Wash your hands after each application.
Available strengths 1 strength
9 FDA-listed product records ⓘ

Insert or device

By mouth · Intrasinal
Brands Sinuva
How this form is used
What it may be used for
  • Sinuva Sinus Implant treats chronic rhinosinusitis with nasal polyps in adults 18 and older who have had ethmoid sinus surgery.
Important instructions
  • Sinuva is placed in the ethmoid sinus by a physician trained in otolaryngology.
  • Sinuva can stay in place up to 90 days, releasing medicine gradually.
  • Sinuva is removed by 90 days or sooner at the physician's discretion.
Available strengths 1 strength
3 FDA-listed product records ⓘ

Mometasone on the U.S. market: products, makers and brands

How Mometasone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

26 companies list 54 Mometasone product records with the FDA, mostly as topical cream, ointment or gel, nasal spray, inhaler; the earliest marketing or approval year on record is 1987. Brand names on the directory include Propel, Asmanex, Nasonex and 13 more; the rest are generics.

5
Dose forms ⓘ
26
Labelers (makers, repackagers, distributors)
15
Brand names
54
FDA-listed product records ⓘ
1987
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (39) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack22%
Organon LLC9%
Padagis Israel Pharmaceuticals Ltd6%
Preferred Pharmaceuticals Inc.6%
Proficient Rx LP6%
A-S Medication Solutions4%
Other makers48%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Mometasone is used (Medicaid data)

A general measure of how commonly Mometasone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Mometasone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

666,398
Medicaid prescriptions filled (Q1–Q4 2025)
$25M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Mometasone prescribed? Of the 1,601 medications we measure, Mometasone ranks #225 by Medicaid prescriptions — more than 86% of them.

Where Mometasone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Mometasone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mg/mL topical cream is the most-dispensed Mometasone product — about 32% of these Medicaid prescriptions.

mometasone furoate 1 MG/ML Topical Cream Most dispensed

212,025 Medicaid prescriptions (Q1–Q4 2025) 32% of Mometasone prescriptions shown $4.1M gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 4 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311753

mometasone furoate 0.001 MG/MG Topical Ointment

204,546 Medicaid prescriptions (Q1–Q4 2025) 31% of Mometasone prescriptions shown $3.7M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 4 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 151029

mometasone furoate 1 MG/ML Topical Lotion

77,800 Medicaid prescriptions (Q1–Q4 2025) 12% of Mometasone prescriptions shown $2M gross reimbursement (before rebates) ≈ $25 per prescription (gross)

Summed across the 4 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 151030

mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal Spray

51,854 Medicaid prescriptions (Q1–Q4 2025) 8% of Mometasone prescriptions shown $2.1M gross reimbursement (before rebates) ≈ $41 per prescription (gross)

Summed across the 8 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1797865

Other Mometasone products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

120,173 Medicaid prescriptions (Q1–Q4 2025) 18% of Mometasone prescriptions shown $13.1M gross reimbursement (before rebates) ≈ $109 per prescription (gross)

Summed across the 8 of 96 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Mometasone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 28 of 200 listed Mometasone NDCs with Medicaid activity.

Compare Mometasone products

A representative set of FDA-listed product records for Mometasone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 54 of 54 products — FDA National Drug Code Directory. See every product, package size and price: browse all 54 Mometasone NDCs →

Mometasone side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Mometasone — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Mometasone are product quality issue, dyspnoea, asthma; about 48% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

58,483
Reports mentioning it
48%
Reported as serious
12
Distinct effects shown
Most reported effects
Product Quality Issue
7,566
Dyspnoea
5,673
Asthma
3,654
Cough
3,600
Headache
3,498
Poor Quality Device Used
3,263
Fatigue
3,239
Nausea
2,811
Pain
2,312
Wheezing
2,307
Age groups
Adult · 4,580Elderly · 2,440Child · 379Adolescent · 349Neonate · 30Infant · 17

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Mometasone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Mometasone FDA approval history

How Mometasone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Mometasone was first approved by the FDA in 1987 (Brand: ELOCON · Organon); the first generic version was approved in 2002. It remains available in U.S. pharmacies today.

1987
Brand approved
Brand: ELOCON · Organon
2002
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Mometasone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 4 Mometasone recalls since July 2021, covering 5 product listings. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III May 28, 2024 · Organon Llc
Defective Container
  • Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-… Lots: Lot #: X024051, Exp 04/25/2025 FDA record D-0551-2024 →
  • Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-… Lots: Lot #: X025346, Exp 3/3/2025 FDA record D-0550-2024 →
Class III Jan 4, 2023 · Terminated · Intersect ENT, Inc.
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
  • SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01. Lots: Lot #s: 10111003, Exp 12/31/2022; 10203002, Exp 01/31/2023; 10302002, 10325001, Exp 02/28/2023; 10519001, 10526002, Exp 04/30/2023; 10602002, Exp 05/31/2023; 10819004, Exp 09/30/2023; 21092101, 21111901, Exp 10/31/2023; 21110402, Exp 12/31… FDA record D-0167-2023 →
Class III Jun 16, 2022 · Terminated · Glenmark Pharmaceuticals Inc., USA
Defective Container
  • Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himac… Lots: Lot # a) 05201358, Exp 06/2022; 05210287, 05210288, Exp 01/2023; 05211446, Exp 07/2023; 05211704, 05211714, Exp 08/2023; 05212217, Exp 10/2023: b) 05201358, Exp 06/2022; 05210287, 05210288, 05210424, Exp 01/2023; 05210425, 05210435, Exp 02… FDA record D-1173-2022 →
Class II Jan 26, 2022 · Terminated · CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
  • Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manu… Lots: Batch U027458 FDA record D-0169-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Mometasone RxCUI 108118 7 dose forms · 14 strengths
  1. Dose form (SCDF) Drug Implant RxCUI 1148518 In current FDA listings
    Clinical drug / strength (SCD) furoate 0.37 MG RxCUI 1148519 furoate 1.35 MG RxCUI 1995983
  2. Dose form (SCDF) Dry Powder Inhaler RxCUI 746792 No current FDA listing
    Clinical drug / strength (SCD) 14 ACTUAT mometasone furoate 0.22 MG/ACTUAT RxCUI 746810 30 ACTUAT mometasone furoate 0.11 MG/ACTUAT RxCUI 790283 30 ACTUAT mometasone furoate 0.22 MG/ACTUAT RxCUI 746812 60 ACTUAT mometasone furoate 0.22 MG/ACTUAT RxCUI 746814 120 ACTUAT mometasone furoate 0.22 MG/ACTUAT RxCUI 746803
  3. Dose form (SCDF) Metered Dose Inhaler RxCUI 1536141 In current FDA listings
    Clinical drug / strength (SCD) 120 ACTUAT mometasone furoate 0.05 MG/ACTUAT RxCUI 2196790 120 ACTUAT mometasone furoate 0.1 MG/ACTUAT RxCUI 1536142 120 ACTUAT mometasone furoate 0.2 MG/ACTUAT RxCUI 1536147
  4. Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797864 In current FDA listings
    Clinical drug / strength (SCD) furoate 0.05 MG/ACTUAT RxCUI 1797865
  5. Dose form (SCDF) Topical Cream RxCUI 619083 In current FDA listings
    Clinical drug / strength (SCD) furoate 1 MG/ML RxCUI 311753
  6. Dose form (SCDF) Topical Lotion RxCUI 619119 In current FDA listings
    Clinical drug / strength (SCD) furoate 1 MG/ML RxCUI 151030
  7. Dose form (SCDF) Topical Ointment RxCUI 619042 In current FDA listings
    Clinical drug / strength (SCD) furoate 0.001 MG/MG RxCUI 151029

Look up RxCUI 108118 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Mometasone costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Cream · Topical 1 mg/g $0.287–$0.420 per gram NDC details & price history
Ointment · Topical 1 mg/g $0.208–$0.292 per gram NDC details & price history
Ointment · Topical 1 mg $0.208–$0.292 per gram NDC details & price history
Spray, Metered · Nasal 50 mcg $1.19–$1.27 per mL NDC details & price history
Aerosol · Respiratory (inhalation) 50 mcg $6.84 per gram NDC details & price history
Aerosol · Respiratory (inhalation) 100 mcg $7.38 per gram NDC details & price history
Aerosol · Respiratory (inhalation) 200 mcg $8.67 per gram NDC details & price history
Solution · Topical 1 mg/mL $0.478–$0.488 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Mometasone brand names

Mometasone is sold under 16 brand names in the FDA directory — Propel, Asmanex, Nasonex, Sinuva and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Propel Asmanex Nasonex Sinuva Mometasone Furoate Asmanex Hfa Allergy topcare allergy Childrens Nasonex allergy nasal Rugby mometasone furoate nasal Allergy Relief Mometasone Furoate Monohydrate Leader Nasal Leader Allergy Nasal basic care allergy

Who makes Mometasone: manufacturers and labelers

26 companies list Mometasone products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Organon LLC, Padagis Israel Pharmaceuticals Ltd. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 12 Organon LLC 5 Padagis Israel Pharmaceuticals Ltd 3 Preferred Pharmaceuticals Inc. 3 Proficient Rx LP 3 A-S Medication Solutions 2 Amazon.com Services LLC 2 Cvs Woonsocket Prescription Center, Incorporated 2 Cosette Pharmaceuticals, Inc. 2 Encube Ethicals, Inc. 2 Glenmark Pharmaceuticals Inc., USA 2 L. Perrigo Company 2 Apotex Corp. 1 Aurobindo Pharma Limited 1 Aurohealth LLC 1 Cardinal Health 110, LLC. dba Leader 1 Golden State Medical Supply, Inc. 1 HyVee Inc 1 Intersect ENT, Inc. 1 Rite Aid Corporation 1 Rugby Laboratories 1 Sportpharm LLC 1 Sun Pharmaceutical Industries, Inc. 1 Topco Associates LLC 1

…and 2 more on the FDA NDC directory.

Mometasone drug class (RxNorm)

Mometasone belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, potent (group III), Corticosteroids, Glucocorticoids
How it works Corticosteroid Hormone Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Mometasone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 7, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Mometasone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Mometasone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
37
Finished products in the current FDA directory
54
Companies listing them (makers, repackagers, distributors)
26
FDA labeler codes behind them ⓘ
29
Linked representative label ⓘ
RPK Pharmaceuticals, Inc.
Linked label effective
Jun 7, 2023
Composite sections available
23
Linked SPL Set ID
015a259c-a0cb-4440-b8f2-0a31aa76fb88
Linked SPL Document ID
401dc847-735d-4d83-ab20-28a28abd429e
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. RPK Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →