Quick answers
- What is Olopatadine hydrochloride and mometasone furoate used for?
- The FDA-approved label (Ryaltris, Glenmark Pharmaceuticals Inc., USA, July 21, 2026) says: “RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients of age 6 years and older. RYALTRIS is a combination of olopatadine, a histamine-1 (H1)-receptor inhibitor, and mometasone furoate, a corticosteroid, indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Olopatadine hydrochloride and mometasone furoate have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Olopatadine hydrochloride and mometasone furoate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Olopatadine hydrochloride and mometasone furoate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 24, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Olopatadine hydrochloride and mometasone furoate?
- 2 companies list prescription products of Olopatadine hydrochloride and mometasone furoate in the FDA NDC Directory, including Hikma Specialty USA Inc. and Glenmark Pharmaceuticals Inc., USA.
What Olopatadine hydrochloride and mometasone furoate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients of age 6 years and older. RYALTRIS is a combination of olopatadine, a histamine-1 (H1)-receptor inhibitor, and mometasone furoate, a corticosteroid, indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older.
— FDA label: Ryaltris, Glenmark Pharmaceuticals Inc., USA, effective July 21, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Spray, metered |
|---|---|
| Route | Nasal |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Ryaltris |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| mometasone furoate monohydrate 25 ug · olopatadine hydrochloride 665 ug spray, metered | Brand: Ryaltris | $7.67 per gram |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Specialty USA Inc.1 product
- Glenmark Pharmaceuticals Inc., USA1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA211746 RYALTRIS | Glenmark Speclt | January 13, 2022 | 4, latest July 7, 2026 2026: Efficacy · 2023: Labeling · 2023: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 24, 2024 · Class II · Ongoing · D-0006-2025
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark — Glenmark Pharmaceuticals Inc., USA
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 2591806, 2591812 |
|---|---|
| SPL set ID of the quoted label | 406be932-f00e-4c66-9dd1-c142090fe822 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA211746 |
| Active ingredients (FDA) | MOMETASONE FUROATE MONOHYDRATE / OLOPATADINE HYDROCHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ryaltris, Glenmark Pharmaceuticals Inc., USA, effective July 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →