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Prescription medicine

Ciclesonide

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Ciclesonide used for?
The FDA-approved label (Omnaris, Covis Pharma US, Inc, November 8, 2022) says: “OMNARIS Nasal Spray is a corticosteroid indicated for treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and perennial allergic rhinitis in adults and adolescents 12 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 Ciclesonide 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 Ciclesonide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ciclesonide been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Ciclesonide?
1 company lists prescription products of Ciclesonide in the FDA NDC Directory, including Covis Pharma US, Inc.

What Ciclesonide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

OMNARIS Nasal Spray is a corticosteroid indicated for treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and perennial allergic rhinitis in adults and adolescents 12 years of age and older. …

— FDA label: Omnaris, Covis Pharma US, Inc, effective November 8, 2022. 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 formsAerosol, metered · Spray
RouteRespiratory (inhalation) · Nasal
Prescription products3 in the FDA NDC Directory
Brand namesAlvesco, Omnaris

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.

NADAC per unit for Ciclesonide, by strength and form
Strength and formGeneric or brandPharmacies pay
ciclesonide 160 ug
aerosol, metered
Brand: Alvesco $42.97 per gram
ciclesonide 50 ug
spray
Brand: Omnaris $22.54 per gram
ciclesonide 80 ug
aerosol, metered
Brand: Alvesco $42.93 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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA021658
ALVESCO
AzurityJanuary 10, 2008 7, latest February 16, 2023
2023: Labeling · 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC)
NDA022004
OMNARIS
AzurityOctober 20, 2006 7, latest May 8, 2019
2019: Labeling · 2016: Labeling · 2013: Manufacturing (CMC)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)799034, 799037, 799038, 799040, 1797841, 1797843
SPL set ID of the quoted label15fefd46-ac7e-40d0-b635-e6c3d653c666
FDA labels (SPL)2
FDA applicationsNDA021658, NDA022004
Active ingredients (FDA)CICLESONIDE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Omnaris, Covis Pharma US, Inc, effective November 8, 2022; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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