Quick answers
- What is Dymista?
- Dymista is a brand name of Azelastine hydrochloride and fluticasone propionate, a prescription medicine. The FDA NDC Directory lists 1 Dymista product in 1 strength and form.
- Who makes Dymista?
- Mylan Speciality LP holds the FDA application for Dymista (NDA202236, approved May 1, 2012).
- Is there a generic or store brand of Dymista?
- Yes. The FDA NDC Directory lists 6 other products with the same active ingredients, strength and form as a Dymista product, 6 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Dymista?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Dymista strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Dymista been recalled?
- FDA enforcement reports list 2 recalls of Dymista products; the newest started February 1, 2019. A recall usually concerns specific lots, not every product.
What Dymista is
Each Dymista product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Azelastine hydrochloride and fluticasone propionate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| azelastine hydrochloride 137 ug · fluticasone propionate 50 ug spray, metered (nasal) | Dymista | 6 products, 5 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Azelastine hydrochloride and fluticasone propionate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA202236 | Mylan Speciality LP | May 1, 2012 | 1 |
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 |
|---|---|---|
| azelastine hydrochloride 137 ug · fluticasone propionate 50 ug spray, metered | Brand: Dymista | $9.10 per gram Generic of the same strength and form: $2.07 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 Dymista
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Dymista products.
- Viatris Specialty LLC1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 1, 2019 · Class II · Terminated · D-0424-2019
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: M — Mylan Pharmaceuticals Inc.
-
July 25, 2018 · Class II · Terminated · D-1075-2018
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23 — Mylan Pharmaceuticals Inc.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.