Quick answers
- What is Azelastine used for?
- The Drug Facts label of Azelastine Hydrochloride (Aurohealth LLC) lists these uses: temporarily relieves these symptoms due to hay fever or other upper respiratory allergies; nasal congestion; runny nose; sneezing; itchy nose.
- Do I need a prescription for Azelastine?
- No, the products on this page are sold without a prescription. Other products with the same active ingredient need a prescription (often a higher strength or another form): see the prescription page.
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredient, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Azelastine been recalled?
- No recall linked to these products appears in the FDA enforcement reports we use.
Also sold by prescription (often at a higher strength or in another form): Azelastine hydrochloride — prescription medicine
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
Azelastine Hydrochloride · Aurohealth LLC
Azelastine hydrochloride 205.5 ug, spray, metered (nasal)
Active ingredient
Drug Facts Active ingredient (in each spray) Azelastine hydrochloride USP 205.5 mcg (equivalent to 187.6 mcg azelastine)
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- nasal congestion
- runny nose
- sneezing
- itchy nose
Warnings
Only for use in the nose. Do not spray in eyes or mouth.
Do not use
if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
you
- have had recent nose ulcers or nose surgery
- have had a nose injury that has not healed
When using this product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- you may get a bitter taste in your mouth. To help avoid this, tilt your head downward while spraying.
- nasal discomfort or sneezing may occur right after use
- do not share this bottle with anyone else as this may spread germs
Stop use and ask a doctor if
- an allergic reaction, such as a skin rash, to this product occurs
- 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 (1-800-222-1222) right away.
Directions
Read the User Guide for how to:
- prime the bottle before first use
- use the spray
- prime bottle again if not used for 3 or more days
- clean the spray nozzle if it gets clogged
| adults and children 12 years and older | This product may be used either once or twice a day: ■ once daily: use 2 sprays in each nostril; OR ■ twice daily: use 1 or 2 sprays in each nostril every 12 hours ■ do not use more than 4 sprays in each nostril in a 24 hour period |
| children 6 years to 11 years | ■ an adult should supervise use ■ 1 spray in each nostril every 12 hours ■ do not use more than 2 sprays in each nostril in a 24 hour period |
| children under 6 years | do not use |
Inactive ingredients
benzalkonium chloride, edetate disodium, hypromellose, purified water, sodium citrate (dihydrate), sorbitol and sucralose. Questions or comments? 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016
— FDA label of Azelastine Hydrochloride, Aurohealth LLC, effective August 20, 2026. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredient, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Azelastine hydrochloride 205.5 ug · spray, metered (nasal) · 9 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Astepro Allergy | Bayer HealthCare LLC. | DailyMed |
| Children Astepro Allergy | Bayer HealthCare LLC. | DailyMed |
| Azelastine HCl | Amneal Pharmaceuticals NY LLC | DailyMed |
| Azelastine Hydrochloride | Allegiant Health | DailyMed |
| Azelastine Hydrochloride | Aurohealth LLC | DailyMed |
| Azelastine Hydrochloride | Cvs Pharmacy, Inc | — |
| Azelastine Hydrochloride | Walgreens | DailyMed |
| Azelastine Hydrochloride | YYBA Corp | DailyMed |
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Bayer HealthCare LLC.2 products
- Allegiant Health2 products
- Aurohealth LLC1 product
- Cvs Pharmacy, Inc1 product
- Amneal Pharmaceuticals NY LLC1 product
- Walgreens1 product
- YYBA Corp1 product
Recalls
No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), 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
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.