Two medicines, side by side
Azelastine vs diphenhydramine
Azelastine and diphenhydramine are both labeled for allergies. Drugs@FDA records approvals of azelastine since 1996 and of diphenhydramine since 1946. Pharmacies paid $0.273 per mL (Azelastine 0.1% (137 mcg) spry) and $0.898 per mL (Diphenhydramine 50 mg/mL vial) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.
Check it at the source: the azelastine FDA label on DailyMed (effective December 4, 2025); the diphenhydramine FDA label on DailyMed (effective November 18, 2025).
Highlights of the azelastine record
Azelastine (Astepro) · label of December 4, 2025
Used for
From the label: indicationsUses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose
On the market
- Earliest approval on file
- November 1, 1996
- Generic labelers
- 22 labelers
- Pharmacy cost
- $0.273 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 3
Highlights of the diphenhydramine record
Diphenhydramine (Benadryl) · label of November 18, 2025
Used for
From the label: indicationsDiphenhydramine hydrochloride injection, USP is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical. […]
On the market
- Earliest approval on file
- March 4, 1946
- Generic labelers
- 20 labelers
- Pharmacy cost
- $0.898 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 8
Source: FDA drug labels via openFDA (Azelastine label of December 4, 2025, Diphenhydramine label of November 18, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do azelastine and diphenhydramine differ on the record?
Both are in FDA's class histamine-1 receptor antagonists.
Generics: azelastine since 2009; diphenhydramine since 1972 (Drugs@FDA).
| Azelastine | Diphenhydramine | |
|---|---|---|
| Labeled for | Allergies | Cough and cold, Allergies, Pain |
| Pharmacologic class | Histamine-1 Receptor Antagonist | Histamine-1 Receptor Antagonist |
| How it works (label) | n/a | n/a |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | November 1, 1996 | March 4, 1946 |
| First generic approved | April 30, 2009 | May 9, 1972 |
| Generic labelers (NDC) | 22 labelers | 20 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.273 per mL (Azelastine 0.1% (137 mcg) spry) | $0.898 per mL (Diphenhydramine 50 mg/mL vial) |
| 12-month price change | -4% | +0.8% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 18,108 | 164,832 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to azelastine
- every medicine labeled for the same conditions