Two medicines, side by side
Acetaminophen vs azelastine
Acetaminophen is labeled for fever, cough and cold and pain; azelastine for allergies. Their labels share no use, so they are not alternatives to each other. Drugs@FDA records approvals of acetaminophen since 1968 and of azelastine since 1996. Pharmacies paid $0.0339 per unit (Acetaminophen 500 mg caplet) and $0.273 per mL (Azelastine 0.1% (137 mcg) spry) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Only the acetaminophen label carries a boxed warning.
Check it at the source: the acetaminophen FDA label on DailyMed (effective November 13, 2024); the azelastine FDA label on DailyMed (effective December 4, 2025).
Highlights of the acetaminophen record
Acetaminophen (Tylenol) · label of November 13, 2024
Used for
From the label: indicationstemporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever
On the market
- Earliest approval on file
- November 7, 1968
- Generic labelers
- 89 labelers
- Pharmacy cost
- $0.0339 per unit
Supply and safety
- Shortage
- No current entry
- Recalls
- 19
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
Source: FDA drug labels via openFDA (Acetaminophen label of November 13, 2024, Azelastine label of December 4, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do acetaminophen and azelastine differ on the record?
Only the acetaminophen label carries a boxed warning.
Generics: acetaminophen since 1986; azelastine since 2009 (Drugs@FDA).
| Acetaminophen | Azelastine | |
|---|---|---|
| Labeled for | Fever, Cough and cold, Pain | Allergies |
| Pharmacologic class | n/a | 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 7, 1968 | November 1, 1996 |
| First generic approved | December 1, 1986 | April 30, 2009 |
| Generic labelers (NDC) | 89 labelers | 22 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0339 per unit (Acetaminophen 500 mg caplet) | $0.273 per mL (Azelastine 0.1% (137 mcg) spry) |
| 12-month price change | +5% | -4% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 19 | 3 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 445,075 | 18,108 |
| 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 acetaminophen
- every medicine labeled for the same conditions