Two medicines, side by side
Acetaminophen vs benzonatate
Acetaminophen and benzonatate are both labeled for cough and cold. Drugs@FDA records approvals of acetaminophen since 1968 and of benzonatate since 1958. Pharmacies paid $0.0339 per unit (Acetaminophen 500 mg caplet) and $0.0656 per benzonatate 100 mg capsule (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 benzonatate FDA label on DailyMed (effective August 3, 2026).
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 benzonatate record
Benzonatate (Tessalon) · label of August 3, 2026
Used for
From the label: indicationsBenzonatate capsules, USP are indicated for the symptomatic relief of cough.
On the market
- Earliest approval on file
- February 10, 1958
- Generic labelers
- 45 labelers
- Pharmacy cost
- $0.0656 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 7
Source: FDA drug labels via openFDA (Acetaminophen label of November 13, 2024, Benzonatate label of August 3, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do acetaminophen and benzonatate differ on the record?
Only the acetaminophen label carries a boxed warning.
Generics: acetaminophen since 1986; benzonatate since 1993 (Drugs@FDA).
| Acetaminophen | Benzonatate | |
|---|---|---|
| Labeled for | Fever, Cough and cold, Pain | Cough and cold |
| Pharmacologic class | n/a | Non-narcotic Antitussive |
| How it works (label) | n/a | n/a |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | November 7, 1968 | February 10, 1958 |
| First generic approved | December 1, 1986 | January 29, 1993 |
| Generic labelers (NDC) | 89 labelers | 45 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0339 per unit (Acetaminophen 500 mg caplet) | $0.0656 per capsule (Benzonatate 100 mg capsule) |
| 12-month price change | +5% | -8% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 19 | 7 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 445,075 | 16,446 |
| 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