Two medicines, side by side
Acetaminophen vs phenylephrine
Acetaminophen and phenylephrine are both labeled for cough and cold. Drugs@FDA records approvals of acetaminophen since 1968 and of phenylephrine since 2012. Pharmacies paid $0.0339 per unit (Acetaminophen 500 mg caplet) and $5.24 per mL (Phenylephrine 10% eye drop) (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 phenylephrine FDA label on DailyMed (effective August 19, 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 phenylephrine record
Phenylephrine (Biorphen) · label of August 19, 2026
Used for
From the label: indicationsIMMPHENTIV injection 100 mcg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride Injection 10 mg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. […]
On the market
- Earliest approval on file
- December 20, 2012
- Generic labelers
- 33 labelers
- Pharmacy cost
- $5.24 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 90
Source: FDA drug labels via openFDA (Acetaminophen label of November 13, 2024, Phenylephrine label of August 19, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do acetaminophen and phenylephrine differ on the record?
Only the acetaminophen label carries a boxed warning.
Generics: acetaminophen since 1986; phenylephrine since 2018 (Drugs@FDA).
| Acetaminophen | Phenylephrine | |
|---|---|---|
| Labeled for | Fever, Cough and cold, Pain | Cough and cold, Allergies |
| Pharmacologic class | n/a | alpha-1 Adrenergic Agonist |
| How it works (label) | n/a | Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist. |
| Half-life (label) | n/a | 12.3 Pharmacokinetics Following an intravenous infusion of phenylephrine hydrochloride, the effective half-life was approximately 5 minutes. |
| Earliest approval on file (Drugs@FDA) | November 7, 1968 | December 20, 2012 |
| First generic approved | December 1, 1986 | April 27, 2018 |
| Generic labelers (NDC) | 89 labelers | 33 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0339 per unit (Acetaminophen 500 mg caplet) | $5.24 per mL (Phenylephrine 10% eye drop) |
| 12-month price change | +5% | n/a |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 19 | 90 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 445,075 | 3,736 |
| 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