No, aspirin isn't the oldest FDA-approved drug.
What holds that title?
Morphine sulfate holds the distinction as the first drug approved by the FDA's predecessor, the Division of Chemistry (established 1901), in 1906 for pain relief.[1] Aspirin, approved later in 1938 as the first non-prescription drug under the new FDA labeling rules, came second.[2]
Why the confusion around aspirin?
Aspirin's fame stems from its earlier invention (1899 by Bayer) and widespread use before formal U.S. regulation. Pre-1938, many drugs like it circulated without FDA approval, but morphine's nod marks the regulatory starting line.[3]
Timeline of earliest approvals
- 1906: Morphine (first ever).
- 1938: Aspirin and sulfanilamide (first OTC and first under Federal Food, Drug, and Cosmetic Act).
- 1939: Barbiturates like phenobarbital.
Later icons like insulin (1923, grandfathered) predate but weren't formally "approved" via modern processes.[4]
How does aspirin stack up today?
Still generic, cheap (under $0.01/dose), and off-patent since the 1920s. No active exclusivities block generics.[5]
Sources
[1]: FDA History
[2]: FDA Aspirin Approval
[3]: PBS Aspirin Timeline
[4]: NIH Drug Timeline
[5]: DrugPatentWatch: Aspirin