Confusion has arisen about the controlled substance status of this medication. Per DEA listing, Fioricet is a DEA exempt prescription product.
There is no logical rationale for why this is exempted from controlled substance scheduling, but it has been postulated that the concentration of butalbital with the acetaminophen (and caffeine) allows this to be an analgesic combination that the DEA allows exemption to.
However peculiar it may be, Fioricet’s sister product, Fiorinal, contains the same amount of butalbital per dose, combined with aspirin (and caffeine) instead of acetaminophen (and caffeine) but it is in fact a DEA Schedule III item.
Per the FDA National Drug Code Directory, “new formulations” of fioricet are listed as DEA Schedule III:
|Labeller||NDC||DEA Schedule||form||strength (Butalbital, Acetaminophen, Caffeine)||note|
|Watson Pharma||52544-080-01||CIII||capsule||300 mg, 50 mg, 40 mg||new formulation|
|Rx Pak Division of McKesson||65084-454-10||CIII||capsule||300 mg, 50 mg, 40 mg||new formulation|
|Cardinal Health||55154-3416-1||none||tablet||325 mg, 50 mg, 40 mg||old formulation|