Prescription medicine
Aspirin and butalbital and caffeine First approved as Fiorinal
Aspirin and butalbital and caffeine (Fiorinal) is a prescription medicine with an FDA approval on record since 1976. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $0.948 per butalbital-aspirin-caffeine 50-325-40 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- DEA Schedule III
Check it at the source: the aspirin and butalbital and caffeine FDA label on DailyMed (effective December 2, 2024, Sandoz Inc); the NDA 17534 record on Drugs@FDA; every aspirin and butalbital and caffeine label on DailyMed.
Highlights of the record
FDA label of December 2, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageButalbital, aspirin, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Forms and strengths
- 50 mg / 325 mg / 40 mg
- 50 mg / 500 mg / 40 mg
Capsule.
On the market
- Earliest approval on file
- May 4, 1976 Fiorinal, Allergan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first February 21, 1979; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.948 per capsule Butalbital-aspirin-caffeine 50-325-40 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 162 through July 30, 2026
What is aspirin and butalbital and caffeine used for?
From the label: indications and usageButalbital, aspirin, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine capsules in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
FDA pharmacologic class: Barbiturate, Central Nervous System Stimulant, Methylxanthine, Nonsteroidal Anti-inflammatory Drug and Platelet Aggregation Inhibitor.
Source: FDA drug label (Butalbital, aspirin, and caffeine), Sandoz Inc, effective December 2, 2024 (SPL set 0e5e3842-fc6c-4a24-8e5c-522701f7c291), via openFDA; the full label on DailyMed
Is there a generic for aspirin and butalbital and caffeine (Fiorinal)?
The FDA approved the first generic aspirin and butalbital and caffeine on February 21, 1979. 11 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists aspirin and butalbital and caffeine from 5 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1976 earliest approval on file
- 1979 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for aspirin and butalbital and caffeine (Fiorinal)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.948 per Butalbital-aspirin-caffeine 50-325-40 mg capsule, down 8% from $1.04 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Butalbital-aspirin-caffeine 50-325-40 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Butalbital-aspirin-caffeine 50-325-40 mg capsule | Generic | $0.948 per capsule | $28.45 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the aspirin and butalbital and caffeine label say about other medicines?
The aspirin and butalbital and caffeine label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chlordiazepoxide | drug interactions | Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. |
| Methotrexate | drug interactions | • 6-mercaptopurine and methotrexate, causing bone marrow toxicity and blood dyscrasias by displacing these drugs from secondary binding sites, and, in the case of methotrexate, also reducing its excretion. |
| Probenecid | drug interactions | Butalbital, aspirin, and caffeine capsules may diminish the effects of: Uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout. |
Check aspirin and butalbital and caffeine against other medicines
Source: FDA drug label (Butalbital, aspirin, and caffeine), Sandoz Inc, effective December 2, 2024 (SPL set 0e5e3842-fc6c-4a24-8e5c-522701f7c291), via openFDA; the full label on DailyMed
What do FAERS reports show for aspirin and butalbital and caffeine?
The FDA Adverse Event Reporting System holds 162 reports that list aspirin and butalbital and caffeine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 42 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other barbiturates
- the pharmacologic class, with prices and generics
- Aspirin and butalbital and caffeine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other