Active substances
Acetylsalicylic acid + Butalbital + Caffeine + Codeine
- US FDA 6
- Health Canada 6
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | capsule · oral | STEVENS J | Prescription | 31 Aug 1998 |
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | capsule · oral | LGM PHARMA | Prescription | 30 Nov 2001 |
| FIORINAL W/CODEINE | 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule · oral | ALLERGAN | Discontinued | 26 Oct 1990 |
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | capsule · oral | WATSON LABS | Discontinued | 31 Aug 1995 |
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | capsule · oral | NOVITIUM PHARMA | Discontinued | 5 Mar 1999 |
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | capsule · oral | DR REDDYS LABS SA | Discontinued | 30 Oct 2015 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/2 | 02554623 | 40 MG; 50 MG; 330 MG; 30 MG | CAPSULE · ORAL | APOTEX INC |
| APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4 | 02554615 | 15 MG; 330 MG; 50 MG; 40 MG | CAPSULE · ORAL | APOTEX INC |
| FIORINAL-C 1/2 | 00176206 | 30 MG; 50 MG; 40 MG; 330 MG | CAPSULE · ORAL | ARALEZ PHARMACEUTICALS CANADA INC |
| FIORINAL-C 1/4 | 00176192 | 40 MG; 15 MG; 50 MG; 330 MG | CAPSULE · ORAL | ARALEZ PHARMACEUTICALS CANADA INC |
| TEVA-TECNAL C 1/2 | 00608181 | 40 MG; 30 MG; 330 MG; 50 MG | CAPSULE · ORAL | TEVA CANADA LIMITED |
| TEVA-TECNAL C 1/4 | 00608203 | 15 MG; 40 MG; 330 MG; 50 MG | CAPSULE · ORAL | TEVA CANADA LIMITED |
Components
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.