FIORINAL 50 MG — DIN 00226327
BUTALBITAL : 50 MG ACETYLSALICYLIC ACID : 330 MG CAFFEINE : 40 MG · ARALEZ PHARMACEUTICALS CANADA INC · CAPSULE · wholesale supply in Canada
Health Canada status: MARKETED
What is FIORINAL?
FIORINAL 50 MG contains BUTALBITAL : 50 MG ACETYLSALICYLIC ACID : 330 MG CAFFEINE : 40 MG. It is listed in the Health Canada Drug Product Database under DIN 00226327, held by ARALEZ PHARMACEUTICALS CANADA INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 21-Jan-2020. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is FIORINAL used for?
Indicated for the relief of tension-type headache. Not recommended for multiple recurrent headaches due to risk of medication overuse headache.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Acetylsalicylic Acid, Comb With Psycholeptics in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
9 holders have a Canadian DIN containing Acetylsalicylic Acid, Comb With Psycholeptics, across 14 DINs, of which 5 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| TEVA CANADA LIMITED | 2 | 2 | TEVA-TECNAL | Sourceable in Canada |
| LABORATOIRE RIVA INC. | 2 | 1 | TRIANAL CAPSULES, TRIANAL TABLET | Sourceable in Canada |
| APOTEX INC | 1 | 1 | APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE | Sourceable in Canada |
| ARALEZ PHARMACEUTICALS CANADA INC | 1 | 1 | FIORINAL | Sourceable in Canada |
| PHARMASCIENCE INC | 3 | 0 | PMS-PHARNAL CAPSULES, PMS-PHARNAL TABLETS, PMS-PHARNAL-C 1/4 CAPSULES | No marketed DIN |
| PRO DOC LIMITEE | 2 | 0 | PRONAL CAPSULES, PRONAL TABLETS | No marketed DIN |
| MERCK FROSST CANADA & CIE, MERCK FROSST CANADA & CO. | 1 | 0 | 282 MEP TAB | No marketed DIN |
| NOVARTIS PHARMACEUTICALS CANADA INC | 1 | 0 | FIORINAL TAB | No marketed DIN |
| WYETH-AYERST CANADA INC. | 1 | 0 | EQUAGESIC TABLETS | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 50 MG |
|---|---|
| Dosage form | CAPSULE |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in provided text (mentions 'Capsules' and 'USP'). |
| Storage | Not explicitly detailed in provided text. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Acetylsalicylic Acid, Comb With Psycholeptics |
|---|---|
| ATC code | N02BA71 |
| AHFS class | 28:08.04.24 ; 28:24.04 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 00226327 |
|---|---|
| DIN (unpadded, as printed on some documents) | 226327 |
| Brand name | FIORINAL |
| Generic / active ingredient | BUTALBITAL : 50 MG ACETYLSALICYLIC ACID : 330 MG CAFFEINE : 40 MG |
| Market authorization holder | ARALEZ PHARMACEUTICALS CANADA INC |
| Health Canada schedule | CONTROLLED DRUGS (CDSA IV) |
| ATC code | N02BA71 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N02BA |
| Current status | MARKETED |
| Status date | 21-Jan-2020 |
| Original market date | 1971-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
1 or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules. Extended use is not recommended due to habit-forming potential.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to ASA, caffeine, or butalbital; hemorrhagic diathesis; nasal polyps/angioedema/bronchospasm to NSAIDs; peptic ulcer; porphyria; history of drug/alcohol abuse; 3rd trimester pregnancy.
Warnings and precautions
Butalbital is habit-forming and potentially abusable. Risk of medication overuse headache. ASA can cause anaphylaxis and serious GI bleeding. Risk of Reye's syndrome in young adults.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
5 of 14 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE | 40 MG | CAPSULE | APOTEX INC | MARKETED | 02554690 |
| TEVA-TECNAL | 50 MG | TABLET | TEVA CANADA LIMITED | MARKETED | 00608211 |
| TEVA-TECNAL | 50 MG | CAPSULE | TEVA CANADA LIMITED | MARKETED | 00608238 |
| TRIANAL TABLET | 330 MG | TABLET | LABORATOIRE RIVA INC. | MARKETED | 01971409 |
| 282 MEP TAB | 30 MG | TABLET | MERCK FROSST CANADA & CIE, MERCK FROSST CANADA & CO. | CANCELLED POST MARKET | 00108316 |
| EQUAGESIC TABLETS | 75 MG | TABLET | WYETH-AYERST CANADA INC. | CANCELLED POST MARKET | 02041804 |
| FIORINAL TAB | 50 MG | TABLET | NOVARTIS PHARMACEUTICALS CANADA INC | CANCELLED POST MARKET | 00275328 |
| PMS-PHARNAL CAPSULES | 40 MG | CAPSULE | PHARMASCIENCE INC | CANCELLED PRE MARKET | 02232988 |
| PMS-PHARNAL TABLETS | 50 MG | TABLET | PHARMASCIENCE INC | CANCELLED PRE MARKET | 02232989 |
| PMS-PHARNAL-C 1/4 CAPSULES | 15 MG | CAPSULE | PHARMASCIENCE INC | CANCELLED PRE MARKET | 02232985 |
2 · Same class — other molecules in ATC N02BA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Acetylsalicylic Acid | A.S.A. · A.S.A. (ACETYLSALICYLIC ACID) TAB 325MG USP · A.S.A. 325 MG TABLET · A.S.A. 80MG ACETYLSALICYLIC ACID TABLETS · +122 more | 146 | 15 | Yes |
| Acetylsalicylic Acid, Comb With Psycholeptics | 282 MEP TAB · APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE · EQUAGESIC TABLETS · FIORINAL · +9 more | 14 | 5 | Yes |
| Acetylsalicylic Acid, Comb Excl Psycholeptics | 217 · 217 STRONG TAB · ALKA SELTZER EVT · ALKA SELTZER FLAVOURED · +48 more | 54 | 0 | Not in Canada |
| Diflunisal | DIFLUNISAL · DIFLUNISAL-250 - TAB 250MG · DIFLUNISAL-500 - TAB 500MG · DOLOBID TAB 250MG · +4 more | 10 | 0 | Not in Canada |
| Salicylic Acid And Derivatives | ARTHRITEN TABLETS · BACK-ESE M TAB 325MG · BACK-ESE M TABLETS 325 MG · DOAN'S BACKACHE PILLS 325MG · +1 more | 5 | 0 | Not in Canada |
| Sodium Salicylate | DODD'S TABLETS REGULAR STRENGTH 325 MG · DODD'S TABLETS REGULAR STRENGTH 325MG · DODDS EXTRA STRENGTH TAB 500MG · DODDS PILLS | 5 | 0 | Not in Canada |
| Salicyloylsalicylic Acid | DISALCID - TAB 500MG · DISALCID - TAB 750MG · DISALCID TAB 500MG · DISALCID TAB 750MG | 4 | 0 | Not in Canada |
| Choline Salicylate, Comb. Excl Psycholeptics | TEEJEL GEL · TRILISATE TAB | 2 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC N02B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| N02BE | Acetaminophen (Paracetamol) · Acetaminophen, Comb Excl Psycholeptics | 1156 | 208 |
| N02BF | Gabapentin · Pregabalin | 432 | 168 |
| N02BG | Cannabinoids · Floctafenine · Methoxyflurane | 7 | 3 |
| N02BB | Phenazone, Combinations Excl Psycholeptics | 2 | 0 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.