BENTYLOL TABLET 10MG 10 MG — DIN 02103087
DICYCLOMINE HYDROCHLORIDE : 10 MG · APTALIS PHARMA CANADA ULC · TABLET · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is BENTYLOL TABLET 10MG?
BENTYLOL TABLET 10MG 10 MG contains DICYCLOMINE HYDROCHLORIDE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02103087, held by APTALIS PHARMA CANADA ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 19-Nov-2018. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
What is BENTYLOL TABLET 10MG used for?
Functional gastrointestinal tract conditions involving smooth muscle spasm (irritable colon, spastic constipation) and adjunctive therapy in organic GI conditions.
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 Dicycloverine 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 Dicycloverine, across 15 DINs, of which 3 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 |
|---|---|---|---|---|
| JAMP PHARMA CORPORATION | 2 | 2 | JAMP-DICYCLOMINE HCL | Sourceable in Canada |
| LABORATOIRE RIVA INC. | 1 | 1 | RIVA-DICYCLOMINE | Sourceable in Canada |
| APTALIS PHARMA CANADA ULC | 3 | 0 | BENTYLOL, BENTYLOL TABLET 10MG, BENTYLOL TABLET 20MG | No marketed DIN |
| MERRELL PHARMS INC., DIVISION OF MERRELL DOW (CAN) | 2 | 0 | BENTYLOL DOSPAN 30MG, BENTYLOL INJ 10MG/ML | No marketed DIN |
| PRO DOC LIMITEE | 2 | 0 | PROTYLOL, PROTYLOL TAB 20MG | No marketed DIN |
| SANDOZ CANADA INCORPORATED | 2 | 0 | DICYCLOMINE HYDROCHLORIDE INJECTION USP, DICYCLOMINE HYDROCHLORIDE USP | No marketed DIN |
| DUCHESNAY INC | 1 | 0 | DICYCLOMINE CAP 10MG | No marketed DIN |
| MEDIC LABORATORY LTÉE | 1 | 0 | VISCEROL CAP 10MG | No marketed DIN |
| VALEANT CANADA LP / VALEANT CANADA S.E.C. | 1 | 0 | FORMULEX CAP 10MG | 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 | 10 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Tablets: Bottles of 100. Syrup: Bottles of 250 mL. |
| Storage | Store at room temperature (15-30°C). Protect from excessive heat and moisture. |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
Substance and classification
| Active substance | Dicycloverine |
|---|---|
| ATC code | A03AA07 |
| AHFS class | 12:08.08 |
| 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) | 02103087 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2103087 |
| Brand name | BENTYLOL TABLET 10MG |
| Generic / active ingredient | DICYCLOMINE HYDROCHLORIDE : 10 MG |
| Market authorization holder | APTALIS PHARMA CANADA ULC |
| Health Canada schedule | Ethical |
| ATC code | A03AA07 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A03AA |
| Current status | CANCELLED POST MARKET |
| Status date | 19-Nov-2018 |
| Original market date | 1995-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Adults: 10-20 mg 3-4 times daily (max 160 mg/day). Children (2-12 yrs): 10 mg 3-4 times daily. Infants (6 mo-2 yrs): 5-10 mg 3-4 times daily, 15 min before feeding.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Infants <6 months; nursing mothers; obstructive uropathy/GI disease; paralytic ileus; severe ulcerative colitis; myasthenia gravis; reflux esophagitis; glaucoma; unstable cardiovascular status.
Warnings and precautions
Serious respiratory symptoms and deaths reported in infants. May cause drowsiness or blurred vision. Psychosis and delirium reported in sensitive individuals.
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
3 of 15 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| JAMP-DICYCLOMINE HCL | 10 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | 02391619 |
| JAMP-DICYCLOMINE HCL | 20 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | 02366088 |
| RIVA-DICYCLOMINE | 10 MG | CAPSULE | LABORATOIRE RIVA INC. | MARKETED | 00557102 |
| BENTYLOL | 10 MG / 5 ML | SYRUP | APTALIS PHARMA CANADA ULC | CANCELLED POST MARKET | 02102978 |
| BENTYLOL DOSPAN 30MG | 30 MG | TABLET (EXTENDED-RELEASE) | MERRELL PHARMS INC., DIVISION OF MERRELL DOW (CAN) | CANCELLED POST MARKET | 00218723 |
| BENTYLOL INJ 10MG/ML | 10 MG | LIQUID | MERRELL PHARMS INC., DIVISION OF MERRELL DOW (CAN) | CANCELLED POST MARKET | 00133965 |
| BENTYLOL TABLET 20MG | 20 MG | TABLET | APTALIS PHARMA CANADA ULC | CANCELLED POST MARKET | 02103095 |
| DICYCLOMINE CAP 10MG | 10 MG | CAPSULE | DUCHESNAY INC | CANCELLED POST MARKET | 00431028 |
| DICYCLOMINE HYDROCHLORIDE INJECTION USP | 10 MG | SOLUTION | SANDOZ CANADA INCORPORATED | CANCELLED POST MARKET | 00392812 |
| DICYCLOMINE HYDROCHLORIDE USP | 10 MG | CAPSULE | SANDOZ CANADA INCORPORATED | CANCELLED POST MARKET | 00392820 |
2 · Same class — other molecules in ATC A03AA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Trimebutine | APO-TRIMEBUTINE · MINT-TRIMEBUTINE · MODULON · MODULON INJ 50MG/5ML · +1 more | 7 | 4 | Yes |
| Dicycloverine | BENTYLOL · BENTYLOL DOSPAN 30MG · BENTYLOL INJ 10MG/ML · BENTYLOL TABLET 10MG · +10 more | 15 | 3 | Yes |
| Dicycloverine, Combinations | DICLOPHEN · SPASMO NIL 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 A03A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| A03AX | Pinaverium · Silicones | 57 | 14 |
| A03AB | Glycopyrronium · Propantheline | 18 | 8 |
| A03AD | Papaverine | 1 | 1 |
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.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.