CHOLEDYL EXPECTORANT 50 MG / 5 ML — DIN 00476374
GUAIFENESIN : 50 MG / 5 ML OXTRIPHYLLINE : 100 MG / 5 ML · SEARCHLIGHT PHARMA INC · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is CHOLEDYL EXPECTORANT?
CHOLEDYL EXPECTORANT 50 MG / 5 ML contains GUAIFENESIN : 50 MG / 5 ML OXTRIPHYLLINE : 100 MG / 5 ML. It is listed in the Health Canada Drug Product Database under DIN 00476374, held by SEARCHLIGHT PHARMA INC, supplied as SOLUTION for ORAL administration. Health Canada currently lists it as marketed, status dated 20-Oct-2022. 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 CHOLEDYL EXPECTORANT used for?
Symptomatic relief of reversible bronchoconstriction associated with bronchial asthma, chronic obstructive pulmonary emphysema, chronic bronchitis, and where expectoration is required.
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 Theophylline, Combinations Excl. 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.
8 holders have a Canadian DIN containing Theophylline, Combinations Excl. Psycholeptics, across 12 DINs, of which 1 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 |
|---|---|---|---|---|
| SEARCHLIGHT PHARMA INC | 1 | 1 | CHOLEDYL EXPECTORANT | Sourceable in Canada |
| BAXTER CORPORATION | 3 | 0 | THEOPHYLLINE 0.8MG AND 5% DEXTROSE INJ, THEOPHYLLINE 1.6MG AND 5% DEXTROSE INJ, THEOPHYLLINE 4MG AND 5% DEXTROSE INJ | No marketed DIN |
| ROUGIER PHARMA DIVISION OF RATIOPHARM INC | 3 | 0 | I D M EXPECTORANT TAB, IDM TAB, THEOPHYLLINE ROUGIER ELIXIR | No marketed DIN |
| CARMARAN LTÉE | 1 | 0 | BRONCHYL SYR | No marketed DIN |
| HOSPIRA HEALTHCARE ULC | 1 | 0 | THEOPHYLLINE 0.8MG/ML IN 5% DEXTROSE INJ | No marketed DIN |
| LES LABORATOIRES BIO-SANTÉ INC. | 1 | 0 | PULMO SEPTOL SIROP | No marketed DIN |
| PHARMASCIENCE INC | 1 | 0 | PMS-OXTRIPHYLLINE ELIXIR | No marketed DIN |
| RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | 1 | 0 | RATIO-THEO-BRONC | 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 / 5 ML |
|---|---|
| Dosage form | SOLUTION |
| Route | ORAL |
| Pack configuration (monograph) | Bottles of 250 mL and 500 mL. |
| Storage | Store at controlled room temperature 15 to 25°C. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Substance and classification
| Active substance | Theophylline, Combinations Excl. Psycholeptics |
|---|---|
| ATC code | R03DA54 |
| AHFS class | 48:16.00 ; 86:16.00 |
| 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) | 00476374 |
|---|---|
| DIN (unpadded, as printed on some documents) | 476374 |
| Brand name | CHOLEDYL EXPECTORANT |
| Generic / active ingredient | GUAIFENESIN : 50 MG / 5 ML OXTRIPHYLLINE : 100 MG / 5 ML |
| Market authorization holder | SEARCHLIGHT PHARMA INC |
| Health Canada schedule | Prescription |
| ATC code | R03DA54 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R03DA |
| Current status | MARKETED |
| Status date | 20-Oct-2022 |
| Original market date | 1981-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Patients over 14 years: 10 mL 4 times daily; 10 to 14 years: 5 mL 4 times daily. Not recommended for children under 10 years of age.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to theophylline derivatives; coronary artery disease where myocardial stimulation is harmful; underlying seizure disorders; peptic ulcer.
Warnings and precautions
Small margin of safety in children. Serious toxicity (arrhythmias, convulsions, death) may occur without warning. Reduced clearance in elderly, hepatic/cardiac failure, or viral infections.
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
1 of 12 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| BRONCHYL SYR | 500 MG / 10 ML | LIQUID | CARMARAN LTÉE | CANCELLED POST MARKET | 00545090 |
| I D M EXPECTORANT TAB | 12 MG | TABLET | ROUGIER PHARMA DIVISION OF RATIOPHARM INC | CANCELLED POST MARKET | 00334510 |
| IDM TAB | 140 MG | TABLET | ROUGIER PHARMA DIVISION OF RATIOPHARM INC | CANCELLED POST MARKET | 00356123 |
| PMS-OXTRIPHYLLINE ELIXIR | 20 MG | ELIXIR | PHARMASCIENCE INC | CANCELLED POST MARKET | 00792942 |
| PULMO SEPTOL SIROP | .06 MG | SYRUP | LES LABORATOIRES BIO-SANTÉ INC. | CANCELLED POST MARKET | 00721301 |
| RATIO-THEO-BRONC | 16 MG | SYRUP | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | CANCELLED POST MARKET | 00317225 |
| THEOPHYLLINE 0.8MG AND 5% DEXTROSE INJ | .8 MG | SOLUTION | BAXTER CORPORATION | CANCELLED POST MARKET | 00828718 |
| THEOPHYLLINE 0.8MG/ML IN 5% DEXTROSE INJ | 5.0 % | SOLUTION | HOSPIRA HEALTHCARE ULC | CANCELLED POST MARKET | 00640093 |
| THEOPHYLLINE 1.6MG AND 5% DEXTROSE INJ | 50 MG | SOLUTION | BAXTER CORPORATION | CANCELLED POST MARKET | 00828726 |
| THEOPHYLLINE 4MG AND 5% DEXTROSE INJ | 4 MG | SOLUTION | BAXTER CORPORATION | CANCELLED POST MARKET | 00828742 |
2 · Same class — other molecules in ATC R03DA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Theophylline | AA-THEO LA · APO-THEO ER · ELIXIR DE THEOPHYLLINE · PMS-THEOPHYLLINE ELIXIR · +27 more | 39 | 6 | Yes |
| Theophylline, Combinations Excl. Psycholeptics | BRONCHYL SYR · CHOLEDYL EXPECTORANT · I D M EXPECTORANT TAB · IDM TAB · +8 more | 12 | 1 | Yes |
| Aminophylline | AMINOPHYLLINE INJ 25MG/ML · AMINOPHYLLINE INJ 50MG/ML · AMINOPHYLLINE INJECTION 50MG/ML · AMINOPHYLLINE TAB 0.1GM · +4 more | 9 | 1 | Yes |
| Choline Theophyllinate | APO OXTRIPHYLLINE TAB 100MG · APO OXTRIPHYLLINE TAB 200MG · APO OXTRIPHYLLINE TAB 300MG · CHOLEDYL · +13 more | 17 | 0 | Not in Canada |
| Diprophylline | PROTOPHYLLINE ELIXIR 100MG · PROTOPHYLLINE INJ 500MG/2ML · PROTOPHYLLINE SOLUTION 100MG · PROTOPHYLLINE SUP 500MG ADULTES · +1 more | 5 | 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 R03D
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R03DC | Montelukast · Zafirlukast | 98 | 41 |
| R03DX | Benralizumab · Mepolizumab · Omalizumab · Reslizumab · Roflumilast · +1 more | 19 | 17 |
| R03DB | Theophylline And Adrenergics | 1 | 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.