ODAN-CYCLOPENTOLATE 1 % — DIN 00626627
CYCLOPENTOLATE HYDROCHLORIDE : 1 % · ODAN LABORATORIES LTD · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is ODAN-CYCLOPENTOLATE?
ODAN-CYCLOPENTOLATE 1 % contains CYCLOPENTOLATE HYDROCHLORIDE : 1 %. It is listed in the Health Canada Drug Product Database under DIN 00626627, held by ODAN LABORATORIES LTD, supplied as SOLUTION for OPHTHALMIC administration. Health Canada currently lists it as marketed, status dated 11-May-2021. 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 ODAN-CYCLOPENTOLATE used for?
Odan-Cyclopentolate (cyclopentolate hydrochloride ophthalmic solution, USP) is used to produce mydriasis and cycloplegia.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Cyclopentolate cost around the world?
Cyclopentolate is listed on 8 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Greece publishes a producer price (ex-factory); Luxembourg publishes a reimbursement; Morocco publishes a PPV (public price). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| Saudi Arabia | public | 12 | 12 | SAR███.██ |
| United States | acquisition | 2 | 4 | USD███.██ |
| United Kingdom | hospital | 2 | 2 | GBP███.██ |
| Luxembourg | reimbursement | 2 | 2 | EUR███.██ |
| South Africa | single exit price | 2 | 2 | ZAR███.██ |
| United Arab Emirates | public | 1 | 1 | AED███.██ |
| Greece | producer price (ex-factory) | 1 | 1 | EUR███.██ |
| Morocco | PPV (public price) | 1 | 1 | MAD███.██ |
25 pack listings across 23 brand entries and 7 price bases, refreshed 05 Sep 2026. Ranges span every Cyclopentolate pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Cyclopentolate 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.
7 holders have a Canadian DIN containing Cyclopentolate, across 9 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 |
|---|---|---|---|---|
| ODAN LABORATORIES LTD | 2 | 1 | ODAN-CYCLOPENTOLATE | Sourceable in Canada |
| ALCON CANADA INC | 1 | 1 | CYCLOGYL | Sourceable in Canada |
| BAUSCH & LOMB INC | 1 | 1 | MINIMS CYCLOPENTOLATE HYDROCHLORIDE | Sourceable in Canada |
| PHARMA STULLN INC. | 2 | 0 | CYCLOPENTOLATE | No marketed DIN |
| BAUSCH & LOMB INC 1400 N Goodman Street Rochester New York United States 14609 | 1 | 0 | MINIMS CYCLOPENTOLATE HYDROCHLORIDE | No marketed DIN |
| DOMINION PHARMACAL | 1 | 0 | DOM-CYCLOPENTOLATE HCL OPHTHALMIC SOLUTION-1% | No marketed DIN |
| PHARMASCIENCE INC | 1 | 0 | PMS-CYCLOPENTOLATE HCL OPH SOLUTION 1% | 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 | 1 % |
|---|---|
| Dosage form | SOLUTION |
| Route | OPHTHALMIC |
| Pack configuration (monograph) | Odan-Cyclopentolate is available in 10 mL multiple-dose plastic dropper bottles. Tamper evidence is provided by a closure with an extended skirt that locks to the bottle finish on application and breaks away from the closure on opening. After cap is removed: if tamper evident snap collar is loose, remove before using product. |
| Storage | Store at 15°C - 30°C. Keep container tightly closed. Keep out of the reach and sight of children. |
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 | Cyclopentolate |
|---|---|
| ATC code | S01FA04 |
| AHFS class | 52:24.00 |
| 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) | 00626627 |
|---|---|
| DIN (unpadded, as printed on some documents) | 626627 |
| Brand name | ODAN-CYCLOPENTOLATE |
| Generic / active ingredient | CYCLOPENTOLATE HYDROCHLORIDE : 1 % |
| Market authorization holder | ODAN LABORATORIES LTD |
| Health Canada schedule | Prescription |
| ATC code | S01FA04 |
| ATC anatomical main group | S — Sensory organs |
| ATC therapeutic subgroup | S01FA |
| Current status | MARKETED |
| Status date | 11-May-2021 |
| Original market date | 1984-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Patients must be instructed to remove contact lenses prior to application of Odan-Cyclopentolate and wait at least 15 minutes before re-insertion. Odan-Cyclopentolate contains the preservative benzalkonium chloride, which may cause eye irritation and is known to discolour soft contact lenses. Dosing Considerations: Individuals with heavily pigmented irides may require larger doses. Recommended Dose: Adults: One drop in the eye(s), followed by a second drop in 5 minutes, if necessary. Complete recovery usually occurs in 24 hours. Pediatrics (≥6 years of age): One drop in the eye(s), followed by a second drop 5 minutes later, if necessary. Pretreatment with Odan-Cyclopentolate on the day prior to examination is usually not necessary. Pediatrics (<6 years of age): Odan-Cyclopentolate should not be used in pediatric patients <6 years of age (see CONTRAINDICATIONS). Administration: Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decreased in systemic adverse reactions.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Odan-Cyclopentolate is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the Prescribing Information. • Patients with known or suspected angle-closure glaucoma. • Pediatric patients < 6 years of age.
Warnings and precautions
General: Odan-Cyclopentolate is for topical use only and is not for injection. Odan-Cyclopentolate should be used with caution in patients, especially children, who have previously had a severe systemic reaction to atropine. Because of the risk of provoking hyperthermia, Odan-Cyclopentolate should be used with caution in patients, especially children, who may be exposed to elevated environmental temperatures or who are febrile. Ophthalmologic: Odan-Cyclopentolate may cause increased intraocular pressure (IOP). In the elderly and others where increased IOP may be encountered, mydriatics and cycloplegics should be used cautiously. To avoid inducing angle closure glaucoma, IOP and an estimation of the depth of the angle of the anterior chamber should be made prior to initiation of therapy. Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation. Cyclopentolate may cause drowsiness, blurred vision and sensitivity to light. Patients should be advised not to drive or engage in other hazardous activities unless vision is clear. Odan-Cyclopentolate contains the preservative benzalkonium chloride, which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses (see DOSAGE AND ADMINISTRATION). Psychiatric: Cyclopentolate-induced psychotic reactions and behavioural disturbances and other central nervous system (CNS) disturbances may occur in patients with increased susceptibility to anticholinergic drugs (see WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics (≥ 6 years of age) and Geriatrics (> 65 years of age)).
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 9 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| CYCLOGYL | 1 % | DROPS | ALCON CANADA INC | MARKETED | 00252506 |
| MINIMS CYCLOPENTOLATE HYDROCHLORIDE | 1 % | SOLUTION | BAUSCH & LOMB INC | MARKETED | 02148382 |
| CYCLOPENTOLATE | 0.5 % | SOLUTION | PHARMA STULLN INC. | CANCELLED POST MARKET | 02023687 |
| CYCLOPENTOLATE | 1 % | SOLUTION | PHARMA STULLN INC. | CANCELLED POST MARKET | 02023644 |
| DOM-CYCLOPENTOLATE HCL OPHTHALMIC SOLUTION-1% | 1 % | SOLUTION | DOMINION PHARMACAL | CANCELLED POST MARKET | 02181436 |
| MINIMS CYCLOPENTOLATE HYDROCHLORIDE | Strength | Solution | BAUSCH & LOMB INC 1400 N Goodman Street Rochester New York United States 14609 | DORMANT | 02148331 |
| ODAN-CYCLOPENTOLATE | 0.5 % | SOLUTION | ODAN LABORATORIES LTD | DORMANT | 00626635 |
| PMS-CYCLOPENTOLATE HCL OPH SOLUTION 1% | 1 % | LIQUID | PHARMASCIENCE INC | CANCELLED POST MARKET | 00878189 |
2 · Same class — other molecules in ATC S01FA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Tropicamide | MINIMS TROPICAMIDE · MYDRIACYL · ODAN-TROPICAMIDE · PMS-TROPICAMIDE OPH SLTN 1% · +3 more | 10 | 4 | Yes |
| Atropine | ALCON ATROPINE · ATROPINE · ATROPINE 1% · ATROPINE ONT 1% · +6 more | 10 | 3 | Yes |
| Cyclopentolate | CYCLOGYL · CYCLOPENTOLATE · DOM-CYCLOPENTOLATE HCL OPHTHALMIC SOLUTION-1% · MINIMS CYCLOPENTOLATE HYDROCHLORIDE · +2 more | 9 | 3 | Yes |
| Homatropine | ISOPTO HOMATROPINE 2% · ISOPTO HOMATROPINE 5% · MINIMS HOMATROPINE HYDROBROMIDE 2% | 3 | 0 | Not in Canada |
| Tropicamide, Combinations | DIOPHENYL-T SOLUTION · PHENYLTROPE OPH SOLN | 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 S01F
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| S01FB | Phenylephrine | 5 | 3 |
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.
What else is ODAN-CYCLOPENTOLATE called?
Also recorded in Canada as: cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [Cyclogyl] (US), cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [Cylate] (US), cyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic Solution [Cyclomydril] (US), cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution [Cyclogyl] (US), cyclopentolate hydrochloride 5 MG/ML Ophthalmic Solution [Cyclogyl] (US), cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution (US), cyclopentolate hydrochloride 2 MG/ML / phenylephrine hydrochloride 10 MG/ML Ophthalmic Solution (US), cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution (US), cyclopentolate hydrochloride 5 MG/ML Ophthalmic Solution (US), CYCLOPENTOLATE HYDROCHLORIDE (US), CYCLOPENTOLATE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (US).
The same molecule, Cyclopentolate, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Cyclomydril | Latin | South Africa |
| SKIACOL | Latin | Morocco |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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.