OTI CAL 15.3 MG — DIN 00540943
BENZOCAINE : 15.3 MG ANTIPYRINE : 58 MG · PRODUITS FRANCAIS LABS INC. · DROPS · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is OTI CAL?
OTI CAL 15.3 MG contains BENZOCAINE : 15.3 MG ANTIPYRINE : 58 MG. It is listed in the Health Canada Drug Product Database under DIN 00540943, held by PRODUITS FRANCAIS LABS INC., supplied as DROPS for OTIC administration. Health Canada currently lists it as cancelled post market, status dated 30-May-1997. 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.
How much does Combinations cost around the world?
Combinations is listed on 4 of the national price registers Nexara ingests. Each country publishes on a different basis, so figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Czechia publishes a max producer price (ex-factory); Hungary publishes a producer price (ex-factory); Iceland publishes a max wholesale. 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 |
|---|---|---|---|
| Hungary | producer price (ex-factory) | 5 | 5 |
| Czechia | max producer price (ex-factory) | 1 | 1 |
| Iceland | max wholesale | 1 | 1 |
| Luxembourg | reimbursement | 1 | 1 |
8 pack listings across 8 brand entries and 4 price bases, refreshed 05 Sep 2026. Ranges span every Combinations pack in that market, so a high figure is usually a larger pack rather than the same product.
This table is a regulatory record of where the molecule is listed. The DIN on this page is no longer authorized for sale in Canada, so Nexara does not quote it — see the alternatives above.
Is there a generic Combinations 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 Combinations, across 7 DINs, of which 0 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 |
|---|---|---|---|---|
| LAB NADEAU LTÉE, DIVISION OF TECHNILAB INC. | 1 | 0 | AURISAN DPS | No marketed DIN |
| LAB VALMO ENREGISTRÉ, DIVISION OF TECHNILAB INC. | 1 | 0 | GOUTTES POUR MAL D'OREILLES | No marketed DIN |
| PALADIN PHARMA INC. | 1 | 0 | AURALGAN | No marketed DIN |
| PRODUITS FRANCAIS LABS INC. | 1 | 0 | OTI CAL | No marketed DIN |
| PRODUITS MARC-O (1987) INC., DIVISION OF TECHNILAB INC. | 1 | 0 | ORALGAR DPS | No marketed DIN |
| WYETH CANADA | 1 | 0 | AURALGAN EARDROPS | No marketed DIN |
| WYETH CONSUMER HEALTHCARE INC. | 1 | 0 | AURALGAN SOLUTION | 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 | 15.3 MG |
|---|---|
| Dosage form | DROPS |
| Route | OTIC |
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 | Combinations |
|---|---|
| ATC code | S02DA30 |
| 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) | 00540943 |
|---|---|
| DIN (unpadded, as printed on some documents) | 540943 |
| Brand name | OTI CAL |
| Generic / active ingredient | BENZOCAINE : 15.3 MG ANTIPYRINE : 58 MG |
| Market authorization holder | PRODUITS FRANCAIS LABS INC. |
| Health Canada schedule | NON-PRESCRIPTION DRUGS |
| ATC code | S02DA30 |
| ATC anatomical main group | S — Sensory organs |
| ATC therapeutic subgroup | S02DA |
| Current status | CANCELLED POST MARKET |
| Status date | 30-May-1997 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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
0 of 7 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| AURALGAN | 14 MG | SOLUTION | PALADIN PHARMA INC. | CANCELLED POST MARKET | 02332477 |
| AURALGAN EARDROPS | 14 MG | DROPS | WYETH CANADA | CANCELLED POST MARKET | 02041502 |
| AURALGAN SOLUTION | 54 MG | SOLUTION | WYETH CONSUMER HEALTHCARE INC. | CANCELLED POST MARKET | 01932403 |
| AURISAN DPS | 5 MG | DROPS | LAB NADEAU LTÉE, DIVISION OF TECHNILAB INC. | CANCELLED POST MARKET | 00417009 |
| GOUTTES POUR MAL D'OREILLES | 3.43 G / 100 ML | DROPS | LAB VALMO ENREGISTRÉ, DIVISION OF TECHNILAB INC. | CANCELLED POST MARKET | 00542865 |
| ORALGAR DPS | 165 MG / 30 ML | DROPS | PRODUITS MARC-O (1987) INC., DIVISION OF TECHNILAB INC. | CANCELLED POST MARKET | 00400602 |
2 · Same class — other molecules in ATC S02DA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Combinations | AURALGAN · AURALGAN EARDROPS · AURALGAN SOLUTION · AURISAN DPS · +3 more | 7 | 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 S02D
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| S02DC | Indifferent Preparations | 4 | 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.
What else is OTI CAL called?
The same molecule, Combinations, 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 |
|---|---|---|
| Ekyflogyl | Latin | Iceland |
| OTIPAX | Latin | Czechia |
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.
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.