Codeine shortage — CA supply status & alternatives

Codeine

ATC R05DA04

🇦🇺 AUST R 338093 · Sanofi-Aventis Australia Pty Ltd

In supply · Australia

WHO Essential Medicine

NoumedSirupus Codeini ConformaACTACODE codeine linctus oral liquid bottle

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇧🇪 BE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$3.96DPMQ A$24.24details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Codeine
Brand names	Noumed, Sirupus Codeini Conforma, ACTACODE codeine linctus oral liquid bottle
ATC level 5	R05DA04
ATC level 4	R05DA
Therapeutic category	Auto-created by Federal Agency for Medicines and Health Products — PharmaStatus scraper
WHO Essential Medicine	Yes · 2.2. Opioid analgesics (2023)
Controlled substance	No
Marketing-authorisation holders	Sanofi-Aventis Australia Pty Ltd, iNova Pharmaceuticals Australia Pty Ltd, Cipla Australia Pty Ltd, THE BOOTS COMPANY PLC +6 more
Registrations on file	25
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$3.96

AEMP

Dispensed (DPMQ)

A$24.24

incl. fees

Pack

codeine phosphate hemihydrate 30 mg tablet, 20

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£17.34

concession

🇫🇷 FR

€1.86

Retail price

🇺🇸 US

US$0.69

Acquisition

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

1 API manufacturer

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Very high concentration risk

Specgx LLC

Manufacturing countries: United States · Source: FDA List of Drug Master Files

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders25 registrations · 10 MA holders

Product	Strength	Form	Market	MA holder	Status
APX-PARACETAMOL/CODEINE paracetamol	500 mg	—	🇦🇺 AU	Sanofi-Aventis Australia Pty Ltd	Active
Gold Cross Codeine Linctus codeine phosphate hemihydrate	5 mg	—	🇦🇺 AU	iNova Pharmaceuticals Australia Pty Ltd	Active
Cipla Pain Relief Paracetamol 500 + Codeine	500 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
ACTACODE codeine linctus oral liquid bottle	—	—	🇦🇺 AU	—	Active
IBUPROFEN CODEINE-DWRN tablet blister pack	—	—	🇦🇺 AU	—	Active
IBUPROFEN CODEINE-RJIC tablet blister pack	—	—	🇦🇺 AU	—	Active
CHEMISTS' OWN STRONG PAIN EXTRA paracetamol	500mg	—	🇦🇺 AU	—	Active
Ibuprofen/Codeine-Wgr	—	—	🇦🇺 AU	—	Active
Paracetamol And Codeine Caplets	—	paracetamol	🇬🇧 GB	THE BOOTS COMPANY PLC	Active
Paracetamol & Codeine	—	capsule	🇬🇧 GB	THE BOOTS COMPANY PLC	Active
Boots Paracetamol And Codeine Extra	—	capsule	🇬🇧 GB	THE BOOTS COMPANY PLC	Active
Ibuprofen And Codeine	200MG	tablet	🇬🇧 GB	THE BOOTS COMPANY PLC	Active
Paracetamol And Codeine	500MG	tablet	🇬🇧 GB	THE BOOTS COMPANY PLC	Active
Dihydrocodeine Tablets Bp	30 MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Codeine Phosphate Tablets Bp	15MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active

+10 more registrations on file

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.