Current list of up-scheduled codeine containing products

15 June 2018

TGA has amended all previously Schedule 2 (Pharmacy Only) and Schedule 3 (Pharmacist Only) codeine containing products to Schedule 4 (Prescription Only) to reflect the scheduling decision from 1 February 2018.

However, not all products now denoted as Schedule 4 on the Australian Register of Therapeutic Goods (ARTG) are suitable for supply to the market.

Sponsors that wish to continue supplying their goods that were previously S2/S3 goods and are now S4 medicines, need to have applied to TGA for specific changes to their labelling, indications and Product Information to ensure safe and effective use of the goods as S4 medicines.

The list of upscheduled products below is a list of goods which have gone through this process and are approved for market supply by TGA.

Goods which are not on this list may be currently going through the up-scheduling process.

You should contact the sponsor to confirm their intention to continue marketing their goods in Australia, after 1 February 2018.

Products containing other codeine derivatives, such as pholcodine, dextromethorphan, and dihydrocodeine are unaffected by the decision to up-schedule codeine.

List of up-scheduled codeine containing products
Sponsor Codeine-containing products previously available over-the-counter that have been up-scheduled to prescription medicines (S4) AUST R
Apotex Pty Ltd APO-IBUPROFEN/CODEINE tablet blister pack 227876
MEVADOL tablet blister pack 230135
APO-PARACETAMOL/CODEINE 500/10 tablet blister pack 229518
APO-PARACETAMOL/CODEINE 500/15 tablet blister pack 229524
Arrow Pharma Pty Ltd CHEMISTS' OWN PAIN CAPTABS capsule shaped tablet blister pack 93812
CHEMISTS' OWN PAIN TABLETS tablet blister pack 93836
CHEMISTS' OWN PAIN TABLETS tablet bottle 93828
CHEMIST'S OWN IBUPROFEN PLUS CODEINE tablet blister pack 158210
CHEMISTS' OWN STRONG PAIN EXTRA tablet blister pack 208276
Aspen Pharma Pty Ltd ASPALGIN dispersible tablet blister pack 13431
DOLASED ANALGESIC-CALMATIVE tablet blister pack 157880
Care Pharmaceuticals Pty Ltd PAINSTOP NIGHT-TIME PAIN RELIEVER oral liquid bottle 20864
PAINSTOP DAY-TIME PAIN RELIEVER oral liquid bottle (reformulation) 131721
Cipla Australia Pty Ltd CIPLA COLD & FLU PE DAY paracetamol 500mg, phenylephrine hydrochloride 5mg & codeine phosphate hemihydrate 6mg tablets blister pack 219457
CIPLA PAIN RELIEF PARACETAMOL + CODEINE 10 tablet blister pack 144070
MEDITAB PARACETAMOL PLUS CODEINE tablet blister pack 184463
FEBRIDOL CO tablet bottle 196355
CIPLA PAIN RELIEF IBUPROFEN PLUS tablet blister pack 155753
AMCAL IBUPROFEN PLUS CODEINE tablet blister pack 227475
PHARMACY CARE IBUPROFEN PLUS CODEINE tablet blister pack 227476
CHEMISTS OWN PARACETAMOL PLUS CODEINE & CALMATIVE tablet blister pack 277276
CIPLA PAIN RELIEF PARACETAMOL + CODEINE with CALMATIVE tablet blister pack 140610
CODOXAMOL tablet bottle 161869
CIPLA PAIN RELIEF PARACETAMOL + CODEINE 15, paracetamol 500mg + codeine phosphate hemihydrate 15mg tablets blister pack 188893
FEBRIDOL XTRA PARACETAMOL AND CODEINE Paracetamol 500mg + Codeine Phosphate15mg tablets blister pack 210575
CIPLA COLD & FLU DAY/NIGHT tablets blister pack 223596
CIPLA COLD & FLU DAY TABLETS Paracetamol 500 mg Pseudoephedrine Hydrochloride 30mg and codeine phosphate hemihydrate 6mg uncoated tablets blister pack 216069
Medreich Australia Pty Ltd MEDREICH IBUPROFEN AND CODEINE PHOSPHATE tablet blister pack 175119
MEDREICH PARACETAMOL and CODEINE PHOSPHATE HEMIHYDRATE tablet blister pack 188379
MEDREICH PARACETAMOL CODEINE PHOSPHATE AND DOXYLAMINE SUCCINATE tablet blister pack 202702
BRUFEN PLUS 200/12.8 Ibuprofen 200 mg and codeine phosphate hemihydrate 12.8 mg tablet blister pack 298439
Neo Health (OTC) Pty Ltd PARACODE paracetamol 500 mg and codeine phosphate hemihydrate 8 mg tablet blister pack 292799
PARACODE EXTRA paracetamol 500 mg and codeine phosphate hemihydrate 15 mg tablet blister pack 292800
Pharmacor Pty Ltd TRUST ANALGESIC CALMATIVE tablets blister pack 217762
MYDOL 15 tablet blister pack 188381
TRUST IBUPROFEN PLUS CODEINE tablet blister pack 175264
Reckitt Benckiser Pty Ltd NUROFEN PLUS tablet blister pack (reformulation) 116620
Sandoz Pty Ltd SANDOZ COLD & FLU RELIEF PE tablet blister pack 211402
SANDOZ ANALGESIC/CALMATIVE paracetamol 500mg + codeine phosphate hemihydrate 10mg + doxylamine succinate 5.1mg tablet blister pack 211514
SANDOZ PARACETAMOL PLUS CODEINE paracetamol 500mg and codeine phosphate hemihydrate 15mg tablets blister pack 212684
SANDOZ IBUPROFEN PLUS CODEINE film coated tablet blister pack 211512
Sanofi-Aventis Australia Pty Ltd MERSYNDOL CAPLETS tablet blister pack 56535
MERSYNDOL DAYSTRENGTH tablet blister pack 59985
MERSYNDOL tablet blister pack 10110
PANALGESIC capsules blister pack 15489
PANAMAX CO tablet blister pack 62661
PRODEINE tablet blister pack 200605
PRODEINEXTRA tablet blister pack 205550
Sigma Company Limited AMCAL STRONG PAIN RELIEF EXTRA tablets 208319
AMCAL STRONG PAIN RELIEF PLUS Paracetamol 500mg, codeine phosphate hemihydrate 10mg and Doxylamine succinate 5.1mg tablet blister pack 224164
CODASIG paracetamol 500mg and codeine phosphate hemihydrate 15 mg tablets blister pack 226290