Active substance
Codeine
- US FDA 3
- Health Canada 9
- US price lines 3
- NHS prices 7
- WHO EML 1
- Safety 12
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CODEINE SULFATE | 15MG; 30MG; 60MG | tablet · oral | HIKMA PHARMS | Prescription | 16 Jul 2009 |
| CODEINE SULFATE | 15MG; 30MG; 60MG | tablet · oral | LANNETT CO INC | Prescription | 13 Jun 2014 |
| CODEINE SULFATE | 30MG/5ML | solution · oral | HIKMA PHARMS | Discontinued | 30 Jun 2011 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| CODEINE 30 | 02009757 | 30 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
| CODEINE CONTIN 100MG CONTROLLED RELEASE TAB | 02163748 | 100 MG | TABLET (EXTENDED-RELEASE) · ORAL | PURDUE PHARMA |
| CODEINE CONTIN 150MG CONTROLLED RELEASE TAB | 02163780 | 150 MG | TABLET (EXTENDED-RELEASE) · ORAL | PURDUE PHARMA |
| CODEINE CONTIN 200MG CONTROLLED RELEASE TAB | 02163799 | 200 MG | TABLET (EXTENDED-RELEASE) · ORAL | PURDUE PHARMA |
| CODEINE CONTIN 50MG CONTROLLED RELEASE TAB | 02230302 | 50 MG | TABLET (EXTENDED-RELEASE) · ORAL | PURDUE PHARMA |
| CODEINE PHOSPHATE SYRUP | 00050024 | 25 MG / 5 ML | SYRUP · ORAL | LABORATOIRE ATLAS INC |
| LINCTUS CODEINE BLANC | 00380571 | 10 MG / 5 ML | SOLUTION · ORAL | LABORATOIRE ATLAS INC |
| TEVA-CODEINE | 00593435 | 15 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TEVA-CODEINE | 00593451 | 30 MG | TABLET · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | CODEINE SULFATE 15 MG TABLET | $0.67735 | per EA | 23 Sep 2026 |
| US NADAC | CODEINE SULFATE 30 MG TABLET | $0.72645 | per EA | 23 Sep 2026 |
| US NADAC | CODEINE SULFATE 60 MG TABLET | $1.27998 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Codeine 15mg tablets | £0.95 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Codeine 15mg tablets | £3.39 | 100 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Codeine 15mg/5ml linctus | £19.50 | 200 ml | 1 Oct 2026 |
| NHS Drug Tariff | Codeine 15mg/5ml linctus sugar free | £25.68 | 200 ml | 1 Oct 2026 |
| NHS Drug Tariff | Codeine 30mg tablets | £1.15 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Codeine 30mg tablets | £4.11 | 100 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Codeine 60mg tablets | £1.98 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 2.2. Opioid analgesics · core
Pain
Oral > Solid: 30 mg tablet (codeine phosphate)
Safety signals and safety-related labeling changes
- US FDA 10 Jul 2026 TUXARIN ER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 CODEINE SULFATE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 CODEINE SULFATE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 FIORICET W/ CODEINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 PHENERGAN VC W/ CODEINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 PHENERGAN W/ CODEINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 28 Apr 2021 FIORINAL W/CODEINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 28 Jun 2018 CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 11 Dec 2014 Codeine: restricted use as analgesic in children and adolescents after European safety review
- MHRA 11 Dec 2014 Codeine: very rare risk of side-effects in breastfed babies
Breastfed babies might very rarely develop side-effects due to the presence of morphine in breast milk. - EMA PRAC 3 Oct 2012 PRAC signal: Fatal or life-threatening drug toxicity in CYP2D6 ultra-rapid metabolisers
Action for MAH: update of the product information: No - EMA PRAC 5 Sep 2012 PRAC signal: Fatal or life-threatening drug toxicity in CYP2D6 ultra-rapid metabolisers
Action for MAH: update of the product information: No
Combinations containing Codeine
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.