Overview
The relief of pain (analgesia) is a primary goal for enhancing the quality of life of patients and for increasing the ability of patients to engage in day to day activities. Codeine, an opioid analgesic, was originally approved in the US in 1950 and is a drug used to decrease pain by increasing the threshold for pain without impairing consciousness or altering other sensory functions. Opiates such as codeine are derived from the poppy plant, Papaver somniferum (Papaveraceae). Codeine is utilized as a central analgesic, sedative, hypnotic, antinociceptive, and antiperistaltic agent, and is also recommended in certain diseases with incessant coughing.
Indication
Codeine sulfate is a form of this drug that is commonly used. It is available in tablet form and indicated for the relief of mild to moderately severe pain, where the use of an opioid analgesic is appropriate . The solution form is used by itself or combined in a syrup with other drugs and is used as a cough suppressant in adults aged 18 and above , .
Associated Conditions
- Common Cold
- Cough
- Flu caused by Influenza
- Mild pain
- Pain
- Severe Pain
- Dry cough
- Moderate Pain
- Upper respiratory symptoms
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/10/08 | Phase 1 | Completed | |||
2015/09/11 | Phase 4 | Completed | |||
2014/11/20 | Not Applicable | Completed | |||
2013/05/03 | Phase 1 | Completed | Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH | ||
2013/02/11 | Phase 1 | Completed | |||
2012/08/31 | Phase 3 | Terminated | |||
2012/08/24 | Phase 4 | Completed | Tan Tock Seng Hospital | ||
2011/07/26 | Phase 3 | Completed | |||
2011/03/24 | Phase 1 | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||
2010/12/28 | Phase 4 | Completed |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eywa Pharma Inc | 71930-056 | ORAL | 60 mg in 1 1 | 5/20/2021 | |
| Rebel Distributors Corp | 21695-336 | ORAL | 10 mg in 5 mL | 8/27/2009 | |
| A-S Medication Solutions | 50090-3011 | ORAL | 60 mg in 1 1 | 12/28/2023 | |
| Advanced Rx of Tennessee, LLC | 80425-0530 | ORAL | 60 mg in 1 1 | 6/2/2025 | |
| Rebel Distributors Corp. | 21695-243 | ORAL | 60 mg in 1 1 | 12/1/2009 | |
| Actavis Pharma, Inc. | 52544-082 | ORAL | 30 mg in 1 1 | 3/1/2021 | |
| Physicians Total Care, Inc. | 54868-0263 | ORAL | 10 mg in 5 mL | 12/9/2011 | |
| PAI Holdings, LLC | 0121-0504 | ORAL | 12 mg in 5 mL | 10/16/2023 | |
| RxChange Co. | 33358-001 | ORAL | 30 mg in 1 1 | 11/5/2014 | |
| NuCare Pharmaceuticals, Inc. | 68071-3061 | ORAL | 30 mg in 1 1 | 2/10/2021 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SUNSEDYL COUGH LINCTUS | SIN03490P | ELIXIR | 9 mg/5 ml | 6/26/1989 | |
| SUNSEDYL FORTE COUGH LINCTUS | SIN07750P | ELIXIR | 10.0 mg/5 ml | 6/21/1994 | |
| UNIDRYL CD EXPECTORANT | SIN02917P | SYRUP | 5mg/5ml | 5/22/1989 | |
| PHENEXPECT CD SYRUP | SIN06702P | SYRUP | 5.7 mg/5 ml | 12/3/1991 | |
| PARACETAMOL CODEINE TABLETS | SIN06330P | TABLET | 8 mg | 7/2/1991 | |
| CHLORSEDYL LINCTUS | SIN02933P | ELIXIR | 9 mg/5 ml | 5/22/1989 | |
| PACOFEN TABLETS | SIN06271P | TABLET | 8 mg | 5/7/1991 | |
| DHASEDYL SYRUP | SIN06928P | SYRUP | 9 mg/5 ml | 4/13/1992 | |
| COPHADYL-E COUGH LINCTUS | SIN09104P | ELIXIR | 9 mg/5 ml | 12/28/1996 | |
| PANACO TABLETS | SIN05462P | TABLET | 9 mg | 2/19/1991 |
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| CECOL COUGH SYRUP | N/A | N/A | N/A | 2/15/2019 | |
| MARSEDYL ELIXIR | N/A | N/A | N/A | 2/25/1984 | |
| PFC COUGH SYRUP CM FORMULA | N/A | N/A | N/A | 7/9/2010 | |
| COFFTIER COUGH SYRUP | N/A | N/A | N/A | 2/15/2008 | |
| COCURE COUGH SYRUP | N/A | N/A | N/A | 7/13/2001 | |
| UNI-CODPLEX SYRUP | N/A | N/A | N/A | 12/14/1998 | |
| DECOL COUGH SYRUP | N/A | N/A | N/A | 2/15/2019 | |
| ROYAL COUGH SYRUP | N/A | N/A | N/A | 7/8/2019 | |
| DIPHETAN COUGH SYRUP | N/A | N/A | N/A | 8/20/1986 | |
| THENADYL E C COMPOUND SYRUP | N/A | N/A | N/A | 5/3/1979 |
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
View More Health Canada Approvals
Sign in to access additional Health Canada approved drug information with detailed regulatory data.
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TEVA-COTRIDIN | teva canada limited | 02169126 | Syrup - Oral | 10 MG / 5 ML | 7/30/1996 |
| SUPPRESS COUGH SYR W.COD.DIPHEN.HCL AMM.CHL. | stanley pharmaceuticals, a division of vita health products inc. | 02190575 | Syrup - Oral | 3.3 MG / 5 ML | 12/31/1996 |
| ACETYLSALICYLIC ACID, CAFFEINE AND 8 MG CODEINE PHOSPHATE | cellchem pharmaceuticals inc. | 00095494 | Tablet - Oral | 8 MG | 12/31/1970 |
| ROBAXISAL C 1/4 | glaxosmithkline consumer healthcare ulc | 01934783 | Tablet - Oral | 16.2 MG | 12/31/1992 |
| PAINEX TAB 0.5GR | icn canada ltd. | 00295124 | Tablet - Oral | 30 MG / TAB | 12/31/1974 |
| ACETAMINOPHEN 325 MG CAFFEINE AND CODEINE | tanta pharmaceuticals inc | 02271834 | Tablet - Oral | 8 MG | N/A |
| TRIANAL C¼ | laboratoire riva inc. | 02242406 | Capsule - Oral | 15 MG | 12/22/2006 |
| NOVO-GESIC-C8 | novopharm limited | 00615528 | Tablet - Oral | 8 MG | 12/31/1985 |
| EXDOL-30 | 02232389 | Tablet - Oral | 30 MG | 9/1/1998 | |
| C2 BUFFERED WITH CODEINE TAB | wampole brands, a division of pangeo pharma (canada) inc. | 00693979 | Tablet - Oral | 8 MG | 12/31/1986 |
CIMA AEMPS Drug Approvals
View More CIMA AEMPS Approvals
Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
View More Philippines FDA Approvals
Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
View More Saudi SFDA Approvals
Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
View More Malaysia NPRA Approvals
Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
View More UK EMC Drug Information
Sign in to access additional UK EMC drug information with detailed pharmaceutical data.
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.