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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/02 | Phase 4 | Recruiting | |||
2023/03/16 | Phase 4 | Completed | |||
2022/11/23 | Phase 3 | Completed | |||
2020/11/23 | Phase 3 | Completed | Brazilian Clinical Research Institute | ||
2018/12/21 | Phase 4 | Completed | |||
2018/03/27 | Not Applicable | Terminated | |||
2017/11/07 | Phase 1 | Completed | |||
2017/08/04 | Not Applicable | Completed | |||
2016/04/13 | Phase 1 | Completed | Michael Camilleri | ||
2015/12/09 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Northwind Pharmaceuticals, LLC | 51655-910 | ORAL | 30 mg in 1 1 | 6/14/2023 | |
| DIRECT RX | 61919-023 | ORAL | 30 mg in 1 1 | 3/29/2023 | |
| Physicians Total Care, Inc. | 54868-0378 | ORAL | 12 mg in 5 mL | 11/10/2010 | |
| Akorn | 50383-338 | ORAL | 24 mg in 10 mL | 5/25/2022 | |
| Nostrum Laboratories, Inc. | 70408-185 | ORAL | 10 mg in 5 mL | 12/11/2018 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0243 | ORAL | 15 mg in 1 1 | 3/15/2021 | |
| A-S Medication Solutions | 50090-5204 | ORAL | 60 mg in 1 1 | 5/20/2021 | |
| Direct_Rx | 72189-486 | ORAL | 10 mg in 5 mL | 6/2/2023 | |
| Blenheim Pharmacal, Inc. | 10544-100 | ORAL | 30 mg in 1 1 | 12/31/2013 | |
| REMEDYREPACK INC. | 70518-2764 | ORAL | 60 mg in 1 1 | 3/6/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Linctus Tussis Rubra 10mg/5ml | SIN06870P | ELIXIR | 10 mg/5 ml | 3/4/1992 | |
| CODEINE TABLETS 30 mg | SIN07044P | TABLET | 30 mg | 6/3/1992 | |
| PROMELIX SYRUP | SIN06423P | SYRUP | 9 mg/5 ml | 7/8/1991 | |
| PROCODIN SYRUP | SIN04075P | SYRUP | 9 mg/5 ml | 3/28/1990 | |
| UNISEDYL FORTE LINCTUS | SIN02919P | ELIXIR | 10 mg/5 ml | 5/22/1989 | |
| BEACTAFED CO SYRUP | SIN03140P | SYRUP | 10 mg/5 ml | 5/30/1989 | |
| COLINCTUS 10 MIXTURE 10 mg/5 ml | SIN03413P | ELIXIR | 10 mg/5 ml | 6/22/1989 | |
| COPHADYL COUGH LINCTUS | SIN09071P | ELIXIR | 9 mg/5 ml | 12/14/1996 | |
| L.T.R. COUGH LINCTUS 10 mg/5 ml | SIN03699P | ELIXIR | 10 mg/5 ml | 8/5/1989 | |
| FEDAC COMPOUND LINCTUS | SIN03195P | ELIXIR | 10 mg/5 ml | 6/1/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PROSEDYL COUGH SYRUP | N/A | N/A | N/A | 8/20/1985 | |
| MOTRACK COUGH SYRUP | N/A | N/A | N/A | 9/14/2010 | |
| MERSIDYL SYRUP | N/A | N/A | N/A | 2/25/1986 | |
| NICE PHENDYL-B LINCTUS | N/A | N/A | N/A | 7/15/1982 | |
| NEODINE TAB | N/A | N/A | N/A | 1/11/2002 | |
| COCLEAN SYRUP | N/A | N/A | N/A | 6/15/2001 | |
| PECOLIN SYRUP | N/A | N/A | N/A | 3/9/1992 | |
| OROSEDYL COUGH SYRUP | N/A | N/A | N/A | 2/8/2019 | |
| SUPHENIN SYRUP | N/A | N/A | N/A | 3/28/2001 | |
| PACTOREX SYRUP | N/A | N/A | N/A | 4/20/1979 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PRACET 30 | laboratoire riva inc. | 02290359 | Tablet - Oral | 30 MG | N/A |
| 222 TABLETS | mcneil consumer healthcare division of johnson & johnson inc | 00108162 | Tablet - Oral | 8 MG | 12/31/1951 |
| ATASOL 30 | church & dwight canada corp | 00293512 | Tablet - Oral | 30 MG | 12/31/1975 |
| ATASOL 15 | church & dwight canada corp | 00293504 | Tablet - Oral | 15 MG | 12/31/1975 |
| (EXTRA STRENGTH) ACETAMINOPHEN, CAFFEINE & 8MG CODEINE PHOSPHATE CAPLETS | stanley pharmaceuticals, a division of vita health products inc. | 02236871 | Tablet - Oral | 8 MG | 7/22/1998 |
| AXISAL-C1/8 | technilab pharma inc. | 02237997 | Tablet - Oral | 8 MG | N/A |
| BENYLIN 2 COLD AND FLU WITH CODEINE | mcneil consumer healthcare division of johnson & johnson inc | 02245709 | Syrup - Oral | 3.3 MG / 5 ML | 7/11/2003 |
| COTRIFED | technilab pharma inc. | 00809144 | Liquid - Oral | 10 MG / 5 ML | 12/31/1989 |
| TYLENOL WITH CODEINE ELIXIR | mcneil pharmaceutical, division of ortho-mcneil inc. | 00685143 | Elixir - Oral | 8 MG / 5 ML | 12/31/1986 |
| AMBENYL COUGH SYRUP | parke-davis division, warner-lambert canada inc. | 00469122 | Liquid - Oral | 10 MG / 5 ML | 12/31/1979 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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