Overview
Dextromethorphan is a levorphanol derivative and codeine analog commonly used as a cough suppressant and also a drug of abuse. Although similar in structure to other opioids, it has minimal interaction with opioid receptors. Dextromethorphan was granted FDA approval before 3 December 1957.
Indication
Dextromethorphan is indicated in combination with brompheniramine and pseudoephedrine in the treatment of coughs and upper respiratory symptoms associated with allergies or the common cold. Dextromethorphan is also used in combination with guaifenesin as an over-the-counter product to relieve a cough. Dextromethorphan in combination with quinidine is indicated in the treatment of pseudobulbar affect.
Associated Conditions
- Allergic cough
- Common Cold
- Cough
- Cough caused by Common Cold
- Coughing caused by Allergies
- Coughing caused by Bronchitis
- Coughing caused by Flu caused by Influenza
- Fever
- Flu caused by Influenza
- Headache
- Irritative cough
- Itching of the nose
- Itching of the throat
- Major Depressive Disorder (MDD)
- Nasal Congestion
- Pseudobulbar Affect (PBA)
- Rhinorrhoea
- Sneezing
- Cold or flu syndrome
- Upper respiratory symptoms
- Watery itchy eyes
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/10/09 | Phase 1 | Active, not recruiting | Allyx Therapeutics | ||
2024/08/22 | Not Applicable | Not yet recruiting | |||
2024/04/25 | Phase 1 | Not yet recruiting | |||
2024/04/04 | Phase 1 | Not yet recruiting | Jemincare | ||
2024/01/22 | Not Applicable | Completed | Zulekha Hospitals | ||
2023/07/17 | Phase 1 | Completed | Drugs for Neglected Diseases | ||
2023/07/13 | Phase 4 | Completed | All India Institute of Medical Sciences, Bhubaneswar | ||
2023/01/26 | Phase 1 | Completed | |||
2022/11/02 | Phase 1 | Completed | |||
2022/10/21 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
BI-MART | 37835-525 | ORAL | 30 mg in 30 mL | 5/1/2025 | |
Wockhardt USA LLC. | 64679-604 | ORAL | 15 mg in 5 mL | 3/20/2023 | |
NUVICARE LLC | 84324-019 | ORAL | 15 mg in 1 1 | 5/20/2025 | |
Walgreen Company | 0363-8005 | ORAL | 20 mg in 20 mL | 4/25/2025 | |
Proficient Rx LP | 63187-930 | ORAL | 10 mg in 5 mL | 4/1/2022 | |
Publix Super Markets Inc | 56062-763 | ORAL | 20 mg in 30 mL | 5/19/2025 | |
OPMX LLC | 69729-069 | ORAL | 10 mg in 5 mL | 5/15/2025 | |
Meijer Distribution Inc | 41250-436 | ORAL | 30 mg in 1 1 | 5/7/2025 | |
Walmart | 79903-337 | ORAL | 10 mg in 1 1 | 6/9/2025 | |
CVS | 51316-662 | ORAL | 20 mg in 20 mL | 5/2/2025 |
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 |
---|---|---|---|---|---|
PAEDICOF SYRUP (Revised Formula) | SIN11515P | SYRUP | 5 mg/5 ml | 5/15/2001 | |
PUSIRAN TABLET 15 mg | ATLANTIC LABORATORIES CORPN LTD | SIN02726P | TABLET, SUGAR COATED | 15 mg | 5/5/1989 |
METOPHAN COUGH SYRUP 15 mg/5 ml | SIN08789P | SYRUP | 15 mg/5 ml | 7/3/1996 | |
COUGH-EN LINCTUS | SIN08780P | ELIXIR | 15 mg/5 ml | 7/3/1996 | |
BEATHORPHAN TABLETS 15 mg | SIN02653P | TABLET, FILM COATED | 15 mg | 4/27/1989 | |
SEDILIX-DM LINCTUS | SIN07865P | ELIXIR | 15 mg/5 ml | 10/6/1994 | |
MENDICOF SYRUP (Revised Formula) | SIN11516P | SYRUP | 15 mg/5 ml | 5/15/2001 | |
TUSSIDEX FORTE LINCTUS 15 mg/5 ml | SIN06770P | ELIXIR | 15 mg/5 ml | 1/21/1992 | |
DEXCOPHAN PAEDIATRIC LINCTUS 5.5 mg/5 ml | SIN03252P | ELIXIR | 5.5 mg/5 ml | 6/2/1989 | |
SUNTHORPHAN SYRUP 15MG/5ML | SIN13992P | SYRUP | 15mg/5ml | 7/29/2011 |
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 |
---|---|---|---|---|---|
NEW MARSEDYL-DM ELIXIR | N/A | N/A | N/A | 8/11/2015 | |
VIDA TUSSIN-DM SYRUP | N/A | N/A | N/A | 10/28/2008 | |
NEO-ROCODEX TUSSIN DM SYRUP | N/A | N/A | N/A | 5/29/2020 | |
WASEDYL SYRUP | N/A | N/A | N/A | 9/26/1997 | |
ANCOU TAB 15MG | N/A | N/A | N/A | 10/7/2004 | |
UNI-RAMINE D.E. SYRUP | N/A | N/A | N/A | 7/3/1998 | |
DEXSIN SYRUP | N/A | N/A | N/A | 6/26/2000 | |
MARSEDYL TAB | N/A | N/A | N/A | 4/17/1985 | |
DEXTROPHEN TAB 15MG | N/A | N/A | N/A | 7/30/1979 | |
GUSILON COUGH LINCTUS | N/A | karen laboratories o/b karen pharmaceutical co ltd | N/A | N/A | 5/17/1982 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
APOHEALTH CONGESTED COLD & COUGH RELIEF ELIXIR oral liquid bottle | 227533 | Medicine | A | 9/2/2014 | |
PRICELINE PHARMACY CONGESTED COLD & COUGH oral liquid bottle | 459288 | Medicine | A | 8/13/2024 | |
CODRAL DAY & NIGHT + DRY COUGH capsule blister pack | 121310 | Medicine | A | 10/5/2005 | |
DURO-TUSS DRY COUGH & COLD LIQUID NIGHT oral liquid bottle | 465432 | Medicine | A | 10/23/2024 | |
CHEMISTS' OWN COUGH, COLD & FLU DAY/NIGHT PE capsule blister pack | 289427 | Medicine | A | 5/29/2017 | |
BENADRYL COUGH MEDICINE FOR DRY COUGHS oral liquid bottle (reformulation) | 57233 | Medicine | A | 11/27/1996 | |
TRUST COLD & FLU + COUGH DAY & NIGHT CAPSULES blister pack | 300048 | Medicine | A | 2/26/2018 | |
CHEMISTS' OWN COUGH, COLD & FLU RELIEF PE capsules blister pack | 290004 | Medicine | A | 6/9/2017 | |
CODRAL DRY IRRITATING COUGH FORTE STRENGTH dextromethorphan hydrobromide monohydrate 3 mg/mL oral liquid bottle | 473727 | Medicine | A | 12/18/2024 | |
DURO-TUSS DRY COUGH PLUS SORE THROAT lozenge blister pack (lemon flavour) | 10102 | Medicine | A | 7/8/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ROBITUSSIN COUGH, COLD & FLU LIQUI-GELS | wyeth consumer healthcare inc. | 02161672 | Capsule - Oral | 10 MG | 12/31/1995 |
COLD MEDICATION REGULAR NIGHTTIME TABLETS | cellchem pharmaceuticals inc. | N/A | Tablet - Oral | 15 MG | N/A |
CALMYLIN COUGH AND FLU LIQ | technilab pharma inc. | 01978314 | Liquid - Oral | 15 MG / 15 ML | 12/31/1992 |
PULMORPHAN | laboratoire riva inc. | 00513741 | Syrup - Oral | 10 MG / 5 ML | 12/31/1978 |
ZICAM MULTI-SYMPTOM COLD & FLU DAYTIME | zicam llc | 02313316 | Liquid - Oral | 10 MG / 15 ML | 10/30/2008 |
DM COUGH SYRUP | tanta pharmaceuticals inc | 00833231 | Syrup - Oral | 15 MG / 5 ML | 12/31/1991 |
DM COUGH AND COLD LIQUID | tanta pharmaceuticals inc | 02267446 | Solution - Oral | 10.0 MG / 5 ML | 2/20/2007 |
A.M. COLD RELIEF FORMULA | ivax pharmaceuticals incorporated | 02262312 | Capsule - Oral | 15 MG | N/A |
DM COUGH AND COLD SYRUP | 02266466 | Syrup - Oral | 10 MG / 5 ML | 12/18/2006 | |
NYQUIL LIQUICAPS | procter & gamble inc | 01996215 | Capsule - Oral | 10 MG / CAP | 12/31/1993 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
FORMULATUS 7,33 mg PASTILLAS PARA CHUPAR SABOR MIEL | Laboratorios Vicks S.L. | 61392 | PASTILLA PARA CHUPAR | Sin Receta | Not Commercialized |
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. |
Help Us Improve
Your feedback helps us provide better drug information and insights.