MedPath

Dextromethorphan

Generic Name
Dextromethorphan
Brand Names
Auvelity, Benylin DM, Bromfed DM, Broncotron, Cepacol Sore Throat Plus Cough, Cheracol D, Children's Nyquil Cold and Cough, Chloraseptic Sore Throat + Cough, Coricidin Hbp Chest Congestion, Coricidin Hbp Cough and Cold, Creomulsion, DM, Dayquil Cough, Delsym, Delsym Cough Plus Chest Congestion DM, Delsym Cough Plus Soothing Action, Delsym Cough Relief Plus Soothing Action, Despec Reformulated Jun 2008, Diabetic Tussin DM, Dimetapp Long Acting Cough Plus Cold, Diphen, G-zyncof, Mucinex Children's Cough, Mucinex Cough, Mucinex DM, Nuedexta, Nyquil Cough, Pediacare Children's Cough and Congestion, Promethazine DM, Robafen Cough, Robafen DM, Robitussin 12 Hour Cough Relief, Robitussin Cough & Congestion, Robitussin Maximum Strength Cough Plus Chest Congestion DM, Robitussin Nighttime Cough DM, Robitussin Pediatric Cough & Cold LA, Robitussin Pediatric Cough Suppressant, Safetussin DM, Safetussin PM, Scot-tussin DM, Scot-tussin Diabetic CF, Scot-tussin Sugar Free DM, Sudafed PE Children's Cold & Cough, Triaminic Day Time Cold & Cough, Tusnel Diabetic
Drug Type
Small Molecule
Chemical Formula
C18H25NO
CAS Number
125-71-3
Unique Ingredient Identifier
7355X3ROTS

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

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.

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