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Drug ReportsDextromethorphan
Delsym, Nuedexta(dextromethorphan)
/ Dextromethorphan /, Auvelity, Bromfed-dm, Dextromethorphan /, Mucinex, Nuedexta (dextromethorphan) is a small molecule pharmaceutical. Dextromethorphan was first approved as Promethazine hydrochloride and dextromethorphan hydrobromide on 1984-04-02. It is used to treat cough in the USA. It has been approved in Europe to treat neurobehavioral manifestations.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
behavior and behavior mechanismsD001520
Trade Name
FDA
EMA
Delsym, Dextromethorphan polistirex
Combinations
Auvelity, Bromfed-dm, Brompheniramine maleate, pseudoephedrine dextromethorphan, Dextromethorphan quinidine, Guaifenesin dextromethorphan, Mucinex, Nuedexta, Promethazine, Promethazine dextromethorphan, Promethazine w/ dextromethorphan (discontinued: Bromanate, Bromfed-dm, Brompheniramine maleate, pseudoephedrine dextromethorphan, Dimetane-dx, Pherazine, Promethazine dextromethorphan)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dextromethorphan hydrobromide
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEANI PharmaceuticalsN-011265 RX1984-04-02
1 products, RLD
Brompheniramine maleate
+
Dextromethorphan hydrobromide
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
DIMETANE-DXA.H. Robins CompanyN-019279 DISCN1984-08-24
1 products, RLD
Hide discontinued
Dextromethorphan hydrobromide
+
Quinidine sulfate
Tradename
Company
Number
Date
Products
NUEDEXTAAvanir PharmaceuticalsN-021879 RX2010-10-29
1 products, RLD, RS
Dextromethorphan hydrobromide
+
Guaifenesin
Tradename
Company
Number
Date
Products
MUCINEX DMRB HealthN-021620 OTC2004-04-29
2 products, RLD
Bupropion hydrochloride
+
Dextromethorphan hydrobromide
Tradename
Company
Number
Date
Products
AUVELITYAxsome TherapeuticsN-215430 RX2022-08-18
1 products, RLD, RS
Dextromethorphan polistirex
Tradename
Company
Number
Date
Products
DELSYMRB HealthN-018658 OTC1982-10-08
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
auvelityNew Drug Application2024-09-18
childrens delsymC2002632024-12-18
childrens delsym cough plus chest congestion dm and delsym cough plus cold night timeC2002632024-12-18
childrens mucinexOTC monograph final2018-12-10
childrens mucinex chest congestionOTC monograph final2012-11-09
childrens mucinex coughOTC monograph final2012-11-09
childrens mucinex multi symptom cold and childrens mucinex night time multi symptom coldOTC monograph final2023-02-15
childrens mucinex multi-symptom coldC2002632023-10-17
delsymC2002632024-12-23
delsym (dextromethorphan)New Drug Application2024-04-08
Show 65 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sinusitisEFO_0007486D012852J32
asthmaEFO_0000270D001249J45
cough—D003371R05
common coldEFO_0007214D003139J00
allergic rhinitis perennialEFO_1001417D012221J30.89
urticariaEFO_0005531D014581L50
vasomotor rhinitisEFO_0007533D012223J30.0
whooping coughEFO_0000650D014917A37
bronchitis—D001991J40
pharyngitis—D010612R07.0
Show 14 more
Agency Specific
FDA
EMA
Expiration
Code
BUPROPION HYDROCHLORIDE / DEXTROMETHORPHAN HYDROBROMIDE, AUVELITY, AXSOME
2025-08-18NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Bupropion Hydrochloride / Dextromethorphan Hydrobromide, Auvelity, Axsome
107800642040-01-07U-3419
109258422040-01-07U-3419
109401242040-01-07U-3419
109669422040-01-07U-3419
107800662034-11-09U-3419
91682342034-11-05U-3419
91989052034-11-05U-3419
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92780952034-11-05U-3419
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94747312034-11-05U-3419
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97005282034-11-05U-3419
97005532034-11-05U-3419
97071912034-11-05U-3419
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114977212034-11-05U-3419
115109182034-11-05U-3419
115175422034-11-05U-3419
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115344142034-11-05DPU-3419
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116177472034-11-05U-3563
85693282033-10-29DPU-3419
Dextromethorphan Hydrobromide / Quinidine Sulfate, Nuedexta, Avanir Pharms
76592822026-08-13U-1093
82274842023-07-17U-1093
ATC Codes
N: Nervous system drugs
— N07: Other nervous system drugs in atc
— N07X: Other nervous system drugs in atc
— N07XX: Other nervous system drugs in atc
— N07XX59: Dextromethorphan, combinations
R: Respiratory system drugs
— R05: Cough and cold preparations
— R05D: Cough suppressants, excl. combinations with expectorants
— R05DA: Opium alkaloids and derivatives, cough suppressants
— R05DA09: Dextromethorphan
HCPCS
No data
Clinical
Clinical Trials
1976 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
BlepharitisD001762EFO_0009536H01.0——3——3
ConjunctivitisD003231—H10——2——2
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDextromethorphan
INNdextromethorphan
Description
Dextromethorphan is a 6-methoxy-11-methyl-1,3,4,9,10,10a-hexahydro-2H-10,4a-(epiminoethano)phenanthrene in which the sterocenters at positions 4a, 10 and 10a have S-configuration. It is a prodrug of dextrorphan and used as an antitussive drug for suppressing cough. It has a role as a NMDA receptor antagonist, a neurotoxin, a xenobiotic, an environmental contaminant, an antitussive, a prodrug and a oneirogen. It is functionally related to a dextrorphan. It is an enantiomer of a levomethorphan.
Classification
Small molecule
Drug classdeuterated compounds; narcotic antagonists/agonists (morphinan derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1ccc2c(c1)[C@]13CCCC[C@@H]1[C@H](C2)N(C)CC3
Identifiers
PDB—
CAS-ID125-71-3
RxCUI—
ChEMBL IDCHEMBL52440
ChEBI ID—
PubChem CID5360696
DrugBankDB00514
UNII ID7355X3ROTS (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Dextromethorphan
+
Acetaminophen
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Dextromethorphan
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Acetaminophen
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Doxylamine
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Dextromethorphan
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Phenylephrine
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Carbinoxamine
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Dextromethorphan
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Chlorpheniramine
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Dextromethorphan
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Doxylamine
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Dextromethorphan
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Guaifenesin
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Dextromethorphan
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Phenylephrine
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Guaifenesin
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Dextromethorphan
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Phenylephrine
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Dextromethorphan
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Phenylephrine
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Pyrilamine
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Dextromethorphan
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Phenylephrine
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Triprolidine
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Dextromethorphan
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Phenylpropanolamine
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Dextromethorphan
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Promethazine
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Dextromethorphan
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Pseudoephedrine
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Dextromethorphan
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Pyrilamine
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Dextromethorphan
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Quinidine
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PubMed Central
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Additional graphs summarizing 39,905 documents
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Safety
Black-box Warning
Black-box warning for: Auvelity
Adverse Events
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394,162 adverse events reported
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