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Drug ReportsGuaifenesin
Guaifenesin
/ Guaifenesin, Flowtuss, Guaifenesin, Guaifenesin /, Hycofenix, Mucinex, Obredon, Xtrelus (guaifenesin) is a small molecule pharmaceutical. Guaifenesin was first approved as Mucinex on 2002-07-12. It is used to treat allergic rhinitis perennial, bronchitis, common cold, cough, and laryngitis amongst others in the USA.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
stomatognathic diseasesD009057
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Guaifenesin, Mucinex
Combinations
Guaifenesin dextromethorphan, Guaifenesin pseudoephedrine, Mucinex, Mucinex 12hr & fever multi-symptom, Mucinex d (discontinued: Flowtuss, Guaifenesin pseudoephedrine, Hycofenix, Obredon, Xtrelus)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Guaifenesin
+
Hydrocodone bitartrate
Tradename
Company
Number
Date
Products
FLOWTUSSChartwell PharmaceuticalsN-022424 DISCN2015-05-14
1 products
XTRELUSECI PharmaceuticalsN-208085 DISCN2018-04-25
1 products, RLD
OBREDONSovereign PharmaceuticalsN-205474 DISCN2014-11-14
1 products, RLD
Hide discontinued
Guaifenesin
+
Hydrocodone bitartrate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
HYCOFENIXChartwell PharmaceuticalsN-022279 DISCN2015-05-14
1 products, RLD
Hide discontinued
Dextromethorphan hydrobromide
+
Guaifenesin
Tradename
Company
Number
Date
Products
MUCINEX DMRB HealthN-021620 OTC2004-04-29
2 products, RLD
Guaifenesin
Tradename
Company
Number
Date
Products
MUCINEXRB HealthN-021282 OTC2002-07-12
2 products, RLD
Guaifenesin
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
MUCINEX DRB HealthN-021585 OTC2004-06-22
2 products, RLD, RS
Dextromethorphan hydrobromide
+
Guaifenesin
+
Naproxen sodium
Tradename
Company
Number
Date
Products
MUCINEX 12HR COLD & FEVER MULTI-SYMPTOMRB HealthN-217338 OTC2025-12-22
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
12 hour mucus reliefANDA2024-10-11
365 whole foods market guaifenesinANDA2026-01-20
7 selectC2002632025-07-18
acetaflu cough and chest congestionOTC monograph final2020-08-31
acetaminophen 500mg, dextromethorphan hbr 10mg, guaifenesin 200mg, phenylephrine hcl 5mgOTC monograph final2020-11-16
acetaminophen dextromethorphan hbr guaifenesin phenylephrine hclOTC monograph final2020-11-09
acetaminophen, dextromethorphan hbr ,guaifenesinC2002632026-01-20
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochlorideC2002632024-12-02
acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hclC2002632024-05-17
acetaminophen, guaifenesin, phenylephrine hcl and dextromethorphan hbrC2002632026-01-28
Show 1084 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sinusitisEFO_0007486D012852J32
whooping coughEFO_0000650D014917A37
bronchitis—D001991J40
cough—D003371R05
pharyngitis—D010612R07.0
common coldEFO_0007214D003139J00
allergic rhinitis perennialEFO_1001417D012221J30.89
laryngitis—D007827—
asthmaEFO_0000270D001249J45
postoperative pain—D010149G89.18
Show 13 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Guaifenesin / Hydrocodone Bitartrate, Obredon, Sovereign Pharms
95499072035-11-13DS, DPU-2023
98084312035-11-13DS, DPU-2023
101053242035-11-13DS, DPU-2023
ATC Codes
R: Respiratory system drugs
— R05: Cough and cold preparations
— R05C: Expectorants, excl. combinations with cough suppressants
— R05CA: Expectorants
— R05CA03: Guaifenesin
HCPCS
No data
Clinical
Clinical Trials
168 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544——4913934
CoughD003371—R052346520
Helicobacter infectionsD016481EFO_1000961——355416
Healthy volunteers/patients———14——1—15
Communicable diseasesD003141———182111
Respiratory tract infectionsD012141—J06.9—334—9
Type 2 diabetes mellitusD003924EFO_0001360E11—21215
BronchitisD001991—J40——1225
Diabetes mellitusD003920EFO_0000400E08-E13—113—4
Common coldD003139EFO_0007214J00—112—4
Show 36 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ulcerative colitisD003093EFO_0000729K51——3——3
ColitisD003092EFO_0003872K52.9——3——3
UlcerD014456MPATH_579———3——3
UveitisD014605EFO_1001231H20.9——2——2
Inflammatory bowel diseasesD015212EFO_0003767———2——2
Intestinal diseasesD007410—K63.9——2——2
PainD010146EFO_0003843R52——2——2
Postoperative painD010149—G89.18——1—12
Hemophilia bD002836—D67——1—12
Virus diseasesD014777—B34——1——1
Show 8 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577———1——34
InflammationD007249MP_0001845——1——12
Systemic lupus erythematosusD008180EFO_0002690M32—2———2
AtaxiaD001259—R27.012———2
Friedreich ataxiaD005621Orphanet_95G11.1112———2
Cerebellar ataxiaD002524——12———2
Kidney diseasesD007674EFO_0003086N0811——12
Amyotrophic lateral sclerosisD000690EFO_0000253G12.21—1———1
Motor neuron diseaseD016472EFO_0003782G12.2—1———1
SclerosisD012598———1———1
Show 61 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C802————2
Therapeutic equivalencyD013810——1————1
Non-small-cell lung carcinomaD002289——1————1
GlioblastomaD005909EFO_0000515—1————1
Mucociliary clearanceD009079——1————1
High-intensity focused ultrasound ablationD057086——1————1
Alzheimer diseaseD000544EFO_0000249F031————1
Low-level light therapyD028022——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung diseasesD008171EFO_0003818J98.4————22
Whooping coughD014917EFO_0000650A37————22
Irritable bowel syndromeD043183EFO_0000555K58————22
DiarrheaD003967—R19.7————22
ObesityD009765EFO_0001073E66.9————22
SchizophreniaD012559EFO_0000692F20————11
Psychotic disordersD011618—F20.81————11
PneumoniaD011014EFO_0003106J18————11
Sleep apnea syndromesD012891EFO_0003877G47.3————11
ApneaD001049—R06.81————11
Show 33 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGuaifenesin
INNguaifenesin
Description
Guaifenesin is a member of methoxybenzenes.
Classification
Small molecule
Drug classExpectorant
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1ccccc1OCC(O)CO
Identifiers
PDB—
CAS-ID93-14-1
RxCUI—
ChEMBL IDCHEMBL980
ChEBI ID—
PubChem CID3516
DrugBankDB00874
UNII ID495W7451VQ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
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Estimated US medical usage
Guaifenesin
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Pentoxyverine
Total medical expenditures per year (USD, in millions)
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Guaifenesin
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Pentoxyverine
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Phenylephrine
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Guaifenesin
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Chlophedianol
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Guaifenesin
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Phenylephrine
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Chlorpheniramine
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Guaifenesin
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Codeine
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Guaifenesin
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Codeine
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Phenylpropanolamine
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Guaifenesin
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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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Dyphylline
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Guaifenesin
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Ephedrine
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Guaifenesin
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Guaifenesin
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Hydrocodone
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Guaifenesin
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Phenylephrine
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Hydrocodone
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Guaifenesin
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Oxtriphylline
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Guaifenesin
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Phenylephrine
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Guaifenesin
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Phenylpropanolamine
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Guaifenesin
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Pseudoephedrine
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Guaifenesin
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Theophylline
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Tabular view
Trends
PubMed Central
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Additional graphs summarizing 1,574 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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22,607 adverse events reported
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