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Chlor-trimeton, Aerinaze(pseudoephedrine)
Actahist, Actifed, Advil, Aerinaze, Afrinol, Aleve, Allegr, Allerfed, Benylin, Bromanate, Bromfed-dm, Brompheril, Chlor-trimeton, Clarinex, Claritin, Codimal-l.a, Corphed, Dimetane-dx, Disobrom, Disophrol, Drixoral, Histafed, Hycofenix, Ibuprohm, Isoclor, Motrin, Mucinex D, Myfed, Resporal, Rezira, Semprex, Sine-aid, Sudafed, Tavist, Trilitron, Trinalin, Triphed, Zutripro, Zyrtec (pseudoephedrine) is a small molecule pharmaceutical. Pseudoephedrine was first approved as Chlor-trimeton on 1982-01-01. It is used to treat allergic rhinitis perennial, asthma, common cold, and sinusitis in the USA. It has been approved in Europe to treat allergic rhinitis seasonal.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
immune system diseasesD007154
Trade Name
FDA
EMA
Sudafed (generic drugs available since 1985-03-22, discontinued: Afrinol, Novafed)
Combinations
Advil, Allegr, Clarinex, Claritin, Ibuprohm, Motrin, Mucinex d, Sine-aid, Zyrtec (generic drugs available since 1985-03-22, discontinued: Actahist, Actifed, Aleve, Allerfed, Benylin, Bromanate, Bromfed-dm, Brompheril, Chlor-trimeton, Clarinex d, Codimal-l.a., Corphed, Dimetane-dx, Disobrom, Disophrol, Drixoral, Histafed, Hycofenix, Isoclor, Myfed, Resporal, Rezira, Semprex, Tavist, Trilitron, Trinalin, Triphed, Zutripro)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Acetaminophen
+
Clemastine fumarate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
TAVIST ALLERGY/SINUS/HEADACHENovartisN-021082 DISCN2001-03-01
1 products
Hide discontinued
Acetaminophen
+
Dexbrompheniramine maleate
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
DRIXORAL PLUSMerck Sharp & DohmeN-019453 DISCN1987-05-22
1 products
Hide discontinued
Acrivastine
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
SEMPREX-DAuxilium PharmaceuticalsN-019806 DISCN1994-03-25
1 products, RLD
Hide discontinued
Azatadine maleate
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
TRINALINMerck Sharp & DohmeN-018506 DISCN1982-03-23
1 products
Hide discontinued
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
Brompheniramine maleate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATEAlzaN-019672 DISCN1996-03-29
1 products
Hide discontinued
Cetirizine hydrochloride
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ZYRTEC-D 12 HOURJohnson & JohnsonN-021150 OTC2007-11-09
1 products, RLD, RS
Chlorpheniramine maleate
+
Hydrocodone bitartrate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ZUTRIPROPersion PharmaceuticalsN-022439 DISCN2011-06-08
1 products, RLD
Hide discontinued
Chlorpheniramine maleate
+
Ibuprofen
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL ALLERGY SINUSGSKN-021441 OTC2002-12-19
1 products, RLD, RS
CHILDREN'S ADVIL ALLERGY SINUSGSKN-021587 OTC2004-02-24
1 products, RLD, RS
Chlorpheniramine maleate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATECentral PharmaceuticalsN-019428 DISCN1988-08-02
1 products
ISOCLORFisonsN-018747 DISCN1986-03-06
1 products
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATEGRAHAM DMN-018843 DISCN1985-03-18
1 products
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATEGRAHAM DMN-018844 DISCN1985-03-20
1 products
CODIMAL-L.A. 12Schwarz PharmaN-018935 DISCN1985-04-15
1 products
Hide discontinued
Chlorpheniramine maleate
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
CHLOR-TRIMETONBayerN-018397 DISCN1982-01-01
1 products, RLD
Hide discontinued
Codeine phosphate
+
Pseudoephedrine hydrochloride
+
Triprolidine hydrochloride
Tradename
Company
Number
Date
Products
ACTIFED W/ CODEINEGSKN-012575 DISCN1984-04-04
1 products
Hide discontinued
Desloratadine
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
CLARINEX-D 12 HOUROrganonN-021313 RX2006-02-01
1 products, RLD, RS
Show 1 discontinued
Dexbrompheniramine maleate
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
DISOPHROLMerck Sharp & DohmeN-012394 DISCN1982-01-01
1 products
DRIXORALMerck Sharp & DohmeN-013483 DISCN1982-09-13
1 products, RLD
DISOPHROLMerck Sharp & DohmeN-013483 DISCN1982-09-13
1 products
Hide discontinued
Diphenhydramine hydrochloride
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
BENYLINPfizerN-019014 DISCN1985-06-11
1 products
Hide discontinued
Fexofenadine hydrochloride
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONSanofiN-020786 OTC2011-01-24
1 products, RLD, RS
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTIONSanofiN-021704 OTC2011-01-24
1 products, RLD, RS
Guaifenesin
+
Hydrocodone bitartrate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
HYCOFENIXChartwell PharmaceuticalsN-022279 DISCN2015-05-14
1 products, RLD
Hide discontinued
Guaifenesin
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
MUCINEX DRB HealthN-021585 OTC2004-06-22
2 products, RLD, RS
Hydrocodone bitartrate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
REZIRAPersion PharmaceuticalsN-022442 DISCN2011-06-08
1 products, RLD
Hide discontinued
Ibuprofen
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL COLD AND SINUSGSKN-019771 OTC1989-09-19
1 products, RLD, RS
CHILDREN'S ADVIL COLDGSKN-021373 OTC2002-04-18
1 products
ADVIL COLD AND SINUSGSKN-021374 OTC2002-05-30
1 products, RLD, RS
SINE-AID IBJohnson & JohnsonN-019899 OTC1992-12-31
1 products
CHILDREN'S MOTRIN COLDJohnson & JohnsonN-021128 OTC2000-08-01
1 products, RLD, RS
Loratadine
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
CLARITIN-DBayerN-019670 OTC2002-11-27
1 products, RLD, RS
CLARITIN-D 24 HOURBayerN-020470 OTC2002-11-27
1 products, RLD, RS
Naproxen sodium
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ALEVE-D SINUS & COLDBayerN-021076 DISCN1999-11-29
1 products, RLD
Hide discontinued
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
SUDAFED 24 HOURJohnson & JohnsonN-020021 OTC1992-12-15
1 products, RLD, RS
Show 2 discontinued
Pseudoephedrine hydrochloride
+
Triprolidine hydrochloride
Tradename
Company
Number
Date
Products
ACTIFEDGSKN-018996 DISCN1985-06-17
1 products
Hide discontinued
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
AFRINOLMerck Sharp & DohmeN-018191 DISCN1982-01-01
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
advil dual action with acetaminophenNew Drug Application2023-04-13
allegra hives 24hrNew Drug Application2023-04-10
bayer aleveNew Drug Application2023-03-20
childrens zyrtec allergyNew Drug Application2023-06-06
clarinex-d 12 hourNew Drug Application2022-11-14
claritinANDA2023-05-24
corphedraNew Drug Application2019-12-05
leader allergy relief dANDA2023-06-15
motrin ibANDA2023-05-18
mucinex fast-max day cold and flu and night cold and fluOTC monograph final2023-06-15
Show 3 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic rhinitis perennialEFO_1001417D012221J30.89
asthmaEFO_0000270D001249J45
common coldEFO_0007214D003139J00
sinusitisEFO_0007486D012852J32
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Chlorpheniramine Maleate / Ibuprofen / Pseudoephedrine Hydrochloride, Advil Allergy Sinus, Glaxosmithkline
78632872027-02-28DP
Chlorpheniramine Maleate / Ibuprofen / Pseudoephedrine Hydrochloride, Children'S Advil Allergy Sinus, Glaxosmithkline
102386402024-05-25DP
ATC Codes
R: Respiratory system drugs
— R01: Nasal preparations
— R01B: Nasal decongestants for systemic use
— R01BA: Sympathomimetics
— R01BA02: Pseudoephedrine
— R01BA52: Pseudoephedrine, combinations
HCPCS
No data
Clinical
Clinical Trials
1337 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—9731518123
PainD010146EFO_0003843R521721303017113
Postoperative painD010149G89.184918271471
Allergic rhinitis seasonalD006255EFO_0003956J30181814647
OsteoarthritisD010003EFO_0002506M15-M1998164440
Patent ductus arteriosusD004374HP_0001643Q25.0291091239
Migraine disordersD008881EFO_0003821G43121610635
Low back painD017116HP_0003419M54.5—8614228
Knee osteoarthritisD020370EFO_0004616M1751135528
Allergic rhinitisD065631J30.9171010—28
Show 144 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80323—210
ArthritisD001168EFO_0005856M05-M143—3—17
Breast neoplasmsD001943EFO_0003869C50112—26
DermatitisD003872HP_0011123L30.91—4——5
Treatment-resistant depressive disorderD061218131——4
Rett syndromeD015518F84.2—21—14
Hiv infectionsD015658EFO_0000764B20—11—24
TuberculosisD014376EFO_0000774A15-A19—31——3
Local anesthesiaD000772—21—13
Atopic dermatitisD003876EFO_0000274L201—2——3
Show 72 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperalgesiaD00693012——14
ContraceptionD003267—1——34
MalariaD008288EFO_0001068B5422———3
Spinal cord injuriesD013119EFO_100191912———3
Soft tissue injuriesD017695—2——13
MelanomaD00854521———2
PhimosisD010688EFO_1001104N47.111———2
ParaphimosisD010263EFO_1001086N47.211———2
BalanitisD001446EFO_1000833N48.111———2
Retinopathy of prematurityD012178EFO_1001158H35.1—1——12
Show 58 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD0138108————8
Drug interactionsD0043474———15
PharmacokineticsD0105994———15
Pure autonomic failureD0549702————2
Food-drug interactionsD0185652————2
Shy-drager syndromeD012791EFO_10010502————2
Orthostatic hypotensionD007024I95.11————1
FastingD005215EFO_00027561————1
Mitochondrial diseasesD028361EFO_00005911————1
Hematologic neoplasmsD0193371————1
Show 19 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cystic fibrosisD003550EFO_0000390E84————33
HemorrhageD006470MP_0001914R58————22
Leg ulcerD007871————22
Blood pressureD001794EFO_0004325————22
Carotid endarterectomyD016894————22
Colonic neoplasmsD003110C18————11
HemostasisD006487————11
Urinary calculiD014545N20.9————11
Attention deficit disorder with hyperactivityD001289EFO_0003888F90————11
Pituitary dwarfismD004393EFO_1001109E23.0————11
Show 65 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePSEUDOEPHEDRINE
INNpseudoephedrine
Description
Pseudoephedrine is a member of the class of the class of phenylethanolamines that is (1S)-2-(methylamino)-1-phenylethan-1-ol in which the pro-S hydrogen at position 2 is replaced by a methyl group. It has a role as a sympathomimetic agent, an anti-asthmatic drug, a bronchodilator agent, a vasoconstrictor agent, a central nervous system drug, a nasal decongestant, a xenobiotic and a plant metabolite. It is a secondary alcohol, a secondary amino compound and a member of phenylethanolamines. It is a conjugate base of a pseudoephedrine(1+).
Classification
Small molecule
Drug classsympathomimetics
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN[C@@H](C)[C@@H](O)c1ccccc1
Identifiers
PDB—
CAS-ID90-82-4
RxCUI8896
ChEMBL IDCHEMBL1590
ChEBI ID51209
PubChem CID7028
DrugBankDB00852
UNII ID7CUC9DDI9F (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Clarinex - Organon
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,823 documents
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Safety
Black-box Warning
Black-box warning for: Triacin-c
Adverse Events
Top Adverse Reactions
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726 adverse events reported
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