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Drug ReportsDiphenhydramine
Diphenhydramine
Advil, Aleve, Benylin, Diphenhydramine, Diphenhydramine / (diphenhydramine) is a small molecule pharmaceutical. Diphenhydramine was first approved as Benadryl on 1982-01-01. It is used to treat allergic rhinitis perennial, anxiety disorders, motion sickness, nausea, and sleep initiation and maintenance disorders amongst others in the USA. The pharmaceutical is active against histamine H1 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
nervous system diseasesD009422
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
mental disordersD001523
circulatory and respiratory physiological phenomenaD002943
Trade Name
FDA
EMA
Diphenhydramine (discontinued: Antitussive, Beldin, Belix, Benadryl, Benylin, Diphenhydramine, Hydramine, Silphen, Vicks)
Combinations
Advil, Aleve, Ibuprofen diphenhydramine, Naproxen diphenhydramine (discontinued: Benylin, Naproxen diphenhydramine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Diphenhydramine hydrochloride
+
Ibuprofen
Tradename
Company
Number
Date
Products
ADVIL PMGSKN-021393 OTC2005-12-21
1 products, RLD, RS
Diphenhydramine citrate
+
Ibuprofen
Tradename
Company
Number
Date
Products
ADVIL PMGSKN-021394 OTC2005-12-21
1 products, RLD, RS
Diphenhydramine hydrochloride
+
Naproxen sodium
Tradename
Company
Number
Date
Products
ALEVE PMBayerN-205352 OTC2014-01-17
1 products, RLD, RS
Diphenhydramine hydrochloride
Tradename
Company
Number
Date
Products
BENADRYLMcNeil PharmaceuticalN-005845 DISCN1982-01-01
3 products
BENADRYLMcNeil PharmaceuticalN-006146 DISCN1982-01-01
2 products, RLD
BENADRYL PRESERVATIVE FREEMcNeil PharmaceuticalN-009486 DISCN1982-01-01
1 products, RLD
BENYLINPfizerN-006514 DISCN1982-01-01
1 products
Hide discontinued
Diphenhydramine hydrochloride
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
BENYLINPfizerN-019014 DISCN1985-06-11
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
24 / 7 life extra strength pain reliever pmC2002632024-10-30
24/7 life allergy reliefC2002632024-12-30
acetadrylOTC monograph not final2013-11-12
acetaflu nighttimeOTC monograph final2020-03-26
acetaflu nighttime effervescentOTC monograph final2020-03-26
acetamax pmOTC monograph not final2020-08-31
acetaminophen 500mg diphenhydramine hcl 25mgOTC monograph not final2020-11-16
acetaminophen and diphenhydramine hclC2002632024-12-16
acetaminophen and diphenhydramine hydrochlorideC2002632025-07-02
acetaminophen diphenhydramine hclC2002632024-12-19
Show 638 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
nausea—D009325R11.0
sleep initiation and maintenance disorders—D007319F51.01
allergic rhinitis perennialEFO_1001417D012221J30.89
urticariaEFO_0005531D014581L50
motion sickness—D009041T75.3
sneezingEFO_0004290D012912R06.7
anxiety disordersEFO_0006788D001008F41.1
juvenile arthritisEFO_1002007D001171M08
menorrhagiaEFO_0003945D008595N92.0
ankylosing spondylitisEFO_0003898D013167M45
Show 15 more
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D04: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04A: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04AA: Antihistamines for topical use
— D04AA32: Diphenhydramine
— D04AA33: Diphenhydramine methylbromide
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AA: Aminoalkyl ethers, systemic antihistamines
— R06AA02: Diphenhydramine
— R06AA52: Diphenhydramine, combinations
HCPCS
Code
Description
J1200
Injection, diphenhydramine hcl, up to 50 mg
Q0163
Diphenhydramine hydrochloride, 50 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at time of chemotherapy treatment not to exceed a 48 hour dosage regimen
Clinical
Clinical Trials
1543 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I1026289510864315
Healthy volunteers/patients———10521420131
Essential hypertensionD000075222—I10442114750
InfectionsD007239EFO_0000544—3912131145
Type 2 diabetes mellitusD003924EFO_0001360E1145915738
Kidney diseasesD007674EFO_0003086N08481213438
Covid-19D000086382—U07.151493229
SyndromeD013577——21057629
Diabetes mellitusD003920EFO_0000400E08-E1326513428
CoughD003371—R054565828
Show 209 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8014142—332
LymphomaD008223—C85.912162—129
LeukemiaD007938—C9513121—226
Multiple myelomaD009101—C90.08134—124
Plasma cell neoplasmsD054219——6104—120
Non-hodgkin lymphomaD008228—C85.98111—119
Breast neoplasmsD001943EFO_0003869C50582—316
Non-small-cell lung carcinomaD002289——555—115
HyperlipidemiasD006949EFO_0003774E78.5815——14
Lung neoplasmsD008175—C34.90472—111
Show 137 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.087——115
B-cell lymphomaD016393——74———11
Pancreatic neoplasmsD010190EFO_0003860C2545——110
Myeloid leukemia acuteD015470—C92.064———9
Hematologic neoplasmsD019337——26——19
B-cell chronic lymphocytic leukemiaD015451—C91.163———9
Hodgkin diseaseD006689—C8164———9
NeuralgiaD009437EFO_0009430——8——19
FibrosisD005355——37———8
Lymphoid leukemiaD007945—C9152——18
Show 224 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD004347——12———315
Drug-related side effects and adverse reactionsD064420—T88.72———35
Therapeutic equivalencyD013810——4————4
MalnutritionD044342EFO_0008572E40-E463———14
Chronic painD059350——1———34
Pure autonomic failureD054970——3————3
Pre-eclampsiaD011225EFO_0000668O141———12
Peripheral arterial diseaseD058729EFO_0004265—1———12
Autonomic nervous system diseasesD001342EFO_0009532G902————2
Food-drug interactionsD018565——2————2
Show 67 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ParasomniasD020447—G47.5————44
DyssomniasD020920——————33
Inferior wall myocardial infarctionD056989EFO_1000983—————22
Arteriovenous fistulaD001164—Q27.3————22
Suicidal ideationD059020EFO_0004320R45.851————22
Rotator cuff injuriesD000070636—M75.1————22
Lung diseasesD008171EFO_0003818J98.4————22
Whooping coughD014917EFO_0000650A37————22
DiarrheaD003967—R19.7————22
Systolic heart failureD054143EFO_1001207I50.20————11
Show 92 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDiphenhydramine
INNdiphenhydramine
Description
Diphenhydramine is an ether that is the benzhydryl ether of 2-(dimethylamino)ethanol. It is a H1-receptor antagonist used as a antipruritic and antitussive drug. It has a role as a H1-receptor antagonist, an antiemetic, a sedative, an anti-allergic agent, a muscarinic antagonist, an antiparkinson drug, an antipruritic drug, a local anaesthetic, an antidyskinesia agent, an antitussive and a oneirogen. It is an ether and a tertiary amino compound.
Classification
Small molecule
Drug classfirst-generation antihistamine (ethanolamine), anticholinergic, hallucinogen (deliriant)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN(C)CCOC(c1ccccc1)c1ccccc1
Identifiers
PDB—
CAS-ID58-73-1
RxCUI—
ChEMBL IDCHEMBL657
ChEBI ID4636
PubChem CID3100
DrugBankDB01075
UNII ID8GTS82S83M (ChemIDplus, GSRS)
Target
Agency Approved
HRH1
HRH1
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
3269
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Q6P9E5
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Diphenhydramine
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 19,433 documents
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Safety
Black-box Warning
Black-box warning for: Theraflu expressmax daytime nighttime value pack
Adverse Events
Top Adverse Reactions
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46,066 adverse events reported
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