Diphenhydramine - PharmaKB

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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Therapeutic Areas

Therapeutic Area	MeSH
respiratory tract diseases	D012140
otorhinolaryngologic diseases	D010038
nervous system diseases	D009422
skin and connective tissue diseases	D017437
immune system diseases	D007154
signs and symptoms pathological conditions	D013568
mental disorders	D001523
circulatory and respiratory physiological phenomena	D002943

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)

Abbreviated New Drug Application (ANDA)

Diphenhydramine hydrochloride

Ibuprofen

Tradename	Company	Number	Date	Products
ADVIL PM	GSK	N-021393 OTC	2005-12-21	1 products, RLD, RS

Diphenhydramine citrate

Ibuprofen

Tradename	Company	Number	Date	Products
ADVIL PM	GSK	N-021394 OTC	2005-12-21	1 products, RLD, RS

Diphenhydramine hydrochloride

Naproxen sodium

Tradename	Company	Number	Date	Products
ALEVE PM	Bayer	N-205352 OTC	2014-01-17	1 products, RLD, RS

Diphenhydramine hydrochloride

Tradename	Company	Number	Date	Products
BENADRYL	McNeil Pharmaceutical	N-005845 DISCN	1982-01-01	3 products
BENADRYL	McNeil Pharmaceutical	N-006146 DISCN	1982-01-01	2 products, RLD
BENADRYL PRESERVATIVE FREE	McNeil Pharmaceutical	N-009486 DISCN	1982-01-01	1 products, RLD
BENYLIN	Pfizer	N-006514 DISCN	1982-01-01	1 products

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Diphenhydramine hydrochloride

Pseudoephedrine hydrochloride

Tradename	Company	Number	Date	Products
BENYLIN	Pfizer	N-019014 DISCN	1985-06-11	1 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
acetadryl	OTC monograph not final	2013-11-12
acetaflu nighttime	OTC monograph final	2020-03-26
acetaflu nighttime effervescent	OTC monograph final	2020-03-26
acetamax pm	OTC monograph not final	2020-08-31
acetaminophen 500mg diphenhydramine hcl 25mg	OTC monograph not final	2020-11-16
acetaminophen and diphenhydramine citrate	C200263	2025-10-02
acetaminophen and diphenhydramine hcl	C200263	2025-12-19
acetaminophen and diphenhydramine hydrochloride	C200263	2025-07-02
acetaminophen diphenhydramine hcl	C200263	2025-12-22
acetaminophen liquid / acetaminophen diphenhydramine hcl liquid	C200263	2025-10-09

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
nausea	—	D009325	R11.0
sleep initiation and maintenance disorders	—	D007319	F51.01
allergic rhinitis perennial	EFO_1001417	D012221	J30.89
urticaria	EFO_0005531	D014581	L50
motion sickness	—	D009041	T75.3
sneezing	EFO_0004290	D012912	R06.7
anxiety disorders	EFO_0006788	D001008	F41.1
juvenile arthritis	EFO_1002007	D001171	M08
menorrhagia	EFO_0003945	D008595	N92.0
ankylosing spondylitis	EFO_0003898	D013167	M45

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Agency Specific

FDA

EMA

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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

1566 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypertension	D006973	EFO_0000537	I10	—	—	1	4	8	13
Altitude sickness	D000532	EFO_1000782	T70.29	—	—	—	1	—	1
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	—	—	1	—	1
Stroke	D020521	EFO_0000712	I63.9	—	—	—	1	—	1
Sleep	D012890	GO_0030431	—	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Postoperative pain	D010149	—	G89.18	—	—	2	—	—	2
Pain	D010146	EFO_0003843	R52	1	—	1	—	—	2
Metabolic syndrome	D024821	EFO_0000195	E88.810	—	—	1	—	—	1
Hypertriglyceridemia	D015228	EFO_0004211	—	—	—	1	—	—	1
Left ventricular dysfunction	D018487	—	—	—	—	1	—	—	1
Ventricular remodeling	D020257	—	—	—	—	1	—	—	1
Myocarditis	D009205	—	I51.4	—	—	1	—	—	1
Pericarditis	D010493	EFO_0007427	I30	—	—	1	—	—	1
Microvascular angina	D017566	—	—	—	—	1	—	—	1
Vascular remodeling	D066253	—	—	—	—	1	—	—	1

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Indications Phases 2

No data

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	1	—	—	—	—	1
Malnutrition	D044342	EFO_0008572	E40-E46	1	—	—	—	—	1
Therapeutic equivalency	D013810	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cough	D003371	—	R05	—	—	—	—	2	2
Essential hypertension	D000075222	—	I10	—	—	—	—	1	1
Atopic dermatitis	D003876	EFO_0000274	L20	—	—	—	—	1	1
Dermatitis	D003872	—	L30.9	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Diphenhydramine
INN	diphenhydramine
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 class	first-generation antihistamine (ethanolamine), anticholinergic, hallucinogen (deliriant)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CN(C)CCOC(c1ccccc1)c1ccccc1

Identifiers

PDB	—
CAS-ID	58-73-1
RxCUI	—
ChEMBL ID	CHEMBL657
ChEBI ID	4636
PubChem CID	3100
DrugBank	DB01075
UNII ID	8GTS82S83M (ChemIDplus, GSRS)

Target

Agency Approved

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

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Variants

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Financial

Revenue by drug

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Estimated US medical usage

Diphenhydramine

Acetaminophen

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Diphenhydramine

Acetaminophen

Phenylephrine

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Diphenhydramine

Phenylephrine

Brompheniramine

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Diphenhydramine

Pentoxyverine

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Diphenhydramine

Pentoxyverine

Phenylephrine

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Diphenhydramine

Phenylephrine

Codeine

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Diphenhydramine

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Diphenhydramine

Phenylephrine

Hydrocodone

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Diphenhydramine

Lidocaine

Nystatin

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Diphenhydramine

Phenylephrine

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Trends

PubMed Central

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Additional graphs summarizing 20,235 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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47,001 adverse events reported

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