NDAORALCAPSULE
Approved
Mar 1946
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
BENADRYL (diphenhydramine hydrochloride) by Johnson & Johnson is clinical pharmacology diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Approved for nasal congestion. First approved in 1946.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Benadryl (diphenhydramine hydrochloride) is a first-generation antihistamine used primarily for nasal congestion and allergy relief. The drug works by competing with histamine for cell receptor sites while producing anticholinergic (drying) and sedative side effects. Diphenhydramine is widely distributed throughout the body including the CNS, with partial hepatic metabolism and urinary excretion.
LOE Approaching
Legacy OTC product nearing end-of-life with limited patent protection; commercial teams likely focused on cost management and legacy brand maintenance rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. Diphenhydramine hydrochloride in the injectable form has a rapid onset of…
Indications (1)
Clinical Trials (4)
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions
Started Mar 2018
60 enrolled
Clinical Pharmacology
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects
Started Feb 2018
36 enrolled
Pain
Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination
Started Jan 2012
32 enrolled
Therapeutic Equivalence
Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride
Started Oct 2006
36 enrolled
Nasal Congestion
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.