Data completeness
2/8 — Basic
BENYLIN (diphenhydramine hydrochloride) by Pfizer is clinical pharmacology diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects.
Drug data last refreshed 14h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BENYLIN is an oral syrup formulation of diphenhydramine hydrochloride, a first-generation antihistamine with anticholinergic and sedative properties. It works by competing with histamine for cell receptor sites on effector cells to relieve allergy and cold symptoms. The drug is widely distributed throughout the body including the CNS, with hepatic metabolism and urinary excretion.
Pre-Launch
Pre-launch stage indicates early-stage commercial planning with limited team infrastructure; significant growth potential pending market entry.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.