DIPHEN

Post-LOE

diphenhydramine hydrochloride

Gland Pharma

ANDAORALELIXIR

Approved

Feb 1979

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

DIPHEN (diphenhydramine hydrochloride) by Gland Pharma is clinical pharmacology diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Approved for common cold symptoms: cough due to minor throat & bronchial irritation helps loosen phlegm (mucus), thin bronchial secretions to: drain bronchial tubes make coughs more productive. First approved in 1979.

Drug data last refreshed 18h ago

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 (2)

common cold symptoms: cough due to minor throat & bronchial irritation helps loosen phlegm (mucus)

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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.

Clinical Trials (19)

NCT05036174N/AUnknown

Diphenhydramine Ointment for Knee Osteoarthritis

Started Sep 2021

30 enrolled

Osteoarthritis

NCT04189588Phase 2Completed

Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine

Started Mar 2020

34 enrolled

Oncology Patients Receiving Chemotherapy

NCT04175834Phase 3Completed

Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab

Started Feb 2020

19 enrolled

Multiple SclerosisInfusion Reaction

NCT03424135Phase 1Completed

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

NCT03396250Phase 1Completed

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