Application Nr Approved Date Route Status External Links
ANDA087513 1982-02-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage: Diphenhydramine Hydrochloride In The Oral Form Is Effective For The Following Indications: Antihistaminic: For Allergic Conjunctivitis Due To Foods; Mild, Uncomplicated Allergic Skin Manifestations Of Urticaria And Angioedema; Amelioration Of Allergic Reactions To Blood Or Plasma; Dermatographism; As Therapy For Anaphylactic Reactions Adjunctive To Epinephrine And Other Standard Measures After The Acute Manifestations Have Been Controlled. Motion Sickness: For Active And Prophylactic Treatment Of Motion Sickness. Antiparkinsonism: For Parkinsonism (including Drug-Induced) In The Elderly Unable To Tolerate More Potent Agents; Mild Cases Of Parkinsonism (including Drug-Induced) In Other Age Groups; In Other Cases Of Parkinsonism (including Drug-Induced) In Combination With Centrally Acting Anticholinergic Agents. Nighttime Sleep-Aid.

All Formulated Excipients (1 Total)

Name Structure Kind Function Status
1. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE ZINC20244