Application Nr Approved Date Route Status External Links
ANDA087513 None Oral None 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 (0 Total)

None

Active Ingredients ( 1 Total)

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

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