FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

openFDA label record#

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Brand name
Diphenhydramine Hydrochloride
Generic name
DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
Medical Purchasing Solutions, LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
51bb483f-3fe6-8a94-e063-6394a90acf7d
SPL ID
51bb1ca2-32ef-4840-e063-6394a90a6faa
Version
1
Effective date
2026-05-13
Source export date
2026-08-01
Applications, Product NDCs, Package NDCs table
ApplicationsProduct NDCsPackage NDCsRxCUIsUNIIsRoutes
ANDA20533671872-737371872-7373-11723740TC2D6JAD40INTRAMUSCULAR, INTRAVENOUS

Warnings cross-check#

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warnings

WARNINGS Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy or bladder-neck obstruction. Local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous diphenhydramine. Use in Pediatric Patients In pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions or death. As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young pediatric patient, particularly, they may produce excitation. Use in the Elderly (approximately 60 years or older) Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS The most frequent adverse reactions are italicized. General Urticaria; drug rash; anaphylactic shock; photosensitivity; excessive perspiration; chills; dryness of mouth, nose and throat. Cardiovascular System Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic System Hemolytic anemia, thrombocytopenia, agranulocytosis. Nervous System Sedation , sleepiness , dizziness , disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions. Gastrointestinal System Epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation. Genitourinary System Urinary frequency, difficult urination, urinary retention, early menses. Respiratory System Thickening of bronchial secretions , tightness of chest and wheezing, nasal stuffiness.