DIPHENHYDRAMINE HYDROCHLORIDE 50mg

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Generic name
DIPHENHYDRAMINE HYDROCHLORIDE 50MG
Manufacturer
AMZ789 LLC
Product type
HUMAN OTC DRUG
SPL set ID
af0b1b08-e269-6399-e053-2a95a90ac12d
SPL ID
47d40d86-cbe8-fc70-e063-6394a90a2ff3
Version
5
Effective date
2026-01-07
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:45:31
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings for children under 12 years of age with any other products containing diphenhydramine, even one used on skin Ask a doctor or pharmacist before use if you have a breathing problem such as emphysema or chronic bronchitis, glaucoma, trouble urinating due to an enlarged prostate gland you are taking sedatives or tranquilizers When using this product avoid alcholic drinks Stop use and ask a doctor if sleeplessness presists continuously for more than 2 weeks. Insomnic may be a symptom of a series underlying medical illness If pregnant or breast-feeding ask a health professional before use In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.