Diphenhydramine HYDROCHLORIDE

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
Generic name
DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Product type
HUMAN OTC DRUG
SPL set ID
25034563-6422-daf6-e063-6394a90af980
SPL ID
25034563-6423-daf6-e063-6394a90af980
Version
1
Effective date
2024-10-21
Source export date
2026-11-06
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/90742968499056f8845d54427ea2950526b02c3f289aedd40679ed8e120a0e89/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run
20261106T075659Z
Imported at
2026-11-06 08:41:16
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

 to make a child sleepy  with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have  a breathing problem such as emphysema or chronic bronchitis  glaucoma  trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product  marked drowsiness may occur  avoid alcoholic drinks  alcohol, sedatives and tranquilizers may increase drowsiness  be careful when driving a motor vehicle or operating machinery  excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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.