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
CVS Pharmacy, Inc
Product type
HUMAN OTC DRUG
SPL set ID
f4468840-e17c-6888-e053-2995a90a04a0
SPL ID
28513391-e715-29a1-e063-6394a90a0340
Version
2
Effective date
2024-12-02
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:15:45
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Do not use  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 (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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