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
PD-Rx Pharmaceuticals, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
879a7804-f3d4-4a3d-bc92-b473499d6c95
SPL ID
56d551ca-b3ee-5d72-e063-6294a90af6c8
Version
7
Effective date
2026-07-17
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 06:18:19
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.