Diphenhydramine HCl

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 HCl
Generic name
DIPHENHYDRAMINE HCL
Manufacturer
Preferred Pharmaceuticals Inc.
Product type
HUMAN OTC DRUG
SPL set ID
d3f769d7-3cbb-4469-bff8-2015619ee115
SPL ID
32532b11-59a5-4d31-8206-5a9fc2b76f45
Version
5
Effective date
2026-04-06
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/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:25:52
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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 • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • excitability may occur, especially in children • marked drowsiness may occur • use caution when driving a motor vehicle or operating machinery 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.

Reported adverse events (FAERS/openFDA)#

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