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
Belleview Biosciences
Product type
HUMAN OTC DRUG
SPL set ID
1db57d86-39f0-f8ca-e063-6394a90a6397
SPL ID
3765beab-e853-b34f-e063-6394a90ac9d5
Version
2
Effective date
2025-06-12
Source export date
2026-10-27
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/2026-10-27/b7a5e61d87a3b8f87f4c3ff7b526bfbf6baf84c840f565574c7d83d4083e2b38/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 20:48:12
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: ■ with any other product containing diphenhydramine, even one used on skin ■ to make a child sleepy Ask a doctor before use if you have: ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ trouble urinating due to the enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product: ■ excitability might occur, especially in children ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness effect ■ be careful 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 (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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