FDA label 2916a784-a7a9-c4a6-e063-6394a90a3788

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)

SPL set ID
d4ec6dfd-61b0-7153-e053-2995a90ad88f
SPL ID
2916a784-a7a9-c4a6-e063-6394a90a3788
Version
2
Effective date
2024-12-12
Source export date
2026-11-06
Source partition
14
Source file
https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/2cac198adf50bf0f7077ca012f418bbee1fb171f907f83d6a83048d9770d345b/drug-label-0014-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:10:48

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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

Reported adverse events (FAERS/openFDA)#

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