FDA label 28de35d0-7e3d-dfb1-e063-6294a90a1e56

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
18df23eb-1f3d-4936-b9bd-e5d71d100bcb
SPL ID
28de35d0-7e3d-dfb1-e063-6294a90a1e56
Version
4
Effective date
2024-12-09
Source export date
2026-10-30
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/2026-10-30/0b630a6825fc0c8abba22d7c8fd4d069bde78bef928766047ddbb369119f337f/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run
20261102T182004Z
Imported at
2026-11-02 18:58:55

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.