FDA label 2b216c1b-324b-6135-e063-6394a90ae881

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
610179fe-3775-4026-a870-4a0c579a9eee
SPL ID
2b216c1b-324b-6135-e063-6394a90ae881
Version
9
Effective date
2025-01-07
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:58:29

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 For external use only. Flammable: Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F ​Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth ​Stop use and ask doctor if conditions worsens symptoms last more than 7 days or clear up and occur again within a few days When using this product avoid contact with eyes use only as directed ​Keep out of reach of children. If swallowed, 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.