FDA label 47436dfc-2331-fde3-e063-6294a90a0afb

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
3cd1933c-6341-50d6-e063-6294a90aca32
SPL ID
47436dfc-2331-fde3-e063-6294a90a0afb
Version
2
Effective date
2025-12-31
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:27:35

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For external use only. Flammable: Keep away from fire or flame. ​Do not use on large areas of the body on chicken pox, poison ivy, or sunburn on broken, blistered, or oozing skin more often than directed with any other product containing diphenhydramine, even one taken by mouth ​When using this product avoid contact with the eyes ​Stop use and ask doctor if conditions worsens symptoms persist for more than 7 days or clear up and occur again within a few days ​Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings

Flammable: Keep away from fire or flame.

Reported adverse events (FAERS/openFDA)#

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