FDA label da544f85-8214-a467-e053-2995a90a1dff

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
98b35828-912c-4d08-b5b2-4829aee85742
SPL ID
da544f85-8214-a467-e053-2995a90a1dff
Version
5
Effective date
2024-09-16
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:15

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

For external use only Do not use • on large areas of the body • on broken, blistered or oozing skin • on poison ivy or sunburn • more often than directed • wtth any other product containing diphenhydramlne, even one taken by mouth • on chicken pox or measles When using this product avoid contact with the eyes Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days • condition clears up and occurs again within few days 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.