FDA label 4ce135fa-5afd-4639-bb93-90b7e58859fe

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: 04b9fe63-81c8-43ac-ad2d-95574df5c51c
SPL ID: 4ce135fa-5afd-4639-bb93-90b7e58859fe
Version: 1
Effective date: 2012-04-27
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:58:42

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		4ce135fa-5afd-4639-bb93-90b7e58859fe	id
spl set id		04b9fe63-81c8-43ac-ad2d-95574df5c51c	set_id

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 use - with any other product containing diphenhydramine, even one taken by mouth. - On large areas of the body Ask a doctor before use - on chicken pox - on measles When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days. - 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.

Reported adverse events (FAERS/openFDA)#

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