FDA label 7de540a2-28f8-41fc-bf5e-289f520fec16

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: 8fa15a59-fb7b-4c88-a61d-0cf977a6e834
SPL ID: 7de540a2-28f8-41fc-bf5e-289f520fec16
Version: 1
Effective date: 2021-11-12
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:17:38

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		7de540a2-28f8-41fc-bf5e-289f520fec16	id
spl set id		8fa15a59-fb7b-4c88-a61d-0cf977a6e834	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 Ask a doctor before use if you have ear drainage, discharge, ear pain, irritation or rash in the ear, dizziness, had an injury or perforation of the ear drum. When using this product avoid contact with the eyes. Stop use and ask a doctor if you need to use for more than four days. Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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