FDA label 88353f85-2581-4372-a83a-efb73c4d07cf

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: 788ccc23-2abf-48ce-9d97-9283980b18ec
SPL ID: 88353f85-2581-4372-a83a-efb73c4d07cf
Version: 3
Effective date: 2023-03-07
Source export date: 2026-10-12
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/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:24:14

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		88353f85-2581-4372-a83a-efb73c4d07cf	id
spl set id		788ccc23-2abf-48ce-9d97-9283980b18ec	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 Do not take by mouth. Ear drops are only to be used in the ears. Do not use with ear tubes. Stop use and ask a doctor if symptoms persist for more than 48 hours there is discharge from the ear there is a fever of 102°F or greater If pregnant or breast-feeding ask a doctor before use. Keep out of reach of children. In case of accidental ingestion, 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.