FDA label 087a1d09-38e2-d509-e063-6394a90ab8df

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: 1cf1d27a-5fd0-4304-9748-ef36f75099e5
SPL ID: 087a1d09-38e2-d509-e063-6394a90ab8df
Version: 6
Effective date: 2023-10-24
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 06:02:54

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		087a1d09-38e2-d509-e063-6394a90ab8df	id
spl set id		1cf1d27a-5fd0-4304-9748-ef36f75099e5	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 Keep away from eyes. Do not take by mouth. Earache drops are only to be used in ears. As with any drug, ask a doctor before use ii pregnant or breast-reeding. Do not use if you have ear tubes, damaged ear drums or after ear surgery. Consult a physician if: ■ symptoms persist for more than 48 hours or wcraen. ■ discharge from ear is present. ■ symptoms are accompanied by a fever (over 101'F).

Reported adverse events (FAERS/openFDA)#

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