FDA label 805c7ea8-7448-43ff-9feb-1ce985d469dc

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: a3dde703-c8c8-42fe-ab51-e9bcf4bce1a4
SPL ID: 805c7ea8-7448-43ff-9feb-1ce985d469dc
Version: 3
Effective date: 2010-08-25
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 05:13:13

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		805c7ea8-7448-43ff-9feb-1ce985d469dc	id
spl set id		a3dde703-c8c8-42fe-ab51-e9bcf4bce1a4	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 - A physician should be consulted about earache in children. - Initial exacerbation of symptoms may occur. - Keep this and all medicines out of the reach of children. - If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children Keep this and all medicines out of the reach of children.

Reported adverse events (FAERS/openFDA)#

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