FDA label 398e485a-64c5-4d1e-81f0-9d50a17421d6

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: f1e5f1e0-ad3f-4bc6-a2ca-5ec71f081815
SPL ID: 398e485a-64c5-4d1e-81f0-9d50a17421d6
Version: 1
Effective date: 2024-12-18
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:11:13

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		398e485a-64c5-4d1e-81f0-9d50a17421d6	id
spl set id		f1e5f1e0-ad3f-4bc6-a2ca-5ec71f081815	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 use this product for more than 7 days unless directed by a dentist or healthcare provider When using this product do not swallow do not exceed recommended dosage Stop use and see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days Keep out of reach of children. If more than used for rinsing is accidentally 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.