FDA label 9db79bec-3ba5-47dd-a001-ce7a4a7aec1a

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: dccdb4ef-203f-4c9b-85b4-a8a061c5656d
SPL ID: 9db79bec-3ba5-47dd-a001-ce7a4a7aec1a
Version: 6
Effective date: 2025-11-19
Source export date: 2026-10-30
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/a900515c00f4d0d29f88cc94ee68daf127f036296f87a6b4a8a3f964cd0433c0/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:49:49

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		9db79bec-3ba5-47dd-a001-ce7a4a7aec1a	id
spl set id		dccdb4ef-203f-4c9b-85b4-a8a061c5656d	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 Stop use and ask a dentist or doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness worsens swelling, rash or fever develops If pregnant or breast-feedin g or taking prescription drugs, ask a health care professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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