FDA label 097478f1-9b48-b749-e063-6394a90a9977

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: 097478f1-9b47-b749-e063-6394a90a9977
SPL ID: 097478f1-9b48-b749-e063-6394a90a9977
Version: 1
Effective date: 2023-11-05
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 02:25:57

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		097478f1-9b48-b749-e063-6394a90a9977	id
spl set id		097478f1-9b47-b749-e063-6394a90a9977	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 1. Not intended for children under 16. 2. Do not swallow strip. 3. Avoid contact of strips with eyes or skin. 4. If the strip comes into contact with skin, it may cause temporary skin irritation. 5. If there is any discomfort, please stop using and consult a dentist immediately 6. Not suitable for people who have ulcers, exposed gums or after oral surgery.

Reported adverse events (FAERS/openFDA)#

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