FDA label 62d78f74-8a9e-47b8-8d3c-2ce09d26ed43

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: 540306ab-083a-4129-9c66-7ff5e425d9dc
SPL ID: 62d78f74-8a9e-47b8-8d3c-2ce09d26ed43
Version: 2
Effective date: 2019-09-10
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:34:18

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		62d78f74-8a9e-47b8-8d3c-2ce09d26ed43	id
spl set id		540306ab-083a-4129-9c66-7ff5e425d9dc	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 Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in the areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel. Use cautiously in patients with porcelain or ceramic restorations as per PRECAUTIONS below. Read directions carefully before using. Keep out of reach of infants and children.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Contact with abraded or sensitive gingival tissue may produce discomfort. Allergic reactions and other idiosyncrasies have been rarely reported.

Reported adverse events (FAERS/openFDA)#

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