FDA.reportPublic FDA data

FDA label e957ff8c-d988-4bf0-a7ba-7f7d308cede4

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
8ae3620c-0b7d-432a-aa00-5b9934ff8e76
SPL ID
e957ff8c-d988-4bf0-a7ba-7f7d308cede4
Version
1
Effective date
2012-11-01
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:36

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. 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 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.