FDA.reportPublic FDA data

FDA label d5e3e7bd-6a94-4796-8ad0-1b3f0e464dd7

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
5cb4c9b2-a01d-474b-aa70-cf8dd8c81cd9
SPL ID
d5e3e7bd-6a94-4796-8ad0-1b3f0e464dd7
Version
2
Effective date
2018-12-13
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 03:01:46

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

Warning: This Packet contains sodium fluoride powder, contents poisonous if swallowed. keep away from children. Store in a dry place at controlled room temperature. For professional use only. DO NOT SWALLOW MISSUSE If child swallows dispensed amount of mouth rinse in a cup: 1. Do not panic -this amount should not hurt the child 2. In rare cases the child may feel slightly nauseous. The child may have a serving of milk or ice cream to relieve the nausea. EMERGENCY TREATMENT If a child swallows more than one dispensed amount in a cup or powder contents of the fluoride mouth rinse packet call the Poison Control Center at 800-222-1222

Reported adverse events (FAERS/openFDA)#

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