FDA label 8be9cee5-e5b3-41b1-8d64-62733b2583f6

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: a85fc72b-304c-42a7-a4d8-b511e561f78f
SPL ID: 8be9cee5-e5b3-41b1-8d64-62733b2583f6
Version: 12
Effective date: 2018-12-22
Source export date: 2026-08-17
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-08-17/02a497ed455224db2b03c6e57c80c30915819e1b465153908a5d9e68e3a47b21/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run: 20260818T065550Z
Imported at: 2026-08-18 08:07:21

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		8be9cee5-e5b3-41b1-8d64-62733b2583f6	id
spl set id		a85fc72b-304c-42a7-a4d8-b511e561f78f	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

Warning: Keep out of reach of children. Do not swallow. If swallowed during treatment, administer milk, limewater, or antacid. If larger dose is ingested (more than 1/4 ounce), contact poison control and immediately seek medical help. Do not use on patients with an allergy to fluoride.

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: Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. Individuals hypersensitive to fluoride may have an adverse reaction.