PreviDent Fresh Mint

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)

Brand name: PreviDent Fresh Mint
Generic name: SODIUM FLUORIDE
Manufacturer: Colgate Oral Pharmaceuticals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 2ecc57ec-cd25-4911-9247-6375569b8abe
SPL ID: e16a75ef-1e92-474e-8134-f9f3416a07ef
Version: 8
Effective date: 2023-03-17
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:42:24

Harmonized routes table
Harmonized routes
DENTAL

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		PreviDent Fresh Mint	openfda.brand_name
brand name		PreviDent Very Berry	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Colgate Oral Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	0126-0288-02	openfda.package_ndc
ndc	package	0126-0088-02	openfda.package_ndc
ndc	product	0126-0088	openfda.product_ndc
ndc	product	0126-0288	openfda.product_ndc
ndc11	package	00126028802	derived:openfda.package_ndc
ndc11	package	00126008802	derived:openfda.package_ndc
rxcui		630194	openfda.rxcui
rxcui		392038	openfda.rxcui
spl id		e16a75ef-1e92-474e-8134-f9f3416a07ef	id
spl set id		2ecc57ec-cd25-4911-9247-6375569b8abe	set_id
unii		8ZYQ1474W7	openfda.unii

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.