PRO Gel 5000 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: PRO Gel 5000 Mint
Generic name: SODIUM FLUORIDE
Manufacturer: DENTAL ALLIANCE HOLDINGS LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: f127e236-5207-948b-e053-2a95a90ab740
SPL ID: 424ae751-1f8e-4e67-ba2e-b368d447053e
Version: 3
Effective date: 2025-12-29
Source export date: 2026-10-27
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/55ffdfed5c29f1b4aed512886bd3fb7831e157cc4948137779971a558752ed2b/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:08:26

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		PRO Gel 5000 Citrus	openfda.brand_name
brand name		PRO Gel 5000 Mint	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		DENTAL ALLIANCE HOLDINGS LLC	openfda.manufacturer_name
ndc	package	61578-216-01	openfda.package_ndc
ndc	package	61578-215-01	openfda.package_ndc
ndc	product	61578-216	openfda.product_ndc
ndc	product	61578-215	openfda.product_ndc
ndc11	package	61578021601	derived:openfda.package_ndc
ndc11	package	61578021501	derived:openfda.package_ndc
rxcui		392038	openfda.rxcui
spl id		424ae751-1f8e-4e67-ba2e-b368d447053e	id
spl set id		f127e236-5207-948b-e053-2a95a90ab740	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 if water fluoridation exceeds 0.6 ppm. 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.