TruGuard 5000

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: TruGuard 5000
Generic name: SODIUM FLUORIDE TOOTHPASTE
Manufacturer: The Atlanta Dental Supply Company DBA Advanced Dental Products
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 3b8efdcf-5beb-46c2-b118-64940a7fc74b
SPL ID: 6da572ed-8186-43c4-af53-cdc66568552c
Version: 4
Effective date: 2024-12-28
Source export date: 2026-10-12
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:28:13

Harmonized routes table
Harmonized routes
ORAL

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		TruGuard 5000	openfda.brand_name
generic name		SODIUM FLUORIDE TOOTHPASTE	openfda.generic_name
manufacturer name		The Atlanta Dental Supply Company DBA Advanced Dental Products	openfda.manufacturer_name
ndc	package	71347-500-04	openfda.package_ndc
ndc	product	71347-500	openfda.product_ndc
ndc11	package	71347050004	derived:openfda.package_ndc
spl id		6da572ed-8186-43c4-af53-cdc66568552c	id
spl set id		3b8efdcf-5beb-46c2-b118-64940a7fc74b	set_id
unii		8ZYQ1474W7	openfda.unii
unii		RU45X2JN0Z	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 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of the cream which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS: Allergic reaction and other idiosyncrasies have been rarely reported.

Reported adverse events (FAERS/openFDA)#

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