Pro-Den Rx

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-Den Rx
Generic name: STANNOUS FLUORIDE
Manufacturer: Den-mat Holdings, Llc
Product type: HUMAN OTC DRUG
SPL set ID: 9036aa8a-59b1-41b0-b3cb-529d3303a1c0
SPL ID: 0a95fcbe-e811-031d-e063-6294a90aec1b
Version: 6
Effective date: 2023-11-20
Source export date: 2026-10-27
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:12:09

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
application number		M021	openfda.application_number
brand name		Pro-Den Rx	openfda.brand_name
generic name		STANNOUS FLUORIDE	openfda.generic_name
manufacturer name		Den-mat Holdings, Llc	openfda.manufacturer_name
ndc	package	59883-720-08	openfda.package_ndc
ndc	product	59883-720	openfda.product_ndc
ndc11	package	59883072008	derived:openfda.package_ndc
spl id		0a95fcbe-e811-031d-e063-6294a90aec1b	id
spl set id		9036aa8a-59b1-41b0-b3cb-529d3303a1c0	set_id
unii		3FTR44B32Q	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 When using this product it may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. Keep out of reach of children. If more than used for rinsing s accidentally swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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