Rexall Restore and Defend Sensitive Whitening

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: Rexall Restore and Defend Sensitive Whitening
Generic name: STANNOUS FLUORIDE
Manufacturer: Old East Main CO.
Product type: HUMAN OTC DRUG
SPL set ID: 691c9638-75d2-4e53-bec4-2eafacd7216c
SPL ID: 513e53d3-ae6a-4030-8052-e7b7b6ba32b3
Version: 2
Effective date: 2024-10-14
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:36:18

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M021	openfda.application_number
brand name		Rexall Restore and Defend Sensitive Whitening	openfda.brand_name
generic name		STANNOUS FLUORIDE	openfda.generic_name
manufacturer name		Old East Main CO.	openfda.manufacturer_name
ndc	package	55910-820-01	openfda.package_ndc
ndc	product	55910-820	openfda.product_ndc
ndc11	package	55910082001	derived:openfda.package_ndc
rxcui		416784	openfda.rxcui
spl id		513e53d3-ae6a-4030-8052-e7b7b6ba32b3	id
spl set id		691c9638-75d2-4e53-bec4-2eafacd7216c	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 Stop use and ask a dentist if • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use • Keep out of reach of children under 12 years of age. If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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