FDA.reportPublic FDA data

Meijer

Manufacturer
Meijer Distribution Inc | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
monthly-update
Hydrated at
2026-06-03 17:52:09

Label at a glance#

ProductMeijer Restore and Defend Sensitive
Active ingredientSTANNOUS FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Stannous Fluoride 0.454% (w/v 0.15% fluoride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity/Antihypersensitivity

INDICATIONS & USAGE SECTION

Uses

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for brushing is accidentally swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.

  • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • Minimize swallowing
  • Spit out after brushing
  • Children under 12 years of age: consult a dentist or doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

SPL UNCLASSIFIED SECTION

DIST. BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

MADE IN USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

meijer™

WHITENING

Restore & Defend Toothpaste

For sensitive teeth and cavity protection

Builds protective coating on sensitive areas of teeth

NET WT 3.4 OZ (96.4 g)

MeijerRestoreWhiten2821277R1MeijerRestoreWhiten2821277R1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN9
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD9
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY9
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY9
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-530-19MeijerRestore and Defend Sensitive1 in 1 CARTONPASTE, DENTIFRICE19
41250-530-19MeijerRestore and Defend Sensitive96.4 g in 1 TUBEPASTE, DENTIFRICE96.49

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-53041250-530-19

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
HYDRATED SILICAY6O7T4G8P9IACT
STANNOUS FLUORIDE3FTR44B32QACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-08-08full-release2026-06-01 01:09:57

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Restore and Defend SensitiveSTANNOUS FLUORIDEMeijer Distribution Inc82bdfdb5-39f2-8c09-e053-2991aa0a096c2026-01-08WarningsExact identifier
ndc (package): 41250-530-19
ndc (product): 41250-530
ndc11 (package): 41250053019
spl id: 47e54fbe-10ba-d5b4-e063-6294a90a1ce3
spl set id: 82bdfdb5-39f2-8c09-e053-2991aa0a096c

Reported adverse events (FAERS/openFDA)#

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