FDA.reportPublic FDA data

Sensitive Whitening Tooth-paste

Manufacturer
Meijer, Inc.
Effective date
2025-12-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:28:34

Label at a glance#

ProductSensitive Whitening Tooth-paste
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

•  Adults and children 12 years & 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) 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 ...

Storage and handling

Store at room temperature 68-77°F (20-25°C)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate (5%)

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Antihypersensitivity

Anticavity

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS 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 

• Keep out of reach children under 12 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years & 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) 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.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, hydrated silica, treated water, PEG-1500, sodium lauryl sulfate, flavor, glycerin, cellulose gum, tetrasodium pyrophosphate, titanium dioxide, sodium benzoate, trisodium phosphate, sodium saccharin, sodium hydroxide, methylparaben, propylparaben

SPL UNCLASSIFIED SECTION

Compare to Sensodyne®

Extra Whitening active ingredients*

Maximum Strength with Fluoride

For Sensitive Teeth and Cavity Protection  | Relieves Painful Sensitivity

Brushing twice a day helps build a protective coating against painful sensitivity.

• Reduces painful sensitivity

• cavity protection formula

• Freshens breath

• Helps remove stains for a whiter smile

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com • 909-434-0911

OUR QUALITY GUARANTEE

WWW.MEIJER.COM/SATISFACTION

MADE IN INDIA

PAPER BOX

PLASTIC TUBE

how2recycle.info

*This product is not manufactured or distributed by Block Drug Company, Inc. owner of the registered trademark Sensodyne®.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) ToothpastePSN4
1038800potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG ToothpasteSCD4
1038800K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY4
1038800Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY4
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79481-0008-12025-12-24C16284748780-12cef2736-ab49-d83d-e063-dadaa90ab31fmeijer ​® sensitive toothpaste EXTRA WHITENING
79481-0008-12025-01-30C16284748780-12cef2736-ab49-d83d-e063-dadaa90ab31fmeijer ​® sensitive toothpaste EXTRA WHITENING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0008-1Sensitive Whitening Tooth-paste113 g in 1 TUBEPASTE, DENTIFRICE1134
79481-0008-1Sensitive Whitening Tooth-paste1 in 1 BOXPASTE, DENTIFRICE14

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79481-000879481-0008-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML

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
Sensitive Whitening Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.c25b6a95-e604-48e3-bc55-595969d1ce9b2025-12-23WarningsExact identifier
ndc (package): 79481-0008-1
ndc (product): 79481-0008
ndc11 (package): 79481000801
spl id: e9579105-80a5-440e-8da2-b31b65542f32
spl set id: c25b6a95-e604-48e3-bc55-595969d1ce9b

Reported adverse events (FAERS/openFDA)#

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