FDA.reportPublic FDA data

meijer Sensitive EXTRA WHITENING

Manufacturer
Meijer, Inc.
Effective date
2025-10-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:41:31

Label at a glance#

Productmeijer Sensitive EXTRA WHITENING
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure10 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 age: C...

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• 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.

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-32, Sodium Lauryl Sulfate, Glycerin, Flavor, Cellulose Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, Benzyl Alcohol, Sodium Benzoate, Trisodium Phosphate, Sodium Saccharin, Sodium Hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

MAXIMUM STRENGTH WITH FLUORIDE

COMPARE TO SENSODYNE® EXTRA WHITENING ACTIVE INGREDIENTS*

FOR SENSITIVE TEETH AND CAVITY PROTECTION
RELIEVES PAINFUL SENSITIVITY

EXTRA WHITENING

TWIN PACK

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

C. No. DNH/COS/DNH/52 • 1223049071 • 1223180493

MADE IN INDIA

*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc. owner of the registered trademark Sensodyne®.

OUR QUALITY GUARANTEE
www.meijer.com/satisfaction

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

meijer Sensitive EXTRA WHITENINGmeijer Sensitive EXTRA WHITENING

meijer Sensitive EXTRA WHITENINGmeijer Sensitive EXTRA WHITENING

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN3
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD3
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0038-1meijer Sensitive EXTRA WHITENING1 in 1 BOXPASTE, DENTIFRICE13
79481-0038-1meijer Sensitive EXTRA WHITENING113 g in 1 TUBEPASTE, DENTIFRICE1133
79481-0038-2meijer Sensitive EXTRA WHITENING113 g in 1 TUBEPASTE, DENTIFRICE1133
79481-0038-2meijer Sensitive EXTRA WHITENING2 in 1 BOXPASTE, DENTIFRICE23

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79481-003879481-0038-1, 79481-0038-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-01-23full-release2026-06-01 00:53:58

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 Sensitive EXTRA WHITENINGPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.bbcffb88-0bd4-4883-bb83-0b7a1428ad122025-10-20WarningsExact identifier
ndc (package): 79481-0038-1
ndc (package): 79481-0038-2
ndc (product): 79481-0038
ndc11 (package): 79481003802
ndc11 (package): 79481003801
spl id: 73a33d8d-3ebb-401b-a246-ce8e3a5006a4
spl set id: bbcffb88-0bd4-4883-bb83-0b7a1428ad12

Reported adverse events (FAERS/openFDA)#

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