FDA.reportPublic FDA data

Sensodyne Pronamel

Manufacturer
Haleon US Holdings LLC
Effective date
2024-09-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:18:56

Label at a glance#

ProductSensodyne Pronamel Gentle Whitening Advanced
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 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 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. • children under 12 years of age:...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purposes

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

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. 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

OTHER SAFETY INFORMATION

  • do not store above 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Generic Section

SPL UNCLASSIFIED SECTION

SENSODYNE PRONAMEL

Healthy white teeth start with strong enamel.

Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

ACID ATTACKS ENAMEL

WEAKENING THE ENAMEL STRUCTURE

PRONAMEL REBUUILDS & RESTORES ENAMEL

FOR STRONG HEALTHY TEETH

Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

* removes stains

ALWAYS FOLLOW THE LABEL

CARTON RECYCLE

TUBE RECYCLE

CAP† CHECK LOCALLY

† Recycling facilities for the cap may not exist in your area

Save Water

Turn off tap while brushing

Recyclable Packaging

Recyclable Carton

Recyclable Tube & Cap†

SPECIALIST ENAMEL PROTECTION

The acids in your diet can damage tooth enamel, leading to dull, yellow teeth.

Wine Acids

Fruit Acids

Soda Acids

Pronamel strengthens acid weakened enamel and protects teeth from these acids, keeping teeth strong, healthy and white.

SENSODYNE PRONAMEL

POWERFUL WHITENING*

GENTLE ON ENAMEL

#1 DENTIST RECOMMENDED ENAMEL BRAND

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 PACK

SENSODYNE PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

Alpine Breeze

GENTLE WHITENING

ADVANCED

POWERFUL WHITENING*,

GENTLE ON ENAMEL

4 TUBES OF 6.5 OZ (184 g) EACH – TOTAL NET WT 26 OZ (736 g)

Sensodyne Pronamel GW Adv 4 pk
Sensodyne Pronamel GW Adv 4 pk

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN5
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD5
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY5
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0580-01Sensodyne PronamelGentle Whitening Advanced184 g in 1 TUBEPASTE1845
0135-0580-01Sensodyne PronamelGentle Whitening Advanced1 in 1 CARTONPASTE15
0135-0580-02Sensodyne PronamelGentle Whitening Advanced4 in 1 CARTONPASTE45
0135-0580-02Sensodyne PronamelGentle Whitening Advanced184 g in 1 TUBEPASTE1845

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0580SENSODYNE PRONAMEL GENTLE WHITENING ADVANCED (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 4 package rows20240906_94e07979-943b-45bb-8e2b-90d686f3692e.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-05800135-0580-01, 0135-0580-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
Sensodyne Pronamel Gentle Whitening AdvancedPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC94e07979-943b-45bb-8e2b-90d686f3692e2024-09-04WarningsExact identifier
ndc (package): 0135-0580-01
ndc (package): 0135-0580-02
ndc (product): 0135-0580
ndc11 (package): 00135058002
ndc11 (package): 00135058001
spl id: ae922167-f3d1-461d-9233-114b01b349c1
spl set id: 94e07979-943b-45bb-8e2b-90d686f3692e

Reported adverse events (FAERS/openFDA)#

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