Sensodyne Pronamel

Manufacturer
Haleon US Holdings LLC
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:39:00

Label at a glance#

ProductSensodyne Pronamel Clinical Enamel Strength Whitening Action
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 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...

Storage and handling

do not store above 25°C (77°F)

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

STORAGE AND HANDLING SECTION

  • do not store above 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, xanthan gum, silica, titanium dioxide, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

ALWAYS FOLLOW THE LABEL

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW HALEON

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNEPRONAMEL

CLINICAL ENAMEL STRENGTH

3X STRONGER ENAMEL PROTECTION*

# 1 DENTIST RECOMMENDED BRAND FOR ENAMEL EROSION

WHITENING ACTION

NET WT 2.3 OZ (65.2 g)

62000000211437 – Front Carton

Sensodyne Pronamel Clin 2.3 oz (65.2 g).jpg
Sensodyne Pronamel Clin 2.3 oz (65.2 g).jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN2
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD2
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY2
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0811-02Sensodyne PronamelClinical Enamel Strength Whitening Action96.4 g in 1 TUBEPASTE96.42
0135-0811-02Sensodyne PronamelClinical Enamel Strength Whitening Action1 in 1 CARTONPASTE12
0135-0811-03Sensodyne PronamelClinical Enamel Strength Whitening Action1 in 1 CARTONPASTE12
0135-0811-03Sensodyne PronamelClinical Enamel Strength Whitening Action65.2 g in 1 TUBEPASTE65.22
0135-0811-23Sensodyne PronamelClinical Enamel Strength Whitening Action96.4 g in 1 TUBEPASTE96.42
0135-0811-23Sensodyne PronamelClinical Enamel Strength Whitening Action2 in 1 CARTONPASTE22

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-08110135-0811-03, 0135-0811-02, 0135-0811-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-09-11full-release2026-06-01 00:50:50

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 Clinical Enamel Strength Whitening ActionPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCe8a62f24-1db6-45fb-b6e1-5e57103f82bc2025-10-14WarningsExact identifier
ndc (package): 0135-0811-02
ndc (package): 0135-0811-23
ndc (package): 0135-0811-03
ndc (product): 0135-0811
ndc11 (package): 00135081123
ndc11 (package): 00135081103
ndc11 (package): 00135081102
spl id: 4124888c-4bab-f7b5-e063-6394a90a7532
spl set id: e8a62f24-1db6-45fb-b6e1-5e57103f82bc

Reported adverse events (FAERS/openFDA)#

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