Sensodyne Pronamel

Manufacturer
Haleon US Holdings LLC
Effective date
2024-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:50:50

Label at a glance#

ProductSensodyne Pronamel Clinical Enamel Strength Deep Clean
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, xanthan gum, cocamidopropyl betaine, sodium methyl cocoyl taurate, 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

SENSODYNE

PRONAMEL CLINICAL ENAMEL STRENGTH

3X STRONGER ENAMEL PROTECTION*

# 1 DENTIST RECOMMENDED BRAND FOR ENAMEL EROSION

DEEP CLEAN

NET WT 2.3 OZ (65.2 g)

62000000212484 – Front Carton

Sensodyne Pronamel Deep Clean 2.3 oz (65.2 g).jpg
Sensodyne Pronamel Deep Clean 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 % ToothpastePSN1
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD1
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY1
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY1

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
0135-0810-01Sensodyne PronamelClinical Enamel Strength Deep Clean23 g in 1 TUBEPASTE231
0135-0810-02Sensodyne PronamelClinical Enamel Strength Deep Clean1 in 1 CARTONPASTE11
0135-0810-02Sensodyne PronamelClinical Enamel Strength Deep Clean96.4 g in 1 TUBEPASTE96.41
0135-0810-03Sensodyne PronamelClinical Enamel Strength Deep Clean1 in 1 CARTONPASTE11
0135-0810-03Sensodyne PronamelClinical Enamel Strength Deep Clean65.2 g in 1 TUBEPASTE65.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0810SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH DEEP CLEAN (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]1Current NDC, 5 package rows20250107_cfda7efa-86fa-470d-a79f-81907e31778a.zip

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
0135-08100135-0810-03, 0135-0810-02, 0135-0810-01

Ingredients#

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

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

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 Clinical Enamel Strength Deep CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcfda7efa-86fa-470d-a79f-81907e31778a2024-08-14WarningsExact identifier
ndc (package): 0135-0810-01
ndc (package): 0135-0810-03
ndc (package): 0135-0810-02
ndc (product): 0135-0810
ndc11 (package): 00135081001
ndc11 (package): 00135081003
ndc11 (package): 00135081002
spl id: 1fab5aa6-1081-c4f5-e063-6294a90a5d1c
spl set id: cfda7efa-86fa-470d-a79f-81907e31778a

Reported adverse events (FAERS/openFDA)#

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