FDA.reportPublic FDA data

Sensodyne Pronamel

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:09:34

Label at a glance#

ProductSensodyne Pronamel Strong and Bright Enamel Mint
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 Consult a denti...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%

Sodium fluoride 0.25% (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

When using this product,

OTC - WHEN USING SECTION

if irritation occurs discontinue use.

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

Consult a dentist or doctor.

Other information

SPL UNCLASSIFIED SECTION

store below 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-866-844-2797

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0602-01

SENSODYNE

PRONAMEL

STRONG & Bright

ENAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

STRONGENAMEL

WHITERTEETH*

MINT

No. 1 DENTIST RECOMMENDED BRAND

FOR STRENGTHENING AND PROTECTING ENAMEL

*vs. ProNamel Daily Protection

NET WT 3.0 OZ (85 g)

Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

Sensodyne ProNamel STRONG & BrightENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

*vs. ProNamel Daily Protection

With twice daily brushing, the dual action formulation:

  • Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
  • Polishes away stains for WHITER BRIGHTER TEETH.

FRESHENSbreath and fights CAVITIES

GSKConsumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2017 GSK group of companies or its licensor

ALWAYS FOLLOW THE LABEL

105491XC 105491XC_ProNamel Strong & Bright_3.0 oz.JPG105491XC_ProNamel Strong & Bright_3.0 oz.JPG

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0603-01

SENSODYNE

PRONAMEL

STRONG & Bright

ENAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

STRONGENAMEL

WHITERTEETH*

EXTRA FRESH

No. 1 DENTIST RECOMMENDED BRAND

FOR STRENGTHENING AND PROTECTING ENAMEL

*vs. ProNamel Daily Protection

NET WT 3.0 OZ (85 g)

Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

Sensodyne ProNamelSTRONG & BrightENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

*vs. ProNamel Daily Protection

With twice daily brushing, the dual action formulation:

  • Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
  • Polishes away stains for WHITER BRIGHTER TEETH.

FRESHENSbreath and fights CAVITIES

GSKConsumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2017 GSK group of companies or its licensor.

ALWAYS FOLLOW THE LABEL

105488XC

105488XC_ProNamel Strong and Bright Enamel Extra Fresh_3 oz.JPG
105488XC_ProNamel Strong and Bright Enamel Extra Fresh_3 oz.JPG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN4
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD4
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY4
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0602-01Sensodyne PronamelStrong and Bright Enamel Mint1 in 1 CARTONPASTE14
0135-0602-01Sensodyne PronamelStrong and Bright Enamel Mint85 g in 1 TUBEPASTE854
0135-0602-02Sensodyne PronamelStrong and Bright Enamel Mint23 g in 1 TUBEPASTE234
0135-0602-02Sensodyne PronamelStrong and Bright Enamel Mint1 in 1 CARTONPASTE14
0135-0603-01Sensodyne PronamelStrong and Bright Enamel Extra Fresh85 g in 1 TUBEPASTE854
0135-0603-01Sensodyne PronamelStrong and Bright Enamel Extra Fresh1 in 1 CARTONPASTE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0602SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL EXTRA FRESH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 4 package rows20240308_be1ae382-0e01-4db8-90d7-fdadec2ff861.zip
0135-0603SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL EXTRA FRESH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 2 package rows20240308_be1ae382-0e01-4db8-90d7-fdadec2ff861.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0602-01GM - Gram0135-06027cc7805a-d7bf-42c4-9389-bcc89db44ba512017-03-06
0135-0603-01GM - Gram0135-0603b941f199-dbce-47eb-be5f-0ba10c97390012017-03-06

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06020135-0602-01, 0135-0602-02
0135-06030135-0603-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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

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 Strong and Bright Enamel MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCbe1ae382-0e01-4db8-90d7-fdadec2ff8612024-03-06WarningsExact identifier
ndc (package): 0135-0602-01
ndc (package): 0135-0603-01
ndc (package): 0135-0602-02
ndc (product): 0135-0602
ndc (product): 0135-0603
ndc11 (package): 00135060301
ndc11 (package): 00135060202
ndc11 (package): 00135060201
spl id: 13097a10-0813-22b5-e063-6294a90a9317
spl set id: be1ae382-0e01-4db8-90d7-fdadec2ff861

Reported adverse events (FAERS/openFDA)#

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