SENSODYNE PRONAMEL

Manufacturer
Haleon US Holdings LLC
Effective date
2024-01-24
Label type
HUMAN OTC DRUG LABEL
Version
21
Source
full-release
Hydrated at
2026-06-01 00:07:52

Key Label Information#

Active Ingredients And Purpose

Active ingredients

Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity Anticavity

Uses

Uses

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

Directions And Dosage

Directions

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 Label Information

Other information (Gentle Whitening, Daily Protection, Fresh Breath, Multi-Action)

do not store above 30°C (86°F)

Inactive ingredients (Gentle Whitening)

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

Inactive ingredients (Daily Protection)

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

Inactive ingredients (Fresh Breath)

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

Label Images#

Sensodyne Gentle Whitening 6.5 OZ(184 g).JPG.jpg.jpg.jpg
Sensodyne Gentle Whitening 6.5 OZ(184 g).JPG.jpg.jpg.jpg
Sensodyne Daily Protection 4.0 OZ(113 g).jpg.jpg.jpg.jpg
Sensodyne Daily Protection 4.0 OZ(113 g).jpg.jpg.jpg.jpg
Sensodyne Fresh Breath 4.0 OZ(113 g).JPG.jpg.jpg.jpg
Sensodyne Fresh Breath 4.0 OZ(113 g).JPG.jpg.jpg.jpg
Sensodyne Multi-Action 4.0 OZ(113 g).jpg.jpg.jpg.jpg
Sensodyne Multi-Action 4.0 OZ(113 g).jpg.jpg.jpg.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN21
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD21
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY21
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY21

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0460-01SENSODYNE PRONAMELDaily Protection1 in 1 CARTONPASTE121
0135-0460-01SENSODYNE PRONAMELDaily Protection113 g in 1 TUBEPASTE11321
0135-0460-03SENSODYNE PRONAMELDaily Protection1 in 1 CARTONPASTE121
0135-0460-03SENSODYNE PRONAMELDaily Protection184.3 g in 1 TUBEPASTE184.321
0135-0460-06SENSODYNE PRONAMELDaily Protection2 in 1 CARTONPASTE221
0135-0460-06SENSODYNE PRONAMELDaily Protection113 g in 1 TUBEPASTE11321
0135-0484-01SENSODYNE PRONAMELGentle Whitening1 in 1 CARTONPASTE121
0135-0484-01SENSODYNE PRONAMELGentle Whitening113 g in 1 TUBEPASTE11321
0135-0484-02SENSODYNE PRONAMELGentle Whitening1 in 1 CARTONPASTE121
0135-0484-02SENSODYNE PRONAMELGentle Whitening76.5 g in 1 TUBEPASTE76.521
0135-0484-03SENSODYNE PRONAMELGentle Whitening22.6 g in 1 TUBEPASTE22.621
0135-0484-04SENSODYNE PRONAMELGentle Whitening1 in 1 CARTONPASTE121
0135-0484-04SENSODYNE PRONAMELGentle Whitening184.3 g in 1 TUBEPASTE184.321
0135-0484-05SENSODYNE PRONAMELGentle Whitening2 in 1 CARTONPASTE221
0135-0484-05SENSODYNE PRONAMELGentle Whitening113 g in 1 TUBEPASTE11321
0135-0484-06SENSODYNE PRONAMELGentle Whitening184.3 g in 1 TUBEPASTE184.321
0135-0484-06SENSODYNE PRONAMELGentle Whitening4 in 1 CARTONPASTE421
0135-0520-01SENSODYNE PRONAMELFresh Breath1 in 1 CARTONPASTE121
0135-0520-01SENSODYNE PRONAMELFresh Breath113 g in 1 TUBEPASTE11321
0135-0520-02SENSODYNE PRONAMELFresh Breath23 g in 1 TUBEPASTE2321
0135-0520-05SENSODYNE PRONAMELFresh Breath2 in 1 CARTONPASTE221
0135-0520-05SENSODYNE PRONAMELFresh Breath113 g in 1 TUBEPASTE11321
0135-0520-06SENSODYNE PRONAMELFresh Breath1 in 1 CARTONPASTE121
0135-0520-06SENSODYNE PRONAMELFresh Breath77 g in 1 TUBEPASTE7721
0135-0568-04SENSODYNE PRONAMELMulti Action113 g in 1 TUBEPASTE11321
0135-0568-04SENSODYNE PRONAMELMulti Action1 in 1 CARTONPASTE121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0460SENSODYNE PRONAMEL GENTLE WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL DAILY PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL FRESH BREATH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MULTI ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]21Current NDC, Legacy NDC, 6 package rows20240125_edffce4d-108b-4ffd-9adf-e12cb42ffddd.zip
0135-0484SENSODYNE PRONAMEL GENTLE WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL DAILY PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL FRESH BREATH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MULTI ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]21Current NDC, Legacy NDC, 11 package rows20240125_edffce4d-108b-4ffd-9adf-e12cb42ffddd.zip
0135-0520SENSODYNE PRONAMEL GENTLE WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL DAILY PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL FRESH BREATH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MULTI ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]21Current NDC, Legacy NDC, 7 package rows20240125_edffce4d-108b-4ffd-9adf-e12cb42ffddd.zip
0135-0568SENSODYNE PRONAMEL GENTLE WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL DAILY PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL FRESH BREATH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MULTI ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]21Current NDC, Legacy NDC, 2 package rows20240125_edffce4d-108b-4ffd-9adf-e12cb42ffddd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0484-02GM - Gram0135-048466d6ea4d-2c37-4d94-86ec-bf5e3493d44a12025-09-12
0135-0484-03GM - Gram0135-0484724e25a8-6f21-4997-af71-c3dcc76b0fca12024-09-09
0135-0460-01GM - Gram0135-0460941b8275-1b21-4ad5-8675-3fb9141a592f12024-04-05
0135-0460-06GM - Gram0135-0460b9f84b83-39fd-42e0-a6d3-9446f436c53112025-07-08
0135-0520-01GM - Gram0135-0520c2190fd7-ded1-4129-bfa5-02973c82f4f112024-04-05
0135-0520-02GM - Gram0135-052050f8a8c0-580c-4557-97bf-559cd008aedb12024-04-05
0135-0520-05GM - Gram0135-05206fce3414-6b80-48bd-9898-34b66c7bff9f12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0Z10
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W710
FLUORIDE IONACTIVE MOIETYQ80VPU408O10
NITRATE IONACTIVE MOIETYT93E9Y284410
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX10
GLYCERININACTIVE INGREDIENTPDC6A3C0OX10
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P910
MICAINACTIVE INGREDIENTV8A1AW088010
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ10
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I10
SORBITOLINACTIVE INGREDIENT506T60A25R10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP10
WATERINACTIVE INGREDIENT059QF0KO0R10
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE10

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-04840135-0484-01, 0135-0484-05, 0135-0484-02, 0135-0484-03, 0135-0484-04, 0135-0484-06
0135-04600135-0460-01, 0135-0460-06, 0135-0460-03
0135-05200135-0520-01, 0135-0520-02, 0135-0520-05, 0135-0520-06
0135-05680135-0568-04

Ingredients#

Complete SPL Sections#

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

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 (Gentle Whitening, Daily Protection, Fresh Breath, Multi-Action)

STORAGE AND HANDLING SECTION

do not store above 30°C (86°F)

Inactive ingredients (Gentle Whitening)

INACTIVE INGREDIENT SECTION

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

Inactive ingredients (Daily Protection)

INACTIVE INGREDIENT SECTION

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

Inactive ingredients (Fresh Breath)

INACTIVE INGREDIENT SECTION

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

Inactive ingredients (Multi-Action)

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0484-01 SENSODYNE PRONAMEL TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION Alpine Breeze GENTLE WHITENING Specialist Enamel Protection Rebuilds, Restores, Refreshes NET WT 4.0 OZ (113g) ALWAYS FOLLOW THE LABEL SENSODYNE PRONAMEL Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth. ACID ATTACKS ENAMEL WEAKENING THE ENAMEL STRUCTURE PRONAMEL REBUILDS & RESTORES ENAMEL FOR STRONG HEALTHY TEETH 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. With twice-daily brushing, Pronamel helps to: Rebuild enamel strength for strong, healthy teeth Protect against the effects of dietary acids Relieve sensitive teeth Freshen breath Protect against cavities Recycle Carton, Tube and Cap† Save Water Turn off tap while brushing †Recycling facilities for this product may not exist in your area Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2021 GSK group of companies or its licensor. 62000000068970 Front Carton

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0460-01 SENSODYNE PRONAMEL TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION Mint Essence DAILY PROTECTION Specialist Enamel Protection Rebuilds, Restores, Refreshes NET WT 4.0 OZ (113 g) ALWAYS FOLLOW THE LABEL SENSODYNE PRONAMEL Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth. ACID ATTACKS ENAMEL WEAKENING THE ENAMEL STRUCTURE PRONAMEL REBUILDS & RESTORES ENAMEL FOR STRONG HEALTHY TEETH 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. With twice-daily brushing, Pronamel helps to: Rebuild enamel strength for strong, healthy teeth Protect against the effects of dietary acids Relieve sensitive teeth Freshen breath Protect against cavities Recycle Carton, Tube and Cap† Save Water Turn off tap while brushing †Recycling facilities for this product may not exist in your area Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2021 GSK group of companies or its licensor. 62000000068992 Front Carton

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0520-01 SENSODYNE PRONAMEL TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION Fresh Wave FRESH BREATH Specialist Enamel Protection Rebuilds, Restores, Refreshes NET WT 4.0 OZ (113 g) ALWAYS FOLLOW THE LABEL SENSODYNE PRONAMEL Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth. ACID ATTACKS ENAMEL WEAKENING THE ENAMEL STRUCTURE PRONAMEL REBUILDS & RESTORES ENAMEL FOR STRONG HEALTHY TEETH 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. With twice-daily brushing, Pronamel helps to: Rebuild enamel strength for strong, healthy teeth Protect against the effects of dietary acids Relieve sensitive teeth Freshen breath Protect against cavities Recycle Carton, Tube and Cap† Save Water Turn off tap while brushing †Recycling facilities for this product may not exist in your area Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2021 GSK group of companies or its licensor. 62000000068910 Front Carton

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0568-04 SENSODYNE PRONAMEL TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION Cleansing Mint MULTI-ACTION Specialist Enamel Protection Rebuilds, Restores, Refreshes NET WT 4.0 OZ (113 g) ALWAYS FOLLOW THE LABEL SENSODYNE PRONAMEL Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth. ACID ATTACKS ENAMEL WEAKENING THE ENAMEL STRUCTURE PRONAMEL REBUILDS & RESTORES ENAMEL FOR STRONG HEALTHY TEETH 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. With twice-daily brushing, Pronamel helps to: Rebuild enamel strength for strong, healthy teeth Protect against the effects of dietary acids Relieve sensitive teeth Freshen breath Protect against cavities Recycle Carton, Tube and Cap† Save Water Turn off tap while brushing Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2021 GSK group of companies or its licensor. 62000000069352 Front Carton

Source Document#

Source XML