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.
SENSODYNE PRONAMEL
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2024-03-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:09:23
Label at a glance#
ProductSENSODYNE PRONAMEL mineral BOOST refreshing peppermint
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure12 sections
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 ...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Potassium nitrate 5%
Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Purpose
Antihypersensitivity
Anticavity
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
Stop use and ask a dentist if
- 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.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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 information
- do not store above 25°C (77°F)
Inactive ingredients (refreshing peppermint)
water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin
Inactive ingredients (whitening action)
water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide
Questions or comments?
1-866-844-2797
Additional Information
Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide
Minerals keep enamel strong and white. But acidic foods & drinks can dissolve surface minerals. Your saliva naturally replenishes minerals but can’t always keep up, leading to enamel loss.
Pronamel Mineral Boost improves natural mineral absorption for strong white teeth, protected from sensitivity.
ACIDS DISSOLVE SURFACE MINERALS…
…PRONAMEL BOOSTS MINERAL ABSORPTION FROM SALIVA
Replenishes vital minerals in enamel.
Developed to maximize the effect of fluoride to boost the absorption of calcium & phosphate into the enamel surface.
With twice-daily brushing, Pronamel helps to:
- Protect against effects of dietary acids
- Prevent enamel loss
- Relieve sensitive teeth
- Protect against cavities
- Clean and freshen your mouth
Recyclable Carton
Save Water
Turn off tap while brushing
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
Principal Display Panel
NDC 0135-0450-01
SENSODYNE
PRONAMEL
MINERAL BOOST
new
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
Replenishes Vital Minerals
For Stronger, Healthier Enamel
infused with refreshing peppermint
NET WT 4.0 OZ (113g)
gsk
©2020 GSK group of companies or its licensor.
62000000049368
Principal Display Panel
NDC 0135-0480-01
SENSODYNE
PRONAMEL
MINERAL BOOST
new
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
Replenishes Vital Minerals
For Stronger, Healthier Enamel
With gentle whitening action
NET WT 4.0 OZ (113g)
gsk
©2020 GSK group of companies or its licensor.
62000000049369
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086243 | potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste | PSN | 2 |
| 1086243 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste | SCD | 2 |
| 1086243 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | 2 |
| 1086243 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | 2 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0450-01 | SENSODYNE PRONAMELmineral BOOST refreshing peppermint | 1 in 1 CARTON | PASTE | 1 | 2 | |
| 0135-0450-01 | SENSODYNE PRONAMELmineral BOOST refreshing peppermint | 118 g in 1 TUBE | PASTE | 118 | 2 | |
| 0135-0480-01 | SENSODYNE PRONAMELmineral BOOST whitening action | 118 g in 1 TUBE | PASTE | 118 | 2 | |
| 0135-0480-01 | SENSODYNE PRONAMELmineral BOOST whitening action | 1 in 1 CARTON | PASTE | 1 | 2 | |
| 0135-0480-02 | SENSODYNE PRONAMELmineral BOOST whitening action | 1 in 1 CARTON | PASTE | 1 | 2 | |
| 0135-0480-02 | SENSODYNE PRONAMELmineral BOOST whitening action | 77 g in 1 TUBE | PASTE | 77 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0450 | SENSODYNE PRONAMEL MINERAL BOOST REFRESHING PEPPERMINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MINERAL BOOST WHITENING ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 2 | Legacy NDC, 2 package rows | 20240306_b6b53ab0-82ee-459a-be1a-14e12c2582f5.zip |
| 0135-0480 | SENSODYNE PRONAMEL MINERAL BOOST REFRESHING PEPPERMINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MINERAL BOOST WHITENING ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 2 | Legacy NDC, 4 package rows | 20240306_b6b53ab0-82ee-459a-be1a-14e12c2582f5.zip |
Products#
Every source-derived product name is available through these pages.
- SENSODYNE PRONAMEL mineral BOOST refreshing peppermint
- potassium nitrate and sodium fluoride
- WATER
- SORBITOL
- HYDRATED SILICA
- GLYCERIN
- COCAMIDOPROPYL BETAINE
- XANTHAN GUM
- TITANIUM DIOXIDE
- SACCHARIN SODIUM
- POTASSIUM NITRATE
- NITRATE ION
- SODIUM FLUORIDE
- FLUORIDE ION
- SENSODYNE PRONAMEL mineral BOOST whitening action
- SODIUM HYDROXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0135-0450 | 0135-0450-01 |
| 0135-0480 | 0135-0480-01, 0135-0480-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 12df093e-d034-6f24-e063-6294a90acf44 | b6b53ab0-82ee-459a-be1a-14e12c2582f5 | 2024-03-04 | Warnings | 12df093e-d034-6f24-e063-6294a90acf44 b6b53ab0-82ee-459a-be1a-14e12c2582f5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.