FDA.reportPublic FDA data

SENSODYNE PRONAMEL

Manufacturer
Haleon US Holdings LLC
Effective date
2026-03-09
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:49:20

Label at a glance#

ProductSENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure11 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

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 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, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0492-01

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

CLEAN MINT

Repairs Weakened Enamel*

For Strong, Healthy Teeth

NET WT 3.4 OZ (96.4 g)

SENSODYNEPRONAMEL

INTENSIVE ENAMEL REPAIR

* Sensodyne Pronamel Intensive Enamel Repairis proven to drive minerals deepinto the enamel surface to help actively repairacid-weakened areas of the enamel, for stronger, better-protected teeth.

PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

LOCKS IN MINERALS

FOR STRONG HEALTHY TEETH

Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future.

With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to:

  • Actively repair acid-weakened enamel
  • Lock in minerals to protect against the effects of acid wear
  • Protect against cavities

Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

Recycle Carton, Tube and Cap

Save Water Turn off tap while brushing

ALWAYS FOLLOW THE LABEL

Trademarks owned or licensed by GSK. ©2022 GSK or licensor.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

62000000069608 Front Carton

Sensodyne Pronamel Intensive Enamel Repair Clean Mint
Sensodyne Pronamel Intensive Enamel Repair Clean Mint

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0486-01

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

EXTRA FRESH

Repairs Weakened Enamel*

For Strong, Healthy Teeth

NET WT 3.4 OZ (96.4 g)

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

* Sensodyne Pronamel Intensive Enamel Repairis proven to drive minerals deepinto the enamel surface to help actively repairacid-weakened areas of the enamel, for stronger, better-protected teeth.

PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

LOCKS IN MINERALS

FOR STRONG HEALTHY TEETH

Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future.

With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to:

  • Actively repair acid-weakened enamel
  • Lock in minerals to protect against the effects of acid wear
  • Protect against cavities

Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

Recycle Carton, Tube and Cap

Save Water Turn off tap while brushing

ALWAYS FOLLOW THE LABEL

Trademarks owned or licensed by GSK. ©2022 GSK or licensor.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

62000000068911 Front Carton

Sensodyne Pronamel Intensive Enamel Repair Extra Fresh
Sensodyne Pronamel Intensive Enamel Repair Extra Fresh

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0481-01

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

WHITENING ARTIC BREEZE

Repairs Weakened Enamel*

For Strong, Healthy Teeth

NET WT 3.4 OZ (96.4 g)

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

WHITENING

* Sensodyne Pronamel Intensive Enamel Repairis proven to drive minerals deepinto the enamel surface to help actively repairacid-weakened areas of the enamel, for stronger, better-protected teeth.

PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

LOCKS IN MINERALS

FOR STRONG HEALTHY TEETH

Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future.

With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to:

  • Actively repair acid-weakened enamel
  • Lock in minerals to protect against the effects of acid wear
  • Protect against cavities

Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

Recycle Carton, Tube and Cap

Save Water Turn off tap while brushing

ALWAYS FOLLOW THE LABEL

Trademarks owned or licensed by GSK. ©2022 GSK or licensor.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

62000000068993 Front Carton

Sensodyne Pronamel Intensive Enamel Repair Whitening
Sensodyne Pronamel Intensive Enamel Repair Whitening

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN10
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD10
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY10
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY10

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
0135-0481-01SENSODYNE PRONAMELIntensive Enamel Repair Whitening1 in 1 CARTONPASTE110
0135-0481-01SENSODYNE PRONAMELIntensive Enamel Repair Whitening96.4 g in 1 TUBEPASTE96.410
0135-0481-02SENSODYNE PRONAMELIntensive Enamel Repair Whitening96.4 g in 1 TUBEPASTE96.410
0135-0481-02SENSODYNE PRONAMELIntensive Enamel Repair Whitening2 in 1 CARTONPASTE210
0135-0481-04SENSODYNE PRONAMELIntensive Enamel Repair Whitening65 g in 1 TUBEPASTE6510
0135-0481-04SENSODYNE PRONAMELIntensive Enamel Repair Whitening1 in 1 CARTONPASTE110
0135-0486-01SENSODYNE PRONAMELIntensive Enamel Repair Extra Fresh1 in 1 CARTONPASTE110
0135-0486-01SENSODYNE PRONAMELIntensive Enamel Repair Extra Fresh96.4 g in 1 TUBEPASTE96.410
0135-0486-02SENSODYNE PRONAMELIntensive Enamel Repair Extra Fresh2 in 1 CARTONPASTE210
0135-0486-02SENSODYNE PRONAMELIntensive Enamel Repair Extra Fresh96.4 g in 1 TUBEPASTE96.410
0135-0492-01SENSODYNE PRONAMELIntensive Enamel Repair Clean Mint1 in 1 CARTONPASTE110
0135-0492-01SENSODYNE PRONAMELIntensive Enamel Repair Clean Mint96.4 g in 1 TUBEPASTE96.410
0135-0492-02SENSODYNE PRONAMELIntensive Enamel Repair Clean Mint1 in 1 CARTONPASTE110
0135-0492-02SENSODYNE PRONAMELIntensive Enamel Repair Clean Mint23 g in 1 TUBEPASTE2310
0135-0492-03SENSODYNE PRONAMELIntensive Enamel Repair Clean Mint23 g in 1 TUBEPASTE2310

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
0135-04920135-0492-01, 0135-0492-02, 0135-0492-03
0135-04860135-0486-01, 0135-0486-02
0135-04810135-0481-01, 0135-0481-02, 0135-0481-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM LACTATETU7HW0W0QTIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM LACTATETU7HW0W0QTIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM LACTATETU7HW0W0QTIACT
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 Intensive Enamel Repair WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCa2f9d58b-671b-4427-a971-1fceff5f23232026-03-09WarningsExact identifier
ndc (package): 0135-0492-03
ndc (package): 0135-0481-01
ndc (package): 0135-0481-04
ndc (package): 0135-0481-02
ndc (package): 0135-0492-01
ndc (package): 0135-0486-01
ndc (package): 0135-0492-02
ndc (package): 0135-0486-02
ndc (product): 0135-0481
ndc (product): 0135-0486
ndc (product): 0135-0492
ndc11 (package): 00135048601
ndc11 (package): 00135048602
ndc11 (package): 00135049203
ndc11 (package): 00135048101
ndc11 (package): 00135049202
ndc11 (package): 00135049201
ndc11 (package): 00135048102
ndc11 (package): 00135048104
spl id: 4c9ab9d6-fc06-eea3-e063-6394a90a5939
spl set id: a2f9d58b-671b-4427-a971-1fceff5f2323

Reported adverse events (FAERS/openFDA)#

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