FDA.reportPublic FDA data

Sensodyne Pronamel

Manufacturer
Haleon US Holdings LLC
Effective date
2024-08-13
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 Kids Bubble Twist
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. to minimize swallowing for children under 6 years of age, use a pea-sized amount and rinsing until good habits are established. children under 2 years of age: Consult a dentist ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.254% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

  • aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Keep out of the reach of children under 6 years of age.

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 2 years of age and older:
    • brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • to minimize swallowing for children under 6 years of age, use a pea-sized amount and rinsing until good habits are established.
  • children under 2 years of age:Consult a dentist or doctor.

Other information

SPL UNCLASSIFIED SECTION

  • do not store above 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, xanthan gum, flavor, sodium saccharin, sodium hydroxide, blue 1

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

ALWAYS FOLLOW THE LABEL

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FLUORIDE ANTICAVITY TOOTHPASTE

new HALEON

Sensodyne PRONAMEL

KIDS

Bubble Twist

24hr Cavity Protection*

2x Stronger Enamel Defense*

NET WT 4.0 OZ (113 g)

62000000212226 Carton Front

Sensodyne Pronamel Kidz 4.0 oz (113 g).jpg
Sensodyne Pronamel Kidz 4.0 oz (113 g).jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0808-01Sensodyne PronamelKids Bubble Twist113 g in 1 TUBEPASTE1131
0135-0808-01Sensodyne PronamelKids Bubble Twist1 in 1 CARTONPASTE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0808SENSODYNE PRONAMEL KIDS BUBBLE TWIST (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]1Current NDC, 2 package rows20250107_e403529a-0fac-4dab-b75c-46906add096b.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-08080135-0808-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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 Kids Bubble TwistSODIUM FLUORIDEHaleon US Holdings LLCe403529a-0fac-4dab-b75c-46906add096b2024-08-13WarningsExact identifier
ndc (package): 0135-0808-01
ndc (product): 0135-0808
ndc11 (package): 00135080801
spl id: 1f91320f-d81f-d5ef-e063-6394a90ad72d
spl set id: e403529a-0fac-4dab-b75c-46906add096b

Reported adverse events (FAERS/openFDA)#

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