Sensodyne Pronamel

Product NDC
0135-0818
11-digit product format
001350818
Labeler code
0135
Product ID
0135-0818_4394cf17-0793-a5c9-e063-6294a90a73c0
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Haleon US Holdings LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-15
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sensodyne Pronamel
Brand name suffix
Kids Bubble Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0818-01Sensodyne PronamelKids Bubble Mint113 g in 1 TUBEPASTE, DENTIFRICE1132
0135-0818-01Sensodyne PronamelKids Bubble Mint1 in 1 CARTONPASTE, DENTIFRICE12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-0818-01001350818011 TUBE in 1 CARTON (0135-0818-01) / 113 g in 1 TUBE1 tube2025-12-15NoNoCurrent