Home NDC 0135-0808 Sensodyne Pronamel
Product NDC 0135-0808
11-digit product format 001350808
Labeler code 0135
Product ID 0135-0808_1f91320f-d81f-d5ef-e063-6394a90ad72d
Type HUMAN OTC DRUG
Nonproprietary name sodium fluoride
Dosage form PASTE
Route DENTAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-06
Substance SODIUM FLUORIDE
Active strength 1.1 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sensodyne Pronamel
Brand name suffix Kids Bubble Twist
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-0808-01 Sensodyne PronamelKids Bubble Twist 113 g in 1 TUBE PASTE 113 1 0135-0808-01 Sensodyne PronamelKids Bubble Twist 1 in 1 CARTON PASTE 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0808 SENSODYNE PRONAMEL KIDS BUBBLE TWIST (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 1 Current NDC, 2 package rows 20250107_e403529a-0fac-4dab-b75c-46906add096b.zip
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 27 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0135-0808-01 00135080801 1 TUBE in 1 CARTON (0135-0808-01) / 113 g in 1 TUBE 1 tube 2025-01-06 No No Current