Home NDC 0135-7753 Sensodyne
Product NDC 0135-7753
11-digit product format 001357753
Labeler code 0135
Product ID 0135-7753_42f3ff91-2b4f-ec25-e063-6294a90a250e
Type HUMAN OTC DRUG
Nonproprietary name potassium nitrate, sodium fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Haleon US Holdings LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-01
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50; 1.5 mg/g; 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
Brand name suffix Pronamel Clinical Enamel Strength Fresh Breath
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g SODIUM FLUORIDE 1.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086243 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-7753-01 SensodynePronamel Clinical Enamel Strength Fresh Breath 1 in 1 CARTON PASTE, DENTIFRICE 1 2 0135-7753-01 SensodynePronamel Clinical Enamel Strength Fresh Breath 96.4 g in 1 TUBE PASTE, DENTIFRICE 96.4 2
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 30 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0135-7753-01 00135775301 1 TUBE in 1 CARTON (0135-7753-01) / 96.4 g in 1 TUBE 1 tube 2025-12-01 No No Current