Home NDC 0135-0811 Sensodyne Pronamel
Product NDC 0135-0811
11-digit product format 001350811
Labeler code 0135
Product ID 0135-0811_4124888c-4bab-f7b5-e063-6394a90a7532
Type HUMAN OTC DRUG
Nonproprietary name potassium nitrate, sodium fluoride
Dosage form PASTE
Route ORAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-06
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50; 1.15 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 Pronamel
Brand name suffix Clinical Enamel Strength Whitening Action
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g SODIUM FLUORIDE 1.15 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 0135-0811-02 Sensodyne PronamelClinical Enamel Strength Whitening Action 96.4 g in 1 TUBE PASTE 96.4 2 0135-0811-02 Sensodyne PronamelClinical Enamel Strength Whitening Action 1 in 1 CARTON PASTE 1 2 0135-0811-03 Sensodyne PronamelClinical Enamel Strength Whitening Action 1 in 1 CARTON PASTE 1 2 0135-0811-03 Sensodyne PronamelClinical Enamel Strength Whitening Action 65.2 g in 1 TUBE PASTE 65.2 2 0135-0811-23 Sensodyne PronamelClinical Enamel Strength Whitening Action 96.4 g in 1 TUBE PASTE 96.4 2 0135-0811-23 Sensodyne PronamelClinical Enamel Strength Whitening Action 2 in 1 CARTON PASTE 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0811 SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH WHITENING ACTION (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 1 Current NDC, 6 package rows 20250107_e8a62f24-1db6-45fb-b6e1-5e57103f82bc.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 9 of 40 · 786 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 0135-0811-02 00135081102 1 TUBE in 1 CARTON (0135-0811-02) / 96.4 g in 1 TUBE 1 tube 2025-01-06 No No Current 0135-0811-03 00135081103 1 TUBE in 1 CARTON (0135-0811-03) / 65.2 g in 1 TUBE 1 tube 2025-01-06 No No Current 0135-0811-23 00135081123 2 TUBE in 1 CARTON (0135-0811-23) / 96.4 g in 1 TUBE 2 tube 2025-12-01 No No Current