Home NDC 0135-0580 Sensodyne Pronamel
Product NDC 0135-0580
11-digit product format 001350580
Labeler code 0135
Product ID 0135-0580_ae922167-f3d1-461d-9233-114b01b349c1
Type HUMAN OTC DRUG
Nonproprietary name potassium nitrate and sodium fluoride
Dosage form PASTE
Route DENTAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-15
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 Gentle Whitening Advanced
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-0580-01 Sensodyne PronamelGentle Whitening Advanced 184 g in 1 TUBE PASTE 184 5 0135-0580-01 Sensodyne PronamelGentle Whitening Advanced 1 in 1 CARTON PASTE 1 5 0135-0580-02 Sensodyne PronamelGentle Whitening Advanced 4 in 1 CARTON PASTE 4 5 0135-0580-02 Sensodyne PronamelGentle Whitening Advanced 184 g in 1 TUBE PASTE 184 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0580 SENSODYNE PRONAMEL GENTLE WHITENING ADVANCED (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 5 Current NDC, Legacy NDC, 4 package rows 20240906_94e07979-943b-45bb-8e2b-90d686f3692e.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 Marketing end Sample Exclude flag Status 0135-0580-01 00135058001 1 TUBE in 1 CARTON (0135-0580-01) / 184 g in 1 TUBE 1 tube 2021-03-15 0000-00-00 No No Current 0135-0580-02 00135058002 4 TUBE in 1 CARTON (0135-0580-02) / 184 g in 1 TUBE 4 tube 2023-07-01 No No Current