Home NDC 0135-0701 SENSODYNE PRONAMEL
Product NDC 0135-0701
11-digit product format 001350701
Labeler code 0135
Product ID 0135-0701_12dd7448-a7e1-9b94-e063-6394a90a6d48
Type HUMAN OTC DRUG
Nonproprietary name potassium nitrate and sodium fluoride
Dosage form PASTE
Route ORAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-02
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 Active Shield Cool Mint
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 0135-0701-01 SENSODYNE PRONAMELActive Shield Cool Mint 96.4 g in 1 TUBE PASTE 96.4 4 0135-0701-01 SENSODYNE PRONAMELActive Shield Cool Mint 1 in 1 CARTON PASTE 1 4 0135-0701-02 SENSODYNE PRONAMELActive Shield Cool Mint 1 in 1 CARTON PASTE 1 4 0135-0701-02 SENSODYNE PRONAMELActive Shield Cool Mint 65.2 g in 1 TUBE PASTE 65.2 4 0135-0701-03 SENSODYNE PRONAMELActive Shield Cool Mint 96.4 g in 1 TUBE PASTE 96.4 4 0135-0701-03 SENSODYNE PRONAMELActive Shield Cool Mint 2 in 1 CARTON PASTE 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0701 SENSODYNE PRONAMEL ACTIVE SHIELD FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL ACTIVE SHIELD COOL MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 4 Current NDC, Legacy NDC, 6 package rows 20240306_e8684615-f544-4871-b935-0a0f93639d7d.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 40 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Iolite BENZOCAINE Dharma Research, Inc. e4b2d22b-00b3-45a6-9b7d-8ee719587059 2023-10-09 Warnings Exact identifier application number: M022 Iolite BENZOCAINE Dharma Research, Inc. a0e284f6-292f-4231-8596-f7cee4e0a12f 2023-10-09 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC fe92637a-c88a-f9dd-e053-6294a90a7fa3 2023-07-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC c979e958-2042-471a-bf03-e84e68620106 2023-06-20 Warnings Exact identifier application number: M022 Orajel Gum Pain 3X Medicated BENZOCAINE, MENTHOL, ZINC CHLORIDE Church & Dwight Co., Inc. 9a1632ad-2b47-5653-e053-2995a90ae0d9 2023-01-20 Warnings Exact identifier application number: M022 KOLORZ TOPICAL ANESTHETIC TRIPLE MINT BENZOCAINE DMG AMERICA, LLC 0f90b227-f938-4e1a-a79e-1967b1a0477e 2021-10-01 Warnings Exact identifier application number: M022
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 0135-0701-01 00135070101 1 TUBE in 1 CARTON (0135-0701-01) / 96.4 g in 1 TUBE 1 tube 2023-01-02 0000-00-00 No No Current 0135-0701-02 00135070102 1 TUBE in 1 CARTON (0135-0701-02) / 65.2 g in 1 TUBE 1 tube 2023-01-02 0000-00-00 No No Current 0135-0701-03 00135070103 2 TUBE in 1 CARTON (0135-0701-03) / 96.4 g in 1 TUBE 2 tube 2024-01-02 No No Current