Home NDC 0135-5025 SENSODYNE
Product NDC 0135-5025
11-digit product format 001355025
Labeler code 0135
Product ID 0135-5025_13123f95-ce72-c317-e063-6394a90ac2d2
Type HUMAN OTC DRUG
Nonproprietary name stannous fluoride
Dosage form PASTE
Route ORAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-06
Substance STANNOUS 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
Brand name suffix SENSITIVITY AND GUM CLEAN AND FRESH
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS 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 3FTR44B32Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416784 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 0135-5025-01 SENSODYNESENSITIVITY AND GUM CLEAN AND FRESH 96.4 g in 1 TUBE PASTE 96.4 6 0135-5025-01 SENSODYNESENSITIVITY AND GUM CLEAN AND FRESH 1 in 1 CARTON PASTE 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-5025 SENSODYNE SENSITIVITY AND GUM MINT (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM WHITENING (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM CLEAN AND FRESH (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 6 Current NDC, Legacy NDC, 2 package rows 20240308_ed093acd-255c-40ff-a010-d276f5844453.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 0135-5025-01 00135502501 1 TUBE in 1 CARTON (0135-5025-01) / 96.4 g in 1 TUBE 1 tube 2021-01-06 0000-00-00 No No Current