Home NDC 0135-5022 SENSODYNE
Product NDC 0135-5022
11-digit product format 001355022
Labeler code 0135
Product ID 0135-5022_13128d65-3388-ef9b-e063-6394a90af6ff
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 2023-01-02
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 Gum and Enamel Mint
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 0135-5022-01 SENSODYNESensitivity Gum and Enamel Mint 1 in 1 CARTON PASTE 1 4 0135-5022-01 SENSODYNESensitivity Gum and Enamel Mint 96.4 g in 1 TUBE PASTE 96.4 4 0135-5022-02 SENSODYNESensitivity Gum and Enamel Mint 65.2 g in 1 TUBE PASTE 65.2 4 0135-5022-02 SENSODYNESensitivity Gum and Enamel Mint 1 in 1 CARTON PASTE 1 4 0135-5022-03 SENSODYNESensitivity Gum and Enamel Mint 2 in 1 CARTON PASTE 2 4 0135-5022-03 SENSODYNESensitivity Gum and Enamel Mint 96.4 g in 1 TUBE PASTE 96.4 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-5022 SENSODYNE SENSITIVITY GUM AND ENAMEL MINT (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 4 Current NDC, Legacy NDC, 6 package rows 20240308_d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2.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 14 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 0135-5022-01 00135502201 1 TUBE in 1 CARTON (0135-5022-01) / 96.4 g in 1 TUBE 1 tube 2023-01-02 0000-00-00 No No Current 0135-5022-02 00135502202 1 TUBE in 1 CARTON (0135-5022-02) / 65.2 g in 1 TUBE 1 tube 2023-01-02 0000-00-00 No No Current 0135-5022-03 00135502203 2 TUBE in 1 CARTON (0135-5022-03) / 96.4 g in 1 TUBE 2 tube 2024-01-02 No No Current