Home NDC 0135-0449 SENSODYNE PRONAMEL
Product NDC 0135-0449
11-digit product format 001350449
Labeler code 0135
Product ID 0135-0449_0a03a9b2-cbbd-4b73-91db-aea9d3a32264
Type HUMAN OTC DRUG
Nonproprietary name sodium fluoride
Dosage form LIQUID
Route ORAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-02
Substance SODIUM FLUORIDE
Active strength .5 mg/mL
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 Intensive Enamel Repair Clean Mint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 240698 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 0135-0449-01 SENSODYNE PRONAMELIntensive Enamel Repair Clean Mint 500 mL in 1 BOTTLE LIQUID 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0449 SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR CLEAN MINT (SODIUM FLUORIDE) LIQUID SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR EXTRA FRESH (SODIUM FLUORIDE) LIQUID [HALEON US HOLDINGS LLC] 3 Current NDC, 1 package rows 20241030_817c0dad-d109-428e-adb5-3354604acc94.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 0135-0449-01 00135044901 500 mL in 1 BOTTLE (0135-0449-01) 500 ml 2024-01-02 No No Current