Home NDC 53942-581 Sodium fluoride
Product NDC 53942-581
11-digit product format 539420581
Labeler code 53942
Product ID 53942-581_49f0f3e2-248d-abb3-e063-6394a90aef6f
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form MOUTHWASH
Route ORAL
Labeler Demoulas Super Markets, Inc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-05
Substance SODIUM FLUORIDE
Active strength .2 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Sodium fluoride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .2 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 313029 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 53942-581-86 Sodium fluoride 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53942-581 SODIUM FLUORIDE MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 3 Current NDC, 1 package rows 20250515_2f5d3c75-1a11-47e1-b297-e2302177efe7.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 33 of 49 · 974 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 53942-581-86 53942058186 1000 mL in 1 BOTTLE, PLASTIC (53942-581-86) 1000 ml 2023-06-05 No No Current