Home NDC 53942-004 Anticavity Rinse
Product NDC 53942-004
11-digit product format 539420004
Labeler code 53942
Product ID 53942-004_5c8d9039-0701-a909-e063-6394a90af07f
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 2013-05-08
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 Anticavity Rinse
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .2 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53942-004-44 Anticavity Rinse 532 mL in 1 BOTTLE, PLASTIC MOUTHWASH 532 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53942-004 ANTICAVITY RINSE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 13 Current NDC, Legacy NDC, 1 package rows 20250309_6391ca2e-10e8-429d-a873-238a515f9c60.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 5 of 50 · 995 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 53942-004-44 53942000444 532 mL in 1 BOTTLE, PLASTIC (53942-004-44) 532 ml 2013-05-08 0000-00-00 No No Current