Home NDC 55319-807 Anticavity Fluoride
Product NDC 55319-807
11-digit product format 553190807
Labeler code 55319
Product ID 55319-807_55150efe-465e-4f46-ab4e-c75b2b085a46
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form MOUTHWASH
Route DENTAL
Labeler Family Dollar (FAMILY WELLNESS)
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-01
Substance SODIUM FLUORIDE
Active strength .05 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 Fluoride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .05 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 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 55319-807-18 Anticavity Fluoride 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 4
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 45 of 50 · 995 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55319-807-18 55319080718 500 mL in 1 BOTTLE, PLASTIC (55319-807-18) 500 ml 2025-10-01 No No Current