Home NDC 11344-004 Anticavity Fluoride Rinse
Product NDC 11344-004
11-digit product format 113440004
Labeler code 11344
Product ID 11344-004_59e0f541-aeac-02e8-e063-6294a90aa592
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form MOUTHWASH
Route ORAL
Labeler Nice-Pak Products, LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-29
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 Fluoride Rinse
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 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 11344-004-44 Anticavity Fluoride Rinse 532 mL in 1 BOTTLE, PLASTIC MOUTHWASH 532 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11344-004 ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CONSUMER PRODUCT PARTNERS, LLC] 3 Current NDC, 1 package rows 20250315_c71d4064-f938-477b-9346-eb38be65390d.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 Sample Exclude flag Status 11344-004-44 11344000444 532 mL in 1 BOTTLE, PLASTIC (11344-004-44) 532 ml 2024-02-29 No No Current