Home NDC 63615-000 Cavity Protection Fresh Mint
Product NDC 63615-000
11-digit product format 636150000
Labeler code 63615
Product ID 63615-000_0888b5f3-0425-f641-e063-6394a90a89c2
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Oxyfresh Worldwide Inc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-05-23
Substance SODIUM FLUORIDE
Active strength 2.35 mg/g
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 Cavity Protection Fresh Mint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 2.35 mg/g
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 1489127 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 63615-000-01 Cavity Protection Fresh Mint 1 in 1 CARTON PASTE, DENTIFRICE 1 2 63615-000-01 Cavity Protection Fresh Mint 142 g in 1 TUBE PASTE, DENTIFRICE 142 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63615-000 CAVITY PROTECTION FRESH MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [OXYFRESH WORLDWIDE INC] 2 Current NDC, Legacy NDC, 2 package rows 20231026_0ae98f28-7e78-4379-93b0-4f2657415c4d.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 63615-000-01 63615000001 1 TUBE in 1 CARTON (63615-000-01) / 142 g in 1 TUBE 1 tube 2014-05-23 0000-00-00 No No Current