Home NDC 51316-163 OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVOR
Product NDC 51316-163
11-digit product format 513160163
Labeler code 51316
Product ID 51316-163_d0a47ca3-2643-4cb9-9574-1101d7b6e539
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler CVS Pharmacy, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-30
Substance SODIUM FLUORIDE
Active strength .243 g/100g
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 OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVOR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .243 g/100g
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 891775 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 51316-163-01 OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVOR 130 g in 1 TUBE PASTE, DENTIFRICE 130 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-163 OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY, INC.] 3 Current NDC, 1 package rows 20241019_17f589e9-f4ba-46d3-a345-db38f9a9067d.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 51316-163-01 51316016301 130 g in 1 TUBE (51316-163-01) 130 g 2024-09-30 No No Current