Home NDC 51316-128 CVS
Product NDC 51316-128
11-digit product format 513160128
Labeler code 51316
Product ID 51316-128_441c58b7-5448-ea10-e063-6394a90a244e
Type HUMAN OTC DRUG
Nonproprietary name Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler CVS Pharmacy
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-01-20
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength .15; 5 g/100g; 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 CVS
Brand name suffix Enamel Guard
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .15 g/100g POTASSIUM NITRATE 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038929 Internal RxNorm 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 51316-128-89 CVSEnamel Guard 113 g in 1 TUBE PASTE, DENTIFRICE 113 10 51316-128-89 CVSEnamel Guard 1 in 1 CARTON PASTE, DENTIFRICE 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-128 CVS ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY] 7 Current NDC, Legacy NDC, 2 package rows 20250119_d9dfa515-426b-9059-e053-2a95a90a3885.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 15 of 40 · 786 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 51316-128-89 51316012889 1 TUBE in 1 CARTON (51316-128-89) / 113 g in 1 TUBE 1 tube 2012-11-30 0000-00-00 No No Current