Home NDC 36800-681 Top Care
Product NDC 36800-681
11-digit product format 368000681
Labeler code 36800
Product ID 36800-681_4395839a-f420-fe45-e063-6394a90a33d3
Type HUMAN OTC DRUG
Nonproprietary name Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler TOPCO Assoc. LLC
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 Top Care
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 36800-681-19 Top CareEnamel Guard 113 g in 1 TUBE PASTE, DENTIFRICE 113 9 36800-681-19 Top CareEnamel Guard 1 in 1 CARTON PASTE, DENTIFRICE 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POTASSIUM NITRATE ACTIVE INGREDIENT RU45X2JN0Z TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 FLUORIDE ION ACTIVE MOIETY Q80VPU408O TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 NITRATE ION ACTIVE MOIETY T93E9Y2844 TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 SODIUM METHYL COCOYL TAURATE INACTIVE INGREDIENT JVL98CG53G TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-681 TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 7 Current NDC, Legacy NDC, 2 package rows 20250119_8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c.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 36800-681-19 36800068119 1 TUBE in 1 CARTON (36800-681-19) / 113 g in 1 TUBE 1 tube 2012-11-20 0000-00-00 No No Current