Home NDC 36800-451 TopCare Sensitive
Product NDC 36800-451
11-digit product format 368000451
Labeler code 36800
Product ID 36800-451_47e517a4-25d4-4a28-e063-6294a90a3453
Type HUMAN OTC DRUG
Nonproprietary name Potassium nitrate, Sodium 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 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 TopCare Sensitive
Brand name suffix Extra Whitening
Listing expiration 2027-12-31 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 36800-451-59 TopCare SensitiveExtra Whitening 1 in 1 CARTON PASTE, DENTIFRICE 1 14 36800-451-59 TopCare SensitiveExtra Whitening 113 g in 1 TUBE PASTE, DENTIFRICE 113 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-451 TOPCARE SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC] 12 Current NDC, Legacy NDC, 2 package rows 20250119_835f41cf-e920-7df7-e053-2a91aa0a4479.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 9 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 36800-451-59 36800045159 1 TUBE in 1 CARTON (36800-451-59) / 113 g in 1 TUBE 1 tube 2011-01-20 0000-00-00 No No Current