Home NDC 36800-362 Intensive Enamel Repair Whitening TP
Product NDC 36800-362
11-digit product format 368000362
Labeler code 36800
Product ID 36800-362_400555cb-e40f-5d08-e063-6394a90a160a
Type HUMAN OTC DRUG
Nonproprietary name Intensive Enamel Repair Whitening TP
Dosage form PASTE, DENTIFRICE
Route ORAL
Labeler Topco Associates LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-17
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 5; .15 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 36800-362 36800-362-00 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 Intensive Enamel Repair Whitening TP
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 5 g/100g SODIUM FLUORIDE .15 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup 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 1086243 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 36800-362-00 Intensive Enamel Repair Whitening TP 96.4 g in 1 TUBE PASTE, DENTIFRICE 96.4 4 36800-362-00 Intensive Enamel Repair Whitening TP 1 in 1 CARTON PASTE, DENTIFRICE 1 4 36800-362-10 Intensive Enamel Repair Whitening TP 1 in 1 CARTON PASTE, DENTIFRICE 1 4 36800-362-10 Intensive Enamel Repair Whitening TP 96.4 g in 1 TUBE PASTE, DENTIFRICE 96.4 4
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 33 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 36800-362-00 36800036200 96.4 g in 1 TUBE 96.4 g Historical 36800-362-10 36800036210 1 TUBE in 1 CARTON (36800-362-10) / 96.4 g in 1 TUBE 1 tube 2025-09-30 No No Current