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 31 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1ba491f4-2ad2-6e7b-e063-6394a90a9fb7 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 188ac743-3ba8-4da4-e063-6294a90a8f87 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b682604-c563-01f1-e063-6294a90ab0bd 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b110db1-fcc0-377f-e063-6394a90a4d44 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1b74ecc4-a1e6-348f-e063-6294a90a5894 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b68315c-6afa-3f37-e063-6294a90a14e8 2025-12-11 Warnings Exact identifier application number: M021 ANTICAVITY FLUORIDE SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 295b88e8-c4b5-c0b0-e063-6394a90aca01 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1b74f072-c33b-c6e2-e063-6394a90ab1e6 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1ba4a807-d6d5-04a0-e063-6294a90ae04d 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b617f4a-b56c-9f75-e063-6294a90a7abe 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b9ec370-eadf-92c4-e063-6294a90a9055 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVOR SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1eb04296-ecb1-3ccc-e063-6294a90a9bda 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b9e7b21-0d34-74ec-e063-6294a90a1f59 2025-12-11 Exact identifier application number: M021 Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash SODIUM FLUORIDE Kenvue Brands LLC 28986d7f-3e9a-8dfb-e063-6394a90a731e 2025-12-10 Warnings Exact identifier application number: M021 Toms of Maine Tropical Island ALUMINUM CHLOROHYDRATE Colgate-Palmolive Company 0d6c51bc-5391-4533-b4fd-961dc4f36342 2025-12-10 Warnings Exact identifier application number: M021 Business Class Kit SODIUM MONOFLUOROPHOSPHATE American Airlines, Inc. 483d7aec-34ac-49c5-ac0e-8fba5b4737ae 2025-12-09 Warnings Exact identifier application number: M021 Colgate Anticavity Kit SODIUM MONOFLUOROPHOSPHATE Ming Fai Industrial (Shenzhen) Co. Ltd 121decce-c364-4060-87da-0c6a6cd48474 2025-12-08 Warnings Exact identifier application number: M021 First Class Kit SODIUM MONOFLUOROPHOSPHATE American Airlines, Inc. ba717de8-c3a2-41bf-85a1-aa75f9744d30 2025-12-08 Warnings Exact identifier application number: M021 United Airlines Business Class Kit SODIUM MONOFLUOROPHOSPHATE United Airlines 94c5e9a4-19f3-4590-9da4-313c75261231 2025-12-08 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Nano-Hydroxyapatite SODIUM FLUORIDE Dr Jen Natural, LLC 5f08d994-e458-42b2-aa39-e84fca3acf48 2025-12-05 Warnings Exact identifier application number: M021
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