FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-36236800-362-00DDiscontinued by firm2026-10-16

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage36800-36236800-362-00DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…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
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE.15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086243Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3012a8da-7595-2f7c-e063-6294a90ae120Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-362-00Intensive Enamel Repair Whitening TP96.4 g in 1 TUBEPASTE, DENTIFRICE96.44
36800-362-00Intensive Enamel Repair Whitening TP1 in 1 CARTONPASTE, DENTIFRICE14
36800-362-10Intensive Enamel Repair Whitening TP1 in 1 CARTONPASTE, DENTIFRICE14
36800-362-10Intensive Enamel Repair Whitening TP96.4 g in 1 TUBEPASTE, DENTIFRICE96.44

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 47 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dentalclean Blue Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1881658c-e371-5513-e063-6394a90a465f2024-05-15WarningsExact identifier
application number: M021
Dentalclean Dr. Duck Strawberry flouride MouthwashSODIUM FLUORIDE 0.02%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1882c82a-3a32-5656-e063-6394a90ae0ed2024-05-15WarningsExact identifier
application number: M021
Dentalclean Booster KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186ecaeb-9401-9315-e063-6394a90a8e202024-05-14WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA ATTITUDEfefc1060-e1a4-4686-a8d8-84bf1e613abe2024-05-14WarningsExact identifier
application number: M021
Dentalclean Doctor DuckSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186f2f12-279f-32df-e063-6394a90ad53d2024-05-14WarningsExact identifier
application number: M021
Barbie Bubble Gum ANTICAVITY FLUORIDESODIUM FLUORIDEAshtel Studios Inc.dc5489e9-eeff-4db5-8793-21fb5bf4b2ef2024-05-10WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f31b5e-dd3b-78df-e063-6294a90a43ab2024-05-08WarningsExact identifier
application number: M021
Dentalclean Dental Gel Booster Adult UseSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f3981f-ab4b-0dcd-e063-6294a90a37d92024-05-08WarningsExact identifier
application number: M021
Dentalclean Sensitive PlusSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e0dc93-97bf-7f05-e063-6294a90a9a8b2024-05-07WarningsExact identifier
application number: M021
Dentalclean Whitening MaxSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e2364e-2511-3021-e063-6294a90a40e12024-05-07WarningsExact identifier
application number: M021
DeCureSODIUM MONOFLUOROPHOSPHATEScope medical devices private limited590c4827-f036-45bd-af30-0a4853ca34472024-05-07WarningsExact identifier
application number: M021
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf2024-04-22WarningsExact identifier
application number: M021
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db2024-04-19WarningsExact identifier
application number: M021
Toothpaste, plus ToothbrushSODIUM FLUORIDE PASTE, DENTIFRICE AND TOOTHBRUSHLil' Drug Store Products, Inc.15ac00f8-da51-6cea-e063-6294a90aeb812024-04-09WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDELG H&H Co.,Ltd.14ea1776-ef7f-27a9-e063-6394a90afd492024-03-29WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.14eb9f74-e5f5-e199-e063-6394a90adbf62024-03-29WarningsExact identifier
application number: M021
Dentalclean Ultra Refreshing Extreme Ice Dental GelSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1496636d-6563-d474-e063-6394a90ab73d2024-03-26WarningsExact identifier
application number: M021
Scope Stay StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company142bffe1-1e8c-8567-e063-6394a90af15a2024-03-21WarningsExact identifier
application number: M021
Made by Dentists Ultra Whitening Fresh MintSODIUM FLUORIDEMADE BY DENTISTS INCdbce2aba-48db-4e78-bf79-74f34868ee372024-03-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.13907bf6-9a95-c0b2-e063-6394a90a40422024-03-13WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN3012a8da-7595-2f7c-e063-6294a90ae1204
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD3012a8da-7595-2f7c-e063-6294a90ae1204
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY3012a8da-7595-2f7c-e063-6294a90ae1204
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY3012a8da-7595-2f7c-e063-6294a90ae1204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
36800-362-003680003620096.4 g in 1 TUBE96.4 gHistorical
36800-362-10368000362101 TUBE in 1 CARTON (36800-362-10) / 96.4 g in 1 TUBE1 tube2025-09-30NoNoCurrent