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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-362	36800-362-00	D	Discontinued by firm		2026-10-15

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3012a8da-7595-2f7c-e063-6294a90ae120	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 11 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Total SF Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	3bba340e-2a62-3b04-41b5-0ed9c13adb13	2026-04-22	Warnings	Exact identifier application number: M021
EverSmile Squirt	SODIUM FLUORIDE 0.05%	Everbrands, Inc.	bc0ef174-2909-469a-b629-0eab4412bdfc	2026-04-20	Warnings	Exact identifier application number: M021
Gum Detoxify	STANNOUS FLUORIDE	Walmart	41d6cc7a-0b87-e474-e063-6294a90ae995	2026-04-20	Warnings	Exact identifier application number: M021
Eversmile Squirt	2.65% HYDROGEN PEROXIDE	Everbrands, Inc.	2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf	2026-04-19	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	H E B	8d40f693-083c-4eb6-9da1-42675d757e0e	2026-04-16	Warnings, Adverse reactions	Exact identifier application number: M021
Eversmile OrthoFoam Anticavity	0.05% SODIUM FLUORIDE RINSE	Everbrands, Inc.	9c12e792-94c8-4e29-9a54-e7e70aadade6	2026-04-16	Warnings	Exact identifier application number: M021
Eversmile Squirt	2.65% HYDROGEN PEROXIDE	Everbrands, Inc.	6753b426-6d49-4438-a52f-c28e60a0e9d8	2026-04-16	Warnings	Exact identifier application number: M021
Osstem G Gum Health Care Tooth	SODIUM FLUORIDE	Osstem Pharma Co., Ltd	4f8b4fc0-4c98-5e52-e063-6394a90af710	2026-04-15	Warnings	Exact identifier application number: M021
Crest 3D White Deep Stain Remover Enamel Strength	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	4f6b8851-c778-8abd-e063-6294a90aef4f	2026-04-14		Exact identifier application number: M021
Crest 3D White Stain Eraser Luxe Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6beb3b-2521-bfb7-e063-6394a90ad9ea	2026-04-14		Exact identifier application number: M021
Kids Crest Strawberry Rush	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d13	2026-04-14	Warnings	Exact identifier application number: M021
Crest Pro-Health Mouthwash Multi-Protection Strong Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6d11b2-5aa2-ab34-e063-6294a90ac0bc	2026-04-14	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Publix Super Markets, Inc.	cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb	2026-04-14	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Publix Super Markets, Inc.	f0e84078-499f-4a5a-bcd2-23f57805de86	2026-04-14	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Pro-Health Advanced Multi-Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	1cfc5b61-c8e5-943d-e063-6394a90a890b	2026-04-14	Warnings	Exact identifier application number: M021
Crest Pro-Health Multi-Protection plus Extra Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6f6299-f95f-2f0e-e063-6294a90a1641	2026-04-14	Warnings	Exact identifier application number: M021
Crest 3D White Strength Whitening Enamel Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f7125aa-3aa2-ca64-e063-6394a90a4cf3	2026-04-14	Warnings	Exact identifier application number: M021
Eversmile TheraFoam	0.05% SODIUM FLUORIDE RINSE	Everbrands, Inc.	57da2479-923a-45ec-8149-57b469b11637	2026-04-13	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Bacteria Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f1ce508-fe6e-4045-e063-6294a90ab3e2	2026-04-10	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitivity Relief	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	4f1d62ae-653e-3046-e063-6294a90abbf8	2026-04-10	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1086243	potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste	PSN	3012a8da-7595-2f7c-e063-6294a90ae120	4
1086243	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste	SCD	3012a8da-7595-2f7c-e063-6294a90ae120	4
1086243	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste	SY	3012a8da-7595-2f7c-e063-6294a90ae120	4
1086243	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste	SY	3012a8da-7595-2f7c-e063-6294a90ae120	4

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5820090 TopCare Enamel Guard Intensive (8015074)	Topco Associates LLC \| Lornamead Products \| Lornamead	2025-09-30	HUMAN OTC DRUG LABEL	4