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 12 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Clean Breath Peppermint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f1ef07b-ee68-e6ae-e063-6394a90af5e5	2026-04-10	Warnings	Exact identifier application number: M021
Crest Clean Breath Spearmint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f20343e-6c03-48e8-e063-6294a90a8cdf	2026-04-10	Warnings	Exact identifier application number: M021
Crest Clean Breath Smooth Mint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f2042b4-8eae-5c2c-e063-6394a90a640c	2026-04-10	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Arctic Fresh with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef4146d-6281-fe66-e063-6394a90a32c3	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Glamorous White with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef5261e-9d2f-ae05-e063-6294a90a489a	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Luminous Mint Daily Whitening Upkeep	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f0876d9-41c9-d891-e063-6394a90a1cbd	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Charcoal with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef57a05-b9f5-42f7-e063-6294a90a5d89	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Radiant Mint with Stain Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ee26a82-16fd-f0fb-e063-6394a90a91d1	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Whitening Therapy Deep Clean Charcoal	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	812c1519-1a4b-2495-e053-2a91aa0a914a	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Deep Clean with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef4e7c2-1f58-59fc-e063-6294a90ad43b	2026-04-08	Warnings	Exact identifier application number: M021
Anticavity mouth rinse Low-foaming Spearmint	779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINT	Dyson Technology Limited	4ef669b9-defe-8965-e063-6394a90ab335	2026-04-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Radiant Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5c89efc-5fa0-2a05-e053-2a95a90a7b9c	2026-04-07	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Charcoal	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f4eb8111-53da-17ae-e053-2a95a90a1127	2026-04-07	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	ADUSA Distribution, LLC	35385ada-bd8d-4d38-9587-0256885f749f	2026-04-07	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	ADUSA Distribution, LLC	cf0c8b48-0d1c-406a-a67d-7d16187d38d8	2026-04-07	Warnings, Adverse reactions	Exact identifier application number: M021
Crest 3D White Arctic Fresh	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	fa08a877-b9e5-4eba-b832-3a28f4f3f83c	2026-04-07	Warnings	Exact identifier application number: M021
Anticavity Fluoride	SODIUM FLUORIDE	Family Dollar (FAMILY WELLNESS)	63c4c0e9-84b1-4076-bdf4-7e9543b2cf46	2026-04-01	Warnings	Exact identifier application number: M021
CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	98a8cee8-9f3c-4a4a-89f8-72e1f1b06796	2026-04-01	Warnings	Exact identifier application number: M021
CloSYS	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	5f87abb7-0e9d-6369-e053-2a91aa0a2411	2026-03-31	Warnings	Exact identifier application number: M021
Crest Clean Breath Spearmint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4e544d09-0cf3-f0c7-e063-6394a90a2369	2026-03-31	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