TopCare Sensitive

Product NDC: 36800-451
11-digit product format: 368000451
Labeler code: 36800
Product ID: 36800-451_47e517a4-25d4-4a28-e063-6294a90a3453
Type: HUMAN OTC DRUG
Nonproprietary name: Potassium nitrate, Sodium fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: TOPCO Assoc. LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-01-20
Substance: SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength: .15; 5 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: TopCare Sensitive
Brand name suffix: Extra Whitening
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.15 g/100g
POTASSIUM NITRATE	5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup
RU45X2JN0Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1038929	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
835f41cf-e920-7df7-e053-2a91aa0a4479	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-451-59	TopCare SensitiveExtra Whitening	1 in 1 CARTON	PASTE, DENTIFRICE	1		14
36800-451-59	TopCare SensitiveExtra Whitening	113 g in 1 TUBE	PASTE, DENTIFRICE	113		14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-451	TOPCARE SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	12	Current NDC, Legacy NDC, 2 package rows	20250119_835f41cf-e920-7df7-e053-2a91aa0a4479.zip

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 10 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Pro-Health Breath Purify and Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d71ed31f-cc33-2fc3-e053-2995a90ad39b	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Clinical	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	0a295ee0-55c2-4f21-8f0a-70efc0e51694	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d721e2cb-8f67-3d07-e053-2995a90ae65a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Advantage	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	ddcd56fe-25d6-8195-e053-2a95a90a575a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Bacteria Guard	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c2dc1f31-625d-a032-e053-2995a90a730d	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro Health Gum plus Bacteria Guard	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c598a4ab-5981-0068-e053-2a95a90af4fa	2026-01-08	Warnings	Exact identifier application number: M022
Oral B Gum Detoxify Special Care Rinse	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c2dcdde4-5542-1f87-e053-2995a90a261c	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Intense Fresh Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	62991165-ec81-48a8-e053-2991aa0a54f3	2026-01-08	Warnings	Exact identifier application number: M022
Crest Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	72f1a02f-1d02-7e83-e053-2a91aa0a7947	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Intense Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	6287bc3e-8b05-45d3-e053-2991aa0aaa10	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Multi-Protection Refreshing Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	8867d791-7e93-4f39-aaaf-bfbee8296fd9	2026-01-08	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Cream	BENZOCAINE	HEB	a71c5259-cbcf-7566-e053-2995a90a2cb6	2026-01-08	Warnings	Exact identifier application number: M022
Topco Associates LLC Maximum Strength	FLUORIDE	Topco Associates LLC	387d264c-90cc-5e67-e063-6394a90a713d	2026-01-08	Warnings	Exact identifier application number: M022
TopCare Sensitive Extra Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	TOPCO Assoc. LLC	835f41cf-e920-7df7-e053-2a91aa0a4479	2026-01-08	Warnings	Exact identifier application number: M022 ndc (product): 36800-451
Scope Icy Blast	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	164ed151-01d3-021a-e063-6294a90a0e51	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Advanced Enamel Care	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	1660e7d7-5b8d-8aba-e063-6294a90a50d8	2026-01-08	Warnings	Exact identifier application number: M022
Crest Deep Cleanse Germ Treatment	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	2d6b15d4-7827-ec2f-e063-6294a90a82c8	2026-01-08	Warnings	Exact identifier application number: M022
Crest Scope Original	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	21eed451-9368-146c-e063-6294a90af62b	2026-01-08	Warnings	Exact identifier application number: M022
3x Medicated Mouth Sore Gel	BENZOCAINE	HEB	a71c5259-cbd1-7566-e053-2995a90a2cb6	2026-01-08	Warnings	Exact identifier application number: M022
HEB Extra Whitening	FLUORIDE	HEB	b76c3591-6383-4661-b3db-7a56b11202f7	2026-01-08	Warnings	Exact identifier application number: M022

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	835f41cf-e920-7df7-e053-2a91aa0a4479	14
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	835f41cf-e920-7df7-e053-2a91aa0a4479	14
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	835f41cf-e920-7df7-e053-2a91aa0a4479	14
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	835f41cf-e920-7df7-e053-2a91aa0a4479	14
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	835f41cf-e920-7df7-e053-2a91aa0a4479	14
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	835f41cf-e920-7df7-e053-2a91aa0a4479	14
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	835f41cf-e920-7df7-e053-2a91aa0a4479	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-451-59	36800045159	1 TUBE in 1 CARTON (36800-451-59) / 113 g in 1 TUBE	1 tube	2011-01-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5820185 TopCare Max Str Sensitive Extra Whitening	TOPCO Assoc. LLC \| Lornamead Products	2026-01-08	HUMAN OTC DRUG LABEL	14