Top Care

Product NDC: 36800-681
11-digit product format: 368000681
Labeler code: 36800
Product ID: 36800-681_4395839a-f420-fe45-e063-6394a90a33d3
Type: HUMAN OTC DRUG
Nonproprietary name: 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: 2026-12-31
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: Top Care
Brand name suffix: Enamel Guard
Listing expiration: 2026-12-31

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
8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-681-19	Top CareEnamel Guard	113 g in 1 TUBE	PASTE, DENTIFRICE	113		9
36800-681-19	Top CareEnamel Guard	1 in 1 CARTON	PASTE, DENTIFRICE	1		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POTASSIUM NITRATE	ACTIVE INGREDIENT	RU45X2JN0Z	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
NITRATE ION	ACTIVE MOIETY	T93E9Y2844	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
SODIUM METHYL COCOYL TAURATE	INACTIVE INGREDIENT	JVL98CG53G	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-681	TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250119_8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c.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 9 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Wintergreen Peppermint	POTASSIUM NITRATE, SODIUM FLUORIDE	Twice Twice LLC	7b7beec2-e070-4102-a2a4-68c332fc9fb3	2026-01-19	Warnings	Exact identifier application number: M022
GuruNanda Sensitive	POTASSIUM NITRATE	GURUNANDA, LLC	3ef0d3d4-fd42-0181-e063-6394a90af09c	2026-01-19	Warnings	Exact identifier application number: M022
Up and Up Antiseptic	CETYLPYRIDINIUM CHLORIDE	Target Corporation	386ee9f9-598e-ad00-e063-6394a90aeb46	2026-01-19	Warnings	Exact identifier application number: M022
Colgate Sensitive Complete Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	4a8f1d2f-b326-46d2-8914-d65ccc409edf	2026-01-18	Warnings	Exact identifier application number: M022
Colgate Sensitive Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	3b656928-af58-4ee9-8fb8-360688eb9bf3	2026-01-13	Warnings	Exact identifier application number: M022
Colgate Sensitive Enamel Health	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	a50d4259-8a79-417e-b381-72c7a8ec0418	2026-01-13	Warnings	Exact identifier application number: M022
Walgreens Sensitive Enamel Repair	SODIUM FLUORIDE	Walgreens	41d6384d-695b-b60b-e063-6394a90aa0b9	2026-01-09	Warnings	Exact identifier application number: M022
HyVee Throat Drops Lemon Mint	MENTHOL	HY-VEE, INC	47f738cc-7968-cc07-e063-6294a90af7ab	2026-01-09	Warnings	Exact identifier application number: M022
CVS Health Clinical White Stain Protector	SODIUM FLUORIDE	CVS Pharmacy	41d5c3a9-abe5-5528-e063-6294a90ada79	2026-01-09	Warnings	Exact identifier application number: M022
CVS Health Sensitive Enamel Repair	SODIUM FLUORIDE	CVS	41d547b3-2feb-8e83-e063-6294a90ae3cd	2026-01-09	Warnings	Exact identifier application number: M022
Moon Platinum Advanced Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care LLC	ded3a5a6-2883-f3de-e053-2a95a90afb94	2026-01-09	Warnings	Exact identifier application number: M022
Moon Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0bdcad3e-b8e9-bd91-e063-6394a90a666a	2026-01-09	Warnings	Exact identifier application number: M022
Colgate Sensitive Prevent and Repair	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	e67410dc-a671-4611-8af1-097be071cd1c	2026-01-09	Warnings	Exact identifier application number: M022
Colgate Sensitive plus Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	2092c747-e025-47a9-9e54-731631d3c831	2026-01-09	Warnings	Exact identifier application number: M022
Dentemp Canker Cover	CANKER COVER	DOC Brands	2e7fbf9d-553c-c7bf-e063-6294a90a5f79	2026-01-08	Warnings	Exact identifier application number: M022
HyVee Throat Drops Lemon Mint	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	47e2650f-4f50-8d85-e063-6394a90a1ddc	2026-01-08	Warnings	Exact identifier application number: M022
Dentemp Canker Cover	CANKER COVER	DOC Brands	2b4b22e9-a03b-fb8f-e063-6394a90a8747	2026-01-08	Warnings	Exact identifier application number: M022
Crest 3D White Advanced	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	f3aa9a59-b4d4-05d9-e053-2995a90a0aea	2026-01-08		Exact identifier application number: M022
Oral B Plaque Defense Special Care Oral Rinse	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d503fad5-a378-0e60-e053-2a95a90abe65	2026-01-08	Warnings	Exact identifier application number: M022
Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All Day	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d5f69341-b659-c74a-e053-2a95a90a317e	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	8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c	9
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c	9
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c	9
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c	9
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c	9
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c	9
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-681-19	36800068119	1 TUBE in 1 CARTON (36800-681-19) / 113 g in 1 TUBE	1 tube	2012-11-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5820186 Topco Enamel Guard	TOPCO Assoc. LLC \| Lornamead Products	2025-11-14	HUMAN OTC DRUG LABEL	9