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 2 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	Warnings	Exact identifier application number: M022
Ludens Watermelon Throat Drops	PECTIN	Prestige Brands Holdings, Inc.	adfb248a-96bb-4742-9df6-c47edccdd671	2026-08-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	584b38ce-d1ef-4ecc-a887-7c96e7f9669f	2026-08-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Walgreens	fb93c7f6-e025-4cf2-9997-acfe9a0debdd	2026-08-19	Warnings	Exact identifier application number: M022
CVS Saline	NASAL	CVS PHARMACY	f02c41b0-c78e-41cd-aa4a-2756bbe92087	2026-08-19	Warnings	Exact identifier application number: M022
Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	5965eb2a-1261-5258-e063-6294a90a7c2d	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Honey Licorice Throat Drops	MENTHOL	Prestige Brands Holdings, Inc.	5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Dual Relief	PECTIN AND MENTHOL	Prestige Brands Holdings, Inc.	d0213cb3-ec8e-40cc-82c9-694032f0490f	2026-08-19	Warnings	Exact identifier application number: M022
CVS Health Sore Throat Fast Relief Oral Anesthetic	PHENOL	CVS Pharmacy,Inc.	4fb880db-2185-41ef-a5f9-8983a28d2c5b	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Cherry	PHENOL	CVS Pharmacy,Inc.	887c68e0-ff44-4bad-b360-56fb99ed9c45	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Menthol Flavor	PHENOL	CVS PHARMACY,INC.	665be058-b965-4b78-80b0-dd8524180932	2026-08-17	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Harris Teeter, LLC	7e5f175d-f0d6-4665-ac14-1873d6b99c80	2026-08-12	Warnings	Exact identifier application number: M022
Gingicaine Gel Variety Pak	GINGICAINE GEL VARIETY PAK	Gingi-Pak a Division of the Belport	62ed4ff3-18f6-5c67-e053-2991aa0a7792	2026-08-11	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent ReadyInCase	HYDROGEN PEROXIDE	P & L Development, LLC	b0866db5-3b0d-4478-9b3b-1f077d2f5393	2026-08-06	Warnings	Exact identifier application number: M022
Ollie Fresh Mint	SODIUM FLUORIDE, POTASSIUM NITRATE	Brio Product Group LLC.	ebeec44f-3c22-43f2-9256-6ece6025c105	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	5868c5a1-273f-f023-e063-6394a90ac9d8	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58690bb5-9604-26a4-e063-6394a90afdbe	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586918cf-7b13-5999-e063-6294a90a88a9	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586924a0-322d-5dc3-e063-6294a90a1556	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58692e90-de74-52d3-e063-6394a90a9702	2026-08-06	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