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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SENSODYNE Rapid Relief	STANNOUS FLUORIDE	Haleon US Holdings LLC	f9589e7c-c5ca-4465-8d37-47ad6c69249f	2024-03-06	Warnings	Exact identifier application number: M022
SENSODYNE Repair and Protect Extra Fresh	STANNOUS FLUORIDE	Haleon US Holdings LLC	34260c69-d829-46c0-b12a-5136ee073ba1	2024-03-06	Warnings	Exact identifier application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTH	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	76adbccb-0812-4407-a6fc-a57e6f144fbb	2024-03-05	Warnings	Exact identifier application number: M022
SENSODYNE Advanced Whitening	POTASSIUM NITRATE	Haleon US Holdings LLC	a06e2549-3c4e-4818-b53e-1dea6828219f	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Extra Whitening Cool Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	c977f2c4-e0f3-44d2-aa7a-845f0583af3e	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Natural white	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	911ac7e4-2b92-43d5-af0b-b5f741b088fb	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Nourish Healthy White	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	aca38560-2fd7-47be-9e93-2abc3214e856	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Nourish Gently Soothing	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	5403ab67-532c-4bdf-9b06-07b1866f37f1	2024-03-04	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Active Shield Fresh Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	e8684615-f544-4871-b935-0a0f93639d7d	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Fresh Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	3dfa6827-3aae-4f19-93f6-2ded2faf2ddd	2024-03-04	Warnings	Exact identifier application number: M022
Made by Dentists Sensitive and Whitening Fresh Mint	POTASSIUM NITRATE, SODIUM FLUORIDE	MADE BY DENTISTS INC	0d379c26-69ff-4666-9ad5-7618f0bd139f	2024-02-27	Warnings	Exact identifier application number: M022
Polident ProPartial	STANNOUS FLUORIDE	Haleon US Holdings LLC	557eeb32-64f4-41e8-ada4-91bd39ae2920	2024-02-07	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Daily Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	edffce4d-108b-4ffd-9adf-e12cb42ffddd	2024-01-24	Warnings	Exact identifier application number: M022
Peppermint Twist	FLUORIDE	Caldwell Health LLC	4b28cdd1-0dba-42f5-a9e8-06d9e75b2396	2024-01-17	Warnings	Exact identifier application number: M022
The Natural Dentist Groovy Grape	FLUORIDE	Caldwell Consumer Health LLC	087abbed-1f58-4b45-a76b-a950fa81c18c	2024-01-16	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	Pharma Nobis, LLC	e42fccc2-1b4f-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M022
Sunmark Benzoin Compound Tincture	BENZOIN RESIN	Strategic Sourcing Services LLC	0c96d810-83dc-47d3-9a75-63a79feaad0a	2023-12-19	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	Humco Holding Group, Inc.	b33b5896-673b-498c-8a58-76ece8552f7a	2023-12-15	Warnings	Exact identifier application number: M022
Povidone Iodine	POVIDONE IODINE ORAL RINSE 0.5%	Humco Holding Group, Inc.	b83dbdd1-ff63-caf8-e053-2a95a90a5764	2023-12-15	Warnings	Exact identifier application number: M022
Moon Whitening Gel Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0c556a29-a697-3a66-e063-6394a90abfee	2023-12-12	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