Topco Associates LLC

Product NDC: 36800-481
11-digit product format: 368000481
Labeler code: 36800
Product ID: 36800-481_3bdd8cfe-1ef8-35cd-e063-6394a90a3165
Type: HUMAN OTC DRUG
Nonproprietary name: Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Topco Associates LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-01-20
Marketing end: 2028-06-26
Substance: SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength: .15; 5 g/100g; g/100g
NDC exclude flag: No
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: Topco Associates LLC
Brand name suffix: Maximum Strength

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
ac398ff0-0010-4e13-8b89-dc986fd7f974	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-481-49	2024-02-23	C162847	48780-1	f386c649-ac5d-0266-e053-dadaa90a7c1a	5820184 Topco Max Str Sens Mint
36800-481-49	2023-01-30	C162847	48780-1	f386c649-ac5d-0266-e053-dadaa90a7c1a	5820184 Topco Max Str Sens Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-481-42	Topco Associates LLCMaximum Strength	113 g in 1 TUBE	PASTE, DENTIFRICE	113		9
36800-481-49	Topco Associates LLCMaximum Strength	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	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
NITRATE ION	ACTIVE MOIETY	T93E9Y2844	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
SODIUM PHOSPHATE, TRIBASIC	INACTIVE INGREDIENT	A752Q30A6X	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-481	TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250119_ac398ff0-0010-4e13-8b89-dc986fd7f974.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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Gum Therapy Glacier Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ed6889b6-58db-41cf-e053-2a95a90a7de2	2024-11-11	Warnings	Exact identifier application number: M022
Listerine FreshBurst Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	dd3729c2-fd05-4db0-a542-487bb0f9001f	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	9e97e4f8-80c2-44e0-862c-0dfca392a436	2024-11-11	Warnings	Exact identifier application number: M022
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier application number: M022
BIOTENE Fresh Mint Original	SODIUM FLUORIDE	Haleon US Holdings LLC	1101c17f-c848-4cd5-a7cd-679b59dbe1bf	2024-11-05	Warnings	Exact identifier application number: M022
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Cherry	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	a0e145c8-6b08-40be-ae4f-5678c4a78b1e	2024-10-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33b-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Mint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	be57ca56-834f-4170-a407-f193484d8b0a	2024-10-29	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	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	ac398ff0-0010-4e13-8b89-dc986fd7f974	9
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	ac398ff0-0010-4e13-8b89-dc986fd7f974	9
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	ac398ff0-0010-4e13-8b89-dc986fd7f974	9
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	ac398ff0-0010-4e13-8b89-dc986fd7f974	9
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	ac398ff0-0010-4e13-8b89-dc986fd7f974	9
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	ac398ff0-0010-4e13-8b89-dc986fd7f974	9
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	ac398ff0-0010-4e13-8b89-dc986fd7f974	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-481-42	36800048142	113 g in 1 TUBE	113 g					Historical
36800-481-49	36800048149	1 TUBE in 1 CARTON (36800-481-49) / 113 g in 1 TUBE (36800-481-42)	1 tube	2012-11-15	2028-06-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5820184 Topco Max Str Sens Mint	Topco Associates LLC \| Lornamead Products \| Lornamead	2025-08-08	HUMAN OTC DRUG LABEL	9