FDA.reportPublic FDA data

Topco Associates LLC

Product NDC
36800-364
11-digit product format
368000364
Labeler code
36800
Product ID
36800-364_47e514c6-af35-cdd8-e063-6394a90aea44
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
2025-06-26
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
Topco Associates LLC
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.15 g/100g
POTASSIUM NITRATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
387d264c-90cc-5e67-e063-6394a90a713dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-364-10Topco Associates LLCMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE13
36800-364-10Topco Associates LLCMaximum Strength113 g in 1 TUBEPASTE, DENTIFRICE1133

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 30 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental72fd2232-cd5a-4e25-b139-522b589c44722025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC42521b29-67e4-4a16-848d-7e6ba4a7ece22025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC723da3ae-3f1f-4962-920b-f2a30c8c32532025-01-08Warnings, Adverse reactionsExact identifier
application number: M022
V34 Colour CorrectorV34 COLOUR CORRECTORJiangxi Dentalbright Technology Co., Ltd2b2a0b47-7628-4b85-e063-6294a90a45a02025-01-07WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.bc2e7ac3-f9e4-49cc-9f0c-6fe94479314d2025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.fb38b10d-0faf-403c-9921-d4f6b0f6aa552025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.a9dc2245-c029-4453-bfc5-8fb899873c342025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.ba49a18d-8568-421b-a495-8fee863c97572025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.c9b584d9-7407-445a-b084-926250af9f8e2025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.4aa6eec8-394a-4ecb-8173-66561fd649132025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.25c99ae3-90f4-4a63-924d-f810b3ba6e602025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.84e8d5c8-2a35-4179-9a9c-9a4a52c2cae62025-01-03WarningsExact identifier
application number: M022
Prevention Oncology Mouth RinseGLYCERINPrevention Health Sciences, Inc.1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c2025-01-01WarningsExact identifier
application number: M022
Prevention Mouth Sore RinseHYDROGEN PEROXIDEPrevention Health Sciences, Inc.2eae61e4-1800-5fa6-e063-6394a90a95832025-01-01WarningsExact identifier
application number: M022
Antiseptic Lil Drug Store ProductsEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLLil' Drug Store Products, Incdca36a30-2c9f-4d0b-be88-b45c7046f5092024-12-31WarningsExact identifier
application number: M022
Sensodyne Clinical White Intensive CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCf193ec40-032f-42c7-81f1-029ec89893742024-12-31WarningsExact identifier
application number: M022
TeethWhitening KitTEETHWHITENING KITJiangxi Dentalbright Technology Co., Ltd.29393313-217a-dc3a-e063-6294a90addb12024-12-20WarningsExact identifier
application number: M022
Breezers Cool BerryPECTINMondelez Global LLCb31d0078-21d7-4d18-a8d3-7c8d48d6d0042024-12-20WarningsExact identifier
application number: M022
Breezers Creamy StrawberryPECTINMondelez Global LLC777fd6db-f129-4489-8312-4b1aca94878e2024-12-20WarningsExact identifier
application number: M022
Halls Breezers Sugar Free Cool BerryPECTINMondelez Global LLCdd1b4b17-4f73-4052-9589-d5fd6bb059bb2024-12-20WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN387d264c-90cc-5e67-e063-6394a90a713d3
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD387d264c-90cc-5e67-e063-6394a90a713d3
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY387d264c-90cc-5e67-e063-6394a90a713d3
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY387d264c-90cc-5e67-e063-6394a90a713d3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY387d264c-90cc-5e67-e063-6394a90a713d3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY387d264c-90cc-5e67-e063-6394a90a713d3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY387d264c-90cc-5e67-e063-6394a90a713d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
36800-364-10368000364101 TUBE in 1 CARTON (36800-364-10) / 113 g in 1 TUBE1 tube2025-06-26NoNoCurrent