FDA.reportPublic FDA data

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
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
ac398ff0-0010-4e13-8b89-dc986fd7f974Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-481-492024-02-23C16284748780-1f386c649-ac5d-0266-e053-dadaa90a7c1a5820184 Topco Max Str Sens Mint
36800-481-492023-01-30C16284748780-1f386c649-ac5d-0266-e053-dadaa90a7c1a5820184 Topco Max Str Sens Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-481-42Topco Associates LLCMaximum Strength113 g in 1 TUBEPASTE, DENTIFRICE1139
36800-481-49Topco Associates LLCMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
NITRATE IONACTIVE MOIETYT93E9Y2844TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-481TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 2 package rows20250119_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 20 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Mouth Sore ReliefBENZOCAINEWalgreens253d7ea2-e48e-c7d7-e063-6394a90ae0012025-08-12WarningsExact identifier
application number: M022
Charm Tex FLUORIDE GelSODIUM FLUORIDEYangzhou Hongshengding Chemical Co.,Ltd.897b0102-1c96-4699-908e-a7b7e26cd29f2025-08-08WarningsExact identifier
application number: M022
Meijer Enamel GuardPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer Distribution Inc82bc95be-0a07-3f00-e053-2a91aa0a74382025-08-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLCac398ff0-0010-4e13-8b89-dc986fd7f9742025-08-08WarningsExact identifier
application number: M022
ndc (product): 36800-481
QUALITY CHOICE SALINEPLUS SOOTHING ALOEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)4ae4e88a-aaa5-4195-bedc-622fd5cd93942025-07-30WarningsExact identifier
application number: M022
Aseptil RojoPHENOLMenper Distributors, Inc.62c96dc1-4698-43c1-8e6d-f4062dc5eea22025-07-22WarningsExact identifier
application number: M022
AnestenkaBENZOCAINEMenper Distributors, Inc00a3f1bc-ddfe-47c6-8221-f48f915135032025-07-22WarningsExact identifier
application number: M022
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
application number: M022
SprinJene Natural Sensitivity and GumPOTASSIUM NITRATEHealth and Natural Beauty USA Corp3cb23e36-0e8c-4172-b4ae-859b58a2739f2025-07-07WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Berry TwistSODIUM FLUORIDEHaleon US Holdings LLC69c07c36-b5e0-420b-ab29-7d10913863222025-07-03WarningsExact identifier
application number: M022
DenTek Instant Pain Relief Maximum StrengthBENZOCAINEDenTek Oral Care, Inc.ae92b76e-815a-4b4c-8128-bd045098caa52025-06-30WarningsExact identifier
application number: M022
Sensodyne Clinical White Stain ProtectorPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC99037e59-53d6-492c-8fce-67641fc8efdd2025-06-25WarningsExact identifier
application number: M022
Iolite-SBENZOCAINEDharma Research, Inc.b3b68914-2adc-4f07-9521-0b18756be5222025-06-14WarningsExact identifier
application number: M022
Red Cross ToothacheEUGENOLThe Mentholatum Company3537e599-65d9-48d6-8a46-d42312f71e842025-06-11WarningsExact identifier
application number: M022
QUALITY CHOICE Sore ThroatPHENOLCHAIN DRUG MARKETING ASSOCIATIONc95ee086-f384-475d-ad0c-75518cb9d2fe2025-06-10WarningsExact identifier
application number: M022
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier
application number: M022
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC9e1f7462-a052-4db4-bc59-cce437b695d02025-05-20WarningsExact identifier
application number: M022
Saline 1.5 FL OZSALINEALAINA HEALTHCARE PRIVATE LIMITEDf1bdbb25-6943-4828-9ae0-7d9783c18b5f2025-05-19WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYac398ff0-0010-4e13-8b89-dc986fd7f9749

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-481-4236800048142113 g in 1 TUBE113 gHistorical
36800-481-49368000481491 TUBE in 1 CARTON (36800-481-49) / 113 g in 1 TUBE (36800-481-42) 1 tube2012-11-152028-06-26NoNoCurrent