FDA.reportPublic FDA data

Freshmint Sensitive

Product NDC
51824-053
Requested package NDC
51824-053-02
11-digit product format
518240053
Labeler code
51824
Product ID
51824-053_5ce0e2fd-1e21-2114-e063-6394a90ac022
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate and Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
New World Imports, Inc
Application
m021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-09-16
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
2.4; 50 mg/g; mg/g
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
Freshmint Sensitive
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.4 mg/g
POTASSIUM NITRATE50 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-053-01Freshmint Sensitive122 g in 1 TUBEPASTE, DENTIFRICE1226
51824-053-02Freshmint Sensitive1 in 1 BOXPASTE, DENTIFRICE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-053FRESHMINT SENSITIVE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]5Current NDC, Legacy NDC, 2 package rows20250331_aa2e0864-3325-4acf-a2c5-0eb27eb18baf.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshmint SensitivePOTASSIUM NITRATE AND SODIUM FLUORIDENew World Imports, Incaa2e0864-3325-4acf-a2c5-0eb27eb18baf2025-12-01WarningsExact identifier
ndc (package): 51824-053-02
ndc (product): 51824-053
ndc11 (package): 51824005302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNaa2e0864-3325-4acf-a2c5-0eb27eb18baf6
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDaa2e0864-3325-4acf-a2c5-0eb27eb18baf6
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYaa2e0864-3325-4acf-a2c5-0eb27eb18baf6
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYaa2e0864-3325-4acf-a2c5-0eb27eb18baf6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYaa2e0864-3325-4acf-a2c5-0eb27eb18baf6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYaa2e0864-3325-4acf-a2c5-0eb27eb18baf6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYaa2e0864-3325-4acf-a2c5-0eb27eb18baf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-053-02518240053021 TUBE in 1 BOX (51824-053-02) / 122 g in 1 TUBE (51824-053-01) 1 tube2010-09-160000-00-00NoNoCurrent