FDA.reportPublic FDA data

Freshen Up

Product NDC
77782-002
11-digit product format
777820002
Labeler code
77782
Product ID
77782-002_3763947b-98bb-c1f3-e063-6394a90a89ab
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE, POTASSIUM NITRATE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
MKJ BRANDS LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-10
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; 24 g/100g; mg/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC2ee626d1-6150-87db-e063-6294a90a64d82025-06-12WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Stop use and ask a dentist if the problem persists or worsens, snesitive teeth may indicate a serious problem that may need prompt care by dentist. Pain senstivity still persists after 4 weeks of use Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Freshen Up
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE24 mg/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77782-002-13Freshen Up113 g in 1 BOTTLEGEL, DENTIFRICE1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77782-002FRESHEN UP (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [MKJ BRANDS LLC]1Current NDC, 1 package rows20250226_2ee626d1-6150-87db-e063-6294a90a64d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN2ee626d1-6150-87db-e063-6294a90a64d82
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD2ee626d1-6150-87db-e063-6294a90a64d82
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2ee626d1-6150-87db-e063-6294a90a64d82
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2ee626d1-6150-87db-e063-6294a90a64d82
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2ee626d1-6150-87db-e063-6294a90a64d82
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2ee626d1-6150-87db-e063-6294a90a64d82
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY2ee626d1-6150-87db-e063-6294a90a64d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
77782-002-1377782000213113 g in 1 BOTTLE (77782-002-13) 113 g2025-02-10NoNoCurrent