Home NDC 77782-002 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 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 Freshen Up
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 5 g/100g SODIUM FLUORIDE 24 mg/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup 8ZYQ1474W7 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 77782-002-13 Freshen Up 113 g in 1 BOTTLE GEL, DENTIFRICE 113 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77782-002 FRESHEN UP (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [MKJ BRANDS LLC] 1 Current NDC, 1 package rows 20250226_2ee626d1-6150-87db-e063-6294a90a64d8.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 6 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 77782-002-13 77782000213 113 g in 1 BOTTLE (77782-002-13) 113 g 2025-02-10 No No Current