Home NDC 87846-007 Freshen Up
Product NDC 87846-007
11-digit product format 878460007
Labeler code 87846
Product ID 87846-007_56acecd2-6967-2ee4-e063-6394a90a356f
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler DABUR INDIA LIMITED
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-10
Substance SODIUM FLUORIDE
Active strength 24 mg/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 Freshen Up
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 24 mg/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 416783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87846-007-13 87846000713 113 g in 1 BOTTLE (87846-007-13) 113 g 2025-02-10 No No Current 87846-007-14 87846000714 141 g in 1 BOTTLE (87846-007-14) 141 g 2025-02-10 No No Current