Home NDC 83610-1060 OraPro Fluoride Anticavity
Product NDC 83610-1060
11-digit product format 836101060
Labeler code 83610
Product ID 83610-1060_3995ff67-0795-cc1d-e063-6394a90af7ff
Type HUMAN OTC DRUG
Nonproprietary name Fluoride Toothpaste
Dosage form PASTE, DENTIFRICE
Route ORAL
Labeler Protegera, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-30
Substance SODIUM FLUORIDE
Active strength 1.4 mg/g
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 OraPro Fluoride Anticavity
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.4 mg/g
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83610-1060-1 OraPro Fluoride Anticavity 1 in 1 CARTON PASTE, DENTIFRICE 1 4 83610-1060-1 OraPro Fluoride Anticavity 147 g in 1 TUBE PASTE, DENTIFRICE 147 4
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 5 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 83610-1060-1 83610106001 1 TUBE in 1 CARTON (83610-1060-1) / 147 g in 1 TUBE 1 tube 2025-06-30 No No Current