Home NDC 51206-312 Opal by Opalescence Original
Product NDC 51206-312
11-digit product format 512060312
Labeler code 51206
Product ID 51206-312_5b14e96f-d015-5738-e063-6294a90ac014
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Ultradent Products, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-19
Marketing end 2029-02-21
Substance SODIUM FLUORIDE
Active strength 1.1 mg/g
NDC exclude flag No
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 Opal by Opalescence Original Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 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 1044547 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51206-312-01 Opal by Opalescence Original 1 in 1 CARTON GEL, DENTIFRICE 1 5 51206-312-01 Opal by Opalescence Original 133 g in 1 TUBE GEL, DENTIFRICE 133 5 51206-312-02 Opal by Opalescence Original 1 in 1 CARTON GEL, DENTIFRICE 1 5 51206-312-02 Opal by Opalescence Original 3 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51206-312 OPAL BY OPALESCENCE ORIGINAL (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 4 Current NDC, 4 package rows 20250402_5c3bf8fc-2e8f-4a58-bcbf-e47540072a49.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 40 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 Marketing end Sample Exclude flag Status 51206-312-01 51206031201 1 TUBE in 1 CARTON (51206-312-01) / 133 g in 1 TUBE 1 tube 2023-11-19 2029-02-21 No No Historical 51206-312-02 51206031202 3 CARTON in 1 PACKAGE, COMBINATION (51206-312-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 3 carton 2023-11-19 2029-02-21 No No Historical