Home NDC 51206-313 Opal by Opalescence Complete
Product NDC 51206-313
11-digit product format 512060313
Labeler code 51206
Product ID 51206-313_5b14f120-efa2-668b-e063-6294a90ab0fc
Type HUMAN OTC DRUG
Nonproprietary name Opal by Opalescence Complete
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Ultradent Products, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-21
Marketing end 2027-08-14
Substance STANNOUS 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 Complete Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS 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 3FTR44B32Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416784 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 51206-313-01 Opal by Opalescence Complete 1 in 1 CARTON GEL, DENTIFRICE 1 3 51206-313-01 Opal by Opalescence Complete 133 g in 1 TUBE GEL, DENTIFRICE 133 3 51206-313-02 Opal by Opalescence Complete 1 in 1 CARTON GEL, DENTIFRICE 1 3 51206-313-02 Opal by Opalescence Complete 12 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51206-313 OPAL BY OPALESCENCE COMPLETE GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 2 Current NDC, 4 package rows 20241208_249cc46a-dad6-0345-e063-6394a90a4447.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 35 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 51206-313-01 51206031301 1 TUBE in 1 CARTON (51206-313-01) / 133 g in 1 TUBE 1 tube 2024-10-21 2027-08-14 No No Historical 51206-313-02 51206031302 12 CARTON in 1 PACKAGE, COMBINATION (51206-313-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 12 carton 2024-10-21 2027-08-14 No No Historical