Home NDC 53567-0033 Supersmile
Product NDC 53567-0033
11-digit product format 535670033
Labeler code 53567
Product ID 53567-0033_47e56e2b-2fa1-1886-e063-6394a90af31f
Type HUMAN OTC DRUG
Nonproprietary name Sodium Monofluorophosphate
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Robell Research, Inc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-15
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength .14 g/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 Supersmile
Brand name suffix Professional whitening TP Original Mint
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE .14 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2695772 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 53567-0033-1 SupersmileProfessional whitening TP Original Mint 40 g in 1 TUBE PASTE, DENTIFRICE 40 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53567-0033 SUPERSMILE PROFESSIONAL WHITENING TP ORIGINAL MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC] 2 Current NDC, 1 package rows 20250119_2502c305-71ab-bb71-e063-6394a90a0a84.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 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 53567-0033-1 53567003301 40 g in 1 TUBE (53567-0033-1) 40 g 2024-10-15 No No Current