Home NDC 61649-733 BIO SPECTRA
Product NDC 61649-733
11-digit product format 616490733
Labeler code 61649
Product ID 61649-733_124a286a-fd2a-6d1d-e063-6294a90a6c18
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride and Potassium nitrate
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler 9055-7588 Quebec Inc. DBA Attitude
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-26
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength .243; 5 g/100g; g/100g
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 BIO SPECTRA
Brand name suffix ATTITUDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .243 g/100g POTASSIUM NITRATE 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038800 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 61649-733-01 BIO SPECTRAATTITUDE 120 g in 1 TUBE PASTE, DENTIFRICE 120 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61649-733 BIO SPECTRA ATTITUDE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [9055-7588 QUEBEC INC. DBA ATTITUDE] 5 Current NDC, Legacy NDC, 1 package rows 20240426_42b79ec5-f37f-4dc9-9631-c8b1c153fe88.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 15 of 40 · 786 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 61649-733-01 61649073301 120 g in 1 TUBE (61649-733-01) 120 g 2024-04-26 0000-00-00 No No Current