Home NDC 61649-730 BIO SPECTRA
Product NDC 61649-730
11-digit product format 616490730
Labeler code 61649
Product ID 61649-730_124a0f25-69f9-4a20-e063-6294a90a1009
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler 9055-7588 Quebec Inc. DBA Attitude
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-01
Substance SODIUM FLUORIDE
Active strength .243 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
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 891775 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61649-730-01 BIO SPECTRAATTITUDE 120 g in 1 TUBE GEL, DENTIFRICE 120 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61649-730 BIO SPECTRA ATTITUDE (SODIUM FLUORIDE) GEL, DENTIFRICE [9055-7588 QUEBEC INC. DBA ATTITUDE] 4 Current NDC, Legacy NDC, 1 package rows 20240301_e3bb60f8-2a06-42d6-a182-8c31bb982a2a.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 45 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 61649-730-01 61649073001 120 g in 1 TUBE (61649-730-01) 120 g 2024-03-01 0000-00-00 No No Current