BIO SPECTRA

Product NDC
61649-732
11-digit product format
616490732
Labeler code
61649
Product ID
61649-732_2b9876fb-e9e1-4dbc-e063-6294a90a8696
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
2024-01-01
Substance
SODIUM FLUORIDE
Active strength
.243 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
IngredientStrength
SODIUM FLUORIDE.243 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui891775

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61649-732-01BIO SPECTRAATTITUDE120 g in 1 TUBEGEL, DENTIFRICE1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61649-732BIO SPECTRA ATTITUDE (SODIUM FLUORIDE) GEL, DENTIFRICE [9055-7588 QUEBEC INC. DBA ATTITUDE]5Current NDC, Legacy NDC, 1 package rows20250115_d33e3778-ba1d-4560-bafa-74f7ab88c6b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNd33e3778-ba1d-4560-bafa-74f7ab88c6b55
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDd33e3778-ba1d-4560-bafa-74f7ab88c6b55
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYd33e3778-ba1d-4560-bafa-74f7ab88c6b55
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYd33e3778-ba1d-4560-bafa-74f7ab88c6b55
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYd33e3778-ba1d-4560-bafa-74f7ab88c6b55
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYd33e3778-ba1d-4560-bafa-74f7ab88c6b55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61649-732-0161649073201120 g in 1 TUBE (61649-732-01) 120 g2024-01-010000-00-00NoNoCurrent