BIO SPECTRA

Product NDC
61649-723
11-digit product format
616490723
Labeler code
61649
Product ID
61649-723_26aa66ba-92de-e15f-e063-6394a90a35c3
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
9055-7588 Qu�bec Inc. DBA Attitude
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-15
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
61649-723-01BIO SPECTRAATTITUDE120 g in 1 TUBEGEL, DENTIFRICE1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61649-723BIO SPECTRA ATTITUDE (SODIUM FLUORIDE) GEL, DENTIFRICE [9055-7588 QUÉBEC INC. DBA ATTITUDE]6Current NDC, Legacy NDC, 1 package rows20241114_54bd43c9-489d-4e6b-9031-90ec0e3c4516.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN54bd43c9-489d-4e6b-9031-90ec0e3c45166
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD54bd43c9-489d-4e6b-9031-90ec0e3c45166
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY54bd43c9-489d-4e6b-9031-90ec0e3c45166
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY54bd43c9-489d-4e6b-9031-90ec0e3c45166
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY54bd43c9-489d-4e6b-9031-90ec0e3c45166
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY54bd43c9-489d-4e6b-9031-90ec0e3c45166

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61649-723-0161649072301120 g in 1 TUBE (61649-723-01) 120 g2021-05-150000-00-00NoNoCurrent