BIO SPECTRA

Product NDC
61649-725
11-digit product format
616490725
Labeler code
61649
Product ID
61649-725_4198c066-4cac-ccb5-e063-6294a90ac5a5
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
2024-02-05
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
61649-725-01BIO SPECTRAATTITUDE120 g in 1 TUBEGEL, DENTIFRICE1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61649-725BIO SPECTRA ATTITUDE (SODIUM FLUORIDE) GEL, DENTIFRICE [9055-7588 QUEBEC INC. DBA ATTITUDE]5Current NDC, Legacy NDC, 1 package rows20241114_7d04d050-b283-4fce-b1e9-e695b70363f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN7d04d050-b283-4fce-b1e9-e695b70363f96
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD7d04d050-b283-4fce-b1e9-e695b70363f96
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY7d04d050-b283-4fce-b1e9-e695b70363f96
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY7d04d050-b283-4fce-b1e9-e695b70363f96
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY7d04d050-b283-4fce-b1e9-e695b70363f96
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY7d04d050-b283-4fce-b1e9-e695b70363f96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61649-725-0161649072501120 g in 1 TUBE (61649-725-01) 120 g2024-02-050000-00-00NoNoCurrent