FDA.reportPublic FDA data

Farmasi Whitening

Product NDC
74690-012
11-digit product format
746900012
Labeler code
74690
Product ID
74690-012_09734a55-efb4-3b22-e063-6394a90ad2d2
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Farmasi US LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-15
Substance
SODIUM FLUORIDE
Active strength
1.5 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Farmasi Whitening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74690-012-01Farmasi Whitening1 in 1 BOXPASTE, DENTIFRICE13
74690-012-01Farmasi Whitening112 g in 1 TUBEPASTE, DENTIFRICE1123
74690-012-02Farmasi Whitening25 g in 1 TUBEPASTE, DENTIFRICE253
74690-012-02Farmasi Whitening1 in 1 BOXPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74690-012FARMASI WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [FARMASI US LLC]3Current NDC, Legacy NDC, 4 package rows20231106_25b3608e-abed-41ca-9971-21981b8a4610.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN25b3608e-abed-41ca-9971-21981b8a46103
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD25b3608e-abed-41ca-9971-21981b8a46103
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY25b3608e-abed-41ca-9971-21981b8a46103
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY25b3608e-abed-41ca-9971-21981b8a46103
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY25b3608e-abed-41ca-9971-21981b8a46103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
74690-012-01746900012011 TUBE in 1 BOX (74690-012-01) / 112 g in 1 TUBE1 tube2021-04-150000-00-00NoNoCurrent
74690-012-02746900012021 TUBE in 1 BOX (74690-012-02) / 25 g in 1 TUBE1 tube2021-09-250000-00-00NoNoCurrent