Emmi-dent Whitening

Product NDC
63956-003
11-digit product format
639560003
Labeler code
63956
Product ID
63956-003_407a5a0e-64d8-43cb-8d24-644261870049
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
EMAG AG
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-30
Substance
SODIUM FLUORIDE
Active strength
320 mg/75mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE320 mg/75mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63956-003-03Emmi-dent Whitening75 mL in 1 TUBEPASTE, DENTIFRICE754
63956-003-03Emmi-dent Whitening1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63956-003EMMI-DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [EMAG AG]4Current NDC, Legacy NDC, 2 package rows20241220_dbc0cfe0-24ef-4ee2-b975-4044624a592f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63956-003-03639560003031 TUBE in 1 CARTON (63956-003-03) / 75 mL in 1 TUBE1 tube2019-07-300000-00-00NoNoCurrent