Burkhart

Product NDC
43498-107
11-digit product format
434980107
Labeler code
43498
Product ID
43498-107_d70e60bc-60c2-c66c-e053-2a95a90a106f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
DENTAL
Labeler
Burkhart Dental Supply Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-12-14
Substance
SODIUM FLUORIDE
Active strength
5.6 g/454g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5.6 g/454g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43498-107-15Burkhart454 g in 1 BOTTLE, PLASTICGEL4544

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43498-107BURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]4Current NDC, Legacy NDC, 1 package rows20220203_8d1997c0-4f61-46b5-954e-620d521d3fba.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43498-107-1543498010715454 g in 1 BOTTLE, PLASTIC (43498-107-15) 454 g2013-09-010000-00-00NoNoCurrent