Burkhart

Product NDC
43498-100
11-digit product format
434980100
Labeler code
43498
Product ID
43498-100_d70d6555-4b3b-5832-e053-2995a90a1a55
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43498-100-15Burkhart454 g in 1 BOTTLE, PLASTICGEL4544

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43498-100BURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]4Current NDC, Legacy NDC, 1 package rows20220203_2531ad94-b229-4212-a7a3-f793567a06b6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43498-100-1543498010015454 g in 1 BOTTLE, PLASTIC (43498-100-15) 454 g2013-09-010000-00-00NoNoCurrent