Burkhart

Product NDC
43498-105
11-digit product format
434980105
Labeler code
43498
Product ID
43498-105_d70e56fb-58be-0593-e053-2a95a90a661a
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
43498-105-15Burkhart454 g in 1 BOTTLE, PLASTICGEL4544

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7BURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Magnesium Aluminum SilicateINACTIVE INGREDIENT6M3P64V0NCBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
WaterINACTIVE INGREDIENT059QF0KO0RBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
XylitolINACTIVE INGREDIENTVCQ006KQ1EBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43498-105BURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]4Current NDC, Legacy NDC, 1 package rows20220203_192c4e46-0bfd-4f48-901c-ce4f09f91e3e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43498-105-1543498010515454 g in 1 BOTTLE, PLASTIC (43498-105-15) 454 g2013-09-010000-00-00NoNoCurrent