Burkhart

Product NDC
43498-102
11-digit product format
434980102
Labeler code
43498
Product ID
43498-102_d66a3298-8b9b-2440-e053-2a95a90a2101
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
43498-102-15Burkhart454 g in 1 BOTTLE, PLASTICGEL4543

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 BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYBURKHART (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
43498-102BURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]3Current NDC, Legacy NDC, 1 package rows20220126_26b1f8ab-3540-4c3f-95ab-e9cb1c5cee97.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43498-102-1543498010215454 g in 1 BOTTLE, PLASTIC (43498-102-15) 454 g2013-09-010000-00-00NoNoCurrent