Burkhart Neutral pH

Product NDC
43498-150
11-digit product format
434980150
Labeler code
43498
Product ID
43498-150_d70d52c0-65f1-f632-e053-2995a90a9291
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
4.086 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 Neutral pH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE4.086 g/454g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui245593

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43498-150-15Burkhart Neutral pH454 g in 1 BOTTLE, PLASTICGEL4543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43498-150BURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]3Current NDC, Legacy NDC, 1 package rows20220203_a7259222-4ee1-42b2-8beb-3f29a5eb2909.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245593sodium fluoride 2 % Dental GelPSNa7259222-4ee1-42b2-8beb-3f29a5eb29093
245593sodium fluoride 0.02 MG/MG Oral GelSCDa7259222-4ee1-42b2-8beb-3f29a5eb29093
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSYa7259222-4ee1-42b2-8beb-3f29a5eb29093
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSYa7259222-4ee1-42b2-8beb-3f29a5eb29093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43498-150-1543498015015454 g in 1 BOTTLE, PLASTIC (43498-150-15) 454 g2013-09-010000-00-00NoNoCurrent