Burkhart Neutral pH

Product NDC
43498-151
11-digit product format
434980151
Labeler code
43498
Product ID
43498-151_d70d625c-edfa-6184-e053-2a95a90ac93a
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 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
43498-151-15Burkhart Neutral pH454 g in 1 BOTTLE, PLASTICGEL4543

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7BURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OBURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Magnesium Aluminum SilicateINACTIVE INGREDIENT6M3P64V0NCBURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNBURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHBURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUBURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPBURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
WaterINACTIVE INGREDIENT059QF0KO0RBURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEBURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
XylitolINACTIVE INGREDIENTVCQ006KQ1EBURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43498-151BURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]3Current NDC, Legacy NDC, 1 package rows20220203_0fb4d584-36e8-4db7-b72e-04608580dacd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245593sodium fluoride 2 % Dental GelPSN0fb4d584-36e8-4db7-b72e-04608580dacd3
245593sodium fluoride 0.02 MG/MG Oral GelSCD0fb4d584-36e8-4db7-b72e-04608580dacd3
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSY0fb4d584-36e8-4db7-b72e-04608580dacd3
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSY0fb4d584-36e8-4db7-b72e-04608580dacd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43498-151-1543498015115454 g in 1 BOTTLE, PLASTIC (43498-151-15) 454 g2013-09-010000-00-00NoNoCurrent