Burkhart Neutral

Product NDC
43498-301
11-digit product format
434980301
Labeler code
43498
Product ID
43498-301_e270b080-56e5-4894-ad4f-01332c7baeaa
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
2019-02-11
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
1 g/120g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43498-301IInactivated by FDA2026-07-31
excluded packagepackage43498-30143498-301-04IInactivated by FDA2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43498-301-042022-01-28C16284748780-1d6a99b39-9e64-a426-e053-dadaa90af4c2de8b69a7-6d21-4ecf-a614-e78d7a0c2e97

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43498-301-04Burkhart Neutral120 g in 1 TUBEGEL1203

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7BURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OBURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1BURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
CASEININACTIVE INGREDIENT48268V50D5BURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWBURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95LBURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666BURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
WATERINACTIVE INGREDIENT059QF0KO0RBURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EBURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43498-301BURKHART NEUTRAL (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]3Legacy NDC, 1 package rows20190212_de8b69a7-6d21-4ecf-a614-e78d7a0c2e97.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43498-301-0443498030104120 g in 1 TUBE (43498-301-04) 120 g2019-02-110000-00-00NoNoCurrent