Denta 5000 Plus

Product NDC
16571-814
11-digit product format
165710814
Labeler code
16571
Product ID
16571-814_82dc4f9f-0dc5-46f8-8deb-3966669470cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium fluoride
Dosage form
CREAM
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-07-03
Substance
SODIUM FLUORIDE
Active strength
1.1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Denta 5000 Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui392038, 630196

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-814-50Denta 5000 Plus51 g in 1 TUBECREAM511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-814-50GM - Gram16571-814131ce459-3fde-4661-94d4-5f2eef0150ea12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-814DENTA 5000 PLUS (SODIUM FLUORIDE) CREAM [RISING PHARMA HOLDINGS, INC.]1Current NDC, 1 package rows20230718_7142eb93-54ff-4ba1-af43-3fa3dc1fad01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630196DENTA 5000 PLUS 1.1 % ToothpastePSN7142eb93-54ff-4ba1-af43-3fa3dc1fad011
392038sodium fluoride 1.1 % ToothpastePSN7142eb93-54ff-4ba1-af43-3fa3dc1fad011
630196sodium fluoride 0.011 MG/MG Toothpaste [Denta 5000 Plus]SBD7142eb93-54ff-4ba1-af43-3fa3dc1fad011
392038sodium fluoride 0.011 MG/MG ToothpasteSCD7142eb93-54ff-4ba1-af43-3fa3dc1fad011
630196Denta 5000 Plus 0.011 MG/MG ToothpasteSY7142eb93-54ff-4ba1-af43-3fa3dc1fad011
630196Denta 5000 Plus 1.1 % Cream ToothpasteSY7142eb93-54ff-4ba1-af43-3fa3dc1fad011
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY7142eb93-54ff-4ba1-af43-3fa3dc1fad011
392038sodium fluoride 1.1 % Dental GelSY7142eb93-54ff-4ba1-af43-3fa3dc1fad011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-814-501657108145051 g in 1 TUBE (16571-814-50) 51 g2023-07-03NoNoHistorical