FDA.reportPublic FDA data

Denta 5000 Plus

Product NDC
16571-814
Requested package NDC
16571-814-50
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
392038Internal RxNorm lookup
630196Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7142eb93-54ff-4ba1-af43-3fa3dc1fad01Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Denta 5000 PlusSODIUM FLUORIDERising Pharma Holdings, Inc.7142eb93-54ff-4ba1-af43-3fa3dc1fad012023-07-17Warnings, Adverse reactionsExact identifier
ndc (package): 16571-814-50
ndc (product): 16571-814
ndc11 (package): 16571081450

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 g2023-07-03NoNoCurrent