FDA.reportPublic FDA data

DentaGel

Product NDC
16571-815
Requested package NDC
16571-815-60
11-digit product format
165710815
Labeler code
16571
Product ID
16571-815_6ff13596-e232-4e07-bb60-b1d88a01b503
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium fluoride
Dosage form
GEL
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-05-09
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
DentaGel
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
1101938Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cda9e1f6-275d-43ba-9e30-f34094e80d95Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-815-60DentaGel56 g in 1 TUBEGEL561

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-815-60GM - Gram16571-8157399a870-33c6-4223-96d9-08fda0e0b8bf12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-815DENTAGEL (SODIUM FLUORIDE) GEL [RISING PHARMA HOLDINGS, INC.]1Current NDC, 1 package rows20230511_cda9e1f6-275d-43ba-9e30-f34094e80d95.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
DentaGelSODIUM FLUORIDERising Pharma Holdings, Inc.cda9e1f6-275d-43ba-9e30-f34094e80d952023-05-09Warnings, Adverse reactionsExact identifier
ndc (package): 16571-815-60
ndc (product): 16571-815
ndc11 (package): 16571081560

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101938Dentagel 1.1 % gel ToothpastePSNcda9e1f6-275d-43ba-9e30-f34094e80d951
392038sodium fluoride 1.1 % ToothpastePSNcda9e1f6-275d-43ba-9e30-f34094e80d951
1101938sodium fluoride 0.011 MG/MG Toothpaste [Dentagel]SBDcda9e1f6-275d-43ba-9e30-f34094e80d951
392038sodium fluoride 0.011 MG/MG ToothpasteSCDcda9e1f6-275d-43ba-9e30-f34094e80d951
1101938Dentagel 0.011 MG/MG ToothpasteSYcda9e1f6-275d-43ba-9e30-f34094e80d951
1101938Dentagel 1.1 % Dental GelSYcda9e1f6-275d-43ba-9e30-f34094e80d951
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYcda9e1f6-275d-43ba-9e30-f34094e80d951
392038sodium fluoride 1.1 % Dental GelSYcda9e1f6-275d-43ba-9e30-f34094e80d951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-815-601657108156056 g in 1 TUBE (16571-815-60) 56 g2023-05-09NoNoCurrent