Primo APF

Product NDC
69509-056
11-digit product format
695090056
Labeler code
69509
Product ID
69509-056_d6080b18-4117-5384-e053-2a95a90a7df5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
DENTAL
Labeler
Tri State Dental
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-09-01
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
6 g/454g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69509-056-152025-01-30C16284748780-12cef2736-97ba-d83d-e063-dadaa90ab31f6681616d-c179-4af8-a0f4-2c1771759c1c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69509-056-15Primo APF454 g in 1 BOTTLE, PLASTICGEL4543

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
Magnesium Aluminum SilicateINACTIVE INGREDIENT6M3P64V0NCPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
WaterINACTIVE INGREDIENT059QF0KO0RPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1
XylitolINACTIVE INGREDIENTVCQ006KQ1EPRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69509-056PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]3Legacy NDC, 1 package rows20220121_6681616d-c179-4af8-a0f4-2c1771759c1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245593sodium fluoride 2 % Dental GelPSN6681616d-c179-4af8-a0f4-2c1771759c1c3
245593sodium fluoride 0.02 MG/MG Oral GelSCD6681616d-c179-4af8-a0f4-2c1771759c1c3
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSY6681616d-c179-4af8-a0f4-2c1771759c1c3
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSY6681616d-c179-4af8-a0f4-2c1771759c1c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69509-056-1569509005615454 g in 1 BOTTLE, PLASTIC (69509-056-15) 454 g2013-09-010000-00-00NoNoCurrent