FDA.reportPublic FDA data

Ionite APF

Product NDC
53045-206
11-digit product format
530450206
Labeler code
53045
Product ID
53045-206_373417c2-b73d-4928-978a-ffa2b4b38746
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
DENTAL; ORAL
Labeler
Dharma Research, inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-01-01
Substance
SODIUM FLUORIDE
Active strength
6.027 g/490g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct53045-206IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53045-20653045-206-17IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53045-20653045-206-08IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
Ionite APF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE6.027 g/490g

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1535362Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53045-206-082020-11-10bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4
53045-206-172020-11-10bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4
53045-206-082020-01-31bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4
53045-206-172020-01-31bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53045-206-08Ionite APF245 g in 1 BOTTLEGEL2453
53045-206-17Ionite APF490 g in 1 BOTTLEGEL4903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
HYDROFLUORIC ACIDINACTIVE INGREDIENTRGL5YE86CZIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EIONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53045-206IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.]3Current NDC, Legacy NDC, 2 package rows20201117_bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4.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
Ionite APFSODIUM FLUORIDEDharma Research, inc.bc9664df-c4eb-4d29-b1c0-4d4dff6a75e42020-11-16WarningsExact identifier
ndc (product): 53045-206

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1535362sodium fluoride 2.72 % Oral GelPSNbc9664df-c4eb-4d29-b1c0-4d4dff6a75e43
1535362sodium fluoride 0.0272 MG/MG Oral GelSCDbc9664df-c4eb-4d29-b1c0-4d4dff6a75e43
1535362sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral GelSYbc9664df-c4eb-4d29-b1c0-4d4dff6a75e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53045-206-0853045020608245 g in 1 BOTTLE (53045-206-08) 245 g2013-01-010000-00-00NoNoCurrent
53045-206-1753045020617490 g in 1 BOTTLE (53045-206-17) 490 g2013-01-010000-00-00NoNoCurrent