Home NDC 53045-237 Ionite APF
Product NDC 53045-237
11-digit product format 530450237
Labeler code 53045
Product ID 53045-237_aed31a6c-2771-41cf-a35a-785e4a776366
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride
Dosage form GEL
Route DENTAL; ORAL; TOPICAL
Labeler Dharma Research, inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2013-01-01
Substance SODIUM FLUORIDE
Active strength 4.41 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 53045-237 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53045-237 53045-237-17 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…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
Brand name suffix Neutral
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 4.41 g/490g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53045-237-17 Ionite APFNeutral 490 g in 1 BOTTLE GEL 490 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE, DL- INACTIVE INGREDIENT WR1WPI7EW8 IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 HYDROFLUORIC ACID INACTIVE INGREDIENT RGL5YE86CZ IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53045-237 IONITE APF NEUTRAL (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20201028_8191554f-adb6-4ba9-aa80-0a9bb65193ec.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53045-237-17 53045023717 490 g in 1 BOTTLE (53045-237-17) 490 g 2013-01-01 0000-00-00 No No Current