Home NDC 53045-265 Ionite R
Product NDC 53045-265
11-digit product format 530450265
Labeler code 53045
Product ID 53045-265_ff676d2f-3188-4d27-b6a4-83e164154381
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride
Dosage form LIQUID
Route DENTAL; ORAL
Labeler Dharma Research, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2013-11-03
Substance SODIUM FLUORIDE
Active strength 38 g/L
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 53045-265 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53045-265 53045-265-64 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 R
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 38 g/L
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 251960 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53045-265-64 Ionite R 1.9 L in 1 BOTTLE, PUMP LIQUID 1.9 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53045-265 IONITE R (SODIUM FLUORIDE) LIQUID [DHARMA RESEARCH, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20201107_0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a5.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ionite R SODIUM FLUORIDE Dharma Research, Inc. 0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a5 2020-11-06 Warnings, Adverse reactions Exact identifier ndc (product): 53045-265
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53045-265-64 53045026564 1.9 L in 1 BOTTLE, PUMP (53045-265-64) 1.9 l 2013-11-03 0000-00-00 No No Current