Ionite R

Product NDC
53045-266
11-digit product format
530450266
Labeler code
53045
Product ID
53045-266_87ff143d-62ff-4b12-8800-ca730c2dce0a
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

Additional Listing Data#

Finished product
Yes
Brand name base
Ionite R
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE38 g/L

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui251960

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53045-266-642020-11-06C16284748780-19d75b9d0-4f12-f424-e053-dadaa90a57ce1009afc7-6e9d-417f-a702-f8a941e08484
53045-266-642020-01-31C16284748780-19d75b9d0-4f12-f424-e053-dadaa90a57ce1009afc7-6e9d-417f-a702-f8a941e08484

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53045-266-64Ionite R1.9 L in 1 BOTTLE, PUMPLIQUID1.92

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53045-266IONITE R (SODIUM FLUORIDE) LIQUID [DHARMA RESEARCH, INC.]2Current NDC, Legacy NDC, 1 package rows20201107_1009afc7-6e9d-417f-a702-f8a941e08484.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251960sodium fluoride 2 % Oral RinsePSN1009afc7-6e9d-417f-a702-f8a941e084842
251960sodium fluoride 20 MG/ML MouthwashSCD1009afc7-6e9d-417f-a702-f8a941e084842
251960sodium fluoride 2 % Oral RinseSY1009afc7-6e9d-417f-a702-f8a941e084842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53045-266-64530450266641.9 L in 1 BOTTLE, PUMP (53045-266-64) 1.9 l2013-11-030000-00-00NoNoCurrent