Sodium Fluoride Oral Solution

Brand(s)
Fluor a Day, Flura-Drops
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Young Dental Manufacturing Co 1, Llc (2015-10-07)
Oldest Current Product
2003-09-11
License(s)
OTC MONOGRAPH FINAL, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
ORAL SOLUTION\SODIUM FLUORIDE
SPL Active
ORAL\LIQUID\SODIUM FLUORIDE
ORAL\RINSE\SODIUM FLUORIDE
ORAL\SOLUTION/DROPS\SODIUM FLUORIDE
ORAL\SOLUTION\SODIUM FLUORIDE
SPL Moiety
ORAL\LIQUID\FLUORIDE ION
ORAL\RINSE\FLUORIDE ION
ORAL\SOLUTION/DROPS\FLUORIDE ION
ORAL\SOLUTION\FLUORIDE ION

product(s) by strength(s)

sodium fluoride 0.02 ml/ml oral solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1002730348UNAPPROVED DRUG OTHER MARKETING CATEGORYYoung Dental Manufacturing Co 1, Llc2015-10-08SODIUM FLUORIDEORALSOLUTION3312267e-a1a0-4935-9edb-5792192018e7
2488783160UNAPPROVED DRUG OTHER MARKETING CATEGORY3M Espe Dental Products2013-05-17SODIUM FLUORIDEORALSOLUTION00c68fa6-ae49-4b73-bb71-5e960dc98368

sodium fluoride 0.5 mg/ml oral solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1247650100OTC MONOGRAPH FINALPharmacal-International. Co., Ltd.2011-12-01SODIUM FLUORIDEORALRINSEcc162a0e-b601-4466-9a4e-192985ee014a
2425070004OTC MONOGRAPH FINALHy-Vee2003-09-11SODIUM FLUORIDEORALRINSE684e86e0-afac-449b-93f1-39aef564c581
3553010004OTC MONOGRAPH FINALArmy + Air Force Exchange Service2011-02-09SODIUM FLUORIDEORALRINSE5f6f4125-6264-4724-bb7e-a6e100939b41

sodium fluoride 1.1 mg/ml oral solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1449461032UNAPPROVED DRUG OTHER MARKETING CATEGORYSancilio & Company Inc2011-12-20SODIUM FLUORIDEORALSOLUTION/DROPS01013faa-33e3-48a4-b710-d996fac43b61
2518620165UNAPPROVED DRUG OTHER MARKETING CATEGORYLibertas Pharma, Inc.2011-05-21SODIUM FLUORIDEORALSOLUTION/DROPS523ade1d-0bd9-42ba-94e8-647e665aa3e9

sodium fluoride 11 mg/ml oral solution

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1582230517Flura-DropsUNAPPROVED DRUG OTHER MARKETING CATEGORYKirkman Group, Inc.2014-05-01SODIUM FLUORIDEORALLIQUIDddb4c0d6-6739-2a4b-8a90-1c8aec94f4ab

sodium fluoride 2.2 mg/ml oral solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1002885523UNAPPROVED DRUG OTHER MARKETING CATEGORYFluoritab Corporation2011-01-09SODIUM FLUORIDEORALLIQUID2e05a9bf-f8e7-41b1-b382-2dc9d8dafee4

sodium fluoride 5.56 mg/ml oral solution

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1243380656Fluor a DayUNAPPROVED DRUG OTHER MARKETING CATEGORYArbor Pharmaceuticals, Inc.2010-08-15SODIUM FLUORIDEORALSOLUTION/DROPS4c854364-e732-4dec-b1d1-b8a97e4e1176

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
100c68fa6-ae49-4b73-bb71-5e960dc98368 (view SPL)These highlights do not include all the information needed to use 3MTM ESPETM Fluoride Treatment 2% Sodium Fluoride Aqueous Solution safely and effectively. See full prescribing information for Fluoride Treatment 2% Sodium Fluoride Aqueous Solution.Initial U.S. ApprovalprescriptionHuman Prescription3M Espe Dental ProductsMANUFACTURE2013-05-171488783160
201013faa-33e3-48a4-b710-d996fac43b61 (view SPL)Sodium Fluoride Drops 0.5 mg/mLprescriptionHuman PrescriptionSancilio & Company Inc2012-12-202449461032
32e05a9bf-f8e7-41b1-b382-2dc9d8dafee4 (view SPL)FLUORITAB FLUORIDE DROPS 1 fluid ounce sizeprescriptionHuman PrescriptionFluoritab Corporationanalysis, label, manufacture2011-05-0518002885523
43312267e-a1a0-4935-9edb-5792192018e7 (view SPL)Oral B Neutra FoamprescriptionHuman PrescriptionYoung Dental Manufacturing Co 1, Llcmanufacture2015-10-071002730348
54c854364-e732-4dec-b1d1-b8a97e4e1176 (view SPL)FLUORADAY Sodium Fluoride and XylitolprescriptionHuman PrescriptionArbor Pharmaceuticals, Inc.2010-08-151243380656, 243380602, 243380611, 243380622Sodium Fluoride / Xylitol Chewable Tablet
6523ade1d-0bd9-42ba-94e8-647e665aa3e9 (view SPL)Sodium Fluoride Drops 0.5 mg Drops Peach FlavoredprescriptionHuman PrescriptionLibertas Pharma, Inc.2011-05-211518620165
75f6f4125-6264-4724-bb7e-a6e100939b41 (view SPL)Drug FactsotcHuman OTCArmy + Air Force Exchange Servicemanufacture2015-08-212553010004
8684e86e0-afac-449b-93f1-39aef564c581 (view SPL)Drug FactsotcHuman OTCHy-Veemanufacture2011-01-311425070004
9cc162a0e-b601-4466-9a4e-192985ee014a (view SPL)Drug FactsotcHuman OTCPharmacal-International. Co., Ltd.2011-12-012247650100
10ddb4c0d6-6739-2a4b-8a90-1c8aec94f4ab (view SPL)FLURA-DROPS Sodium FluorideprescriptionHuman PrescriptionKirkman Group, Inc.MANUFACTURE2014-05-081582230517

Data from: LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII