sodium fluoride 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4243 7681-49-4

Description:

MoleculeDescription

Synonyms:

  • sodium fluoride
  • sodium monofluoride
A source of inorganic fluoride which is used topically to prevent dental caries.
  • Molecular weight: 41.99
  • Formula: FNa
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
1.10 mg O
88 mg O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
July 11, 1997 FDA COLGATE PALMOLIVE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Ototoxicity 26.76 17.94 7 2644 1355 63485016
Trifascicular block 23.09 17.94 4 2647 106 63486265
Hypoaesthesia eye 18.68 17.94 4 2647 328 63486043

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Respiratory tract infection bacterial 101.36 23.54 23 2021 1759 34953128
Respiratory tract infection viral 98.55 23.54 24 2020 2493 34952394
Cytokine release syndrome 77.61 23.54 34 2010 22843 34932044
Fibrin D dimer increased 63.76 23.54 19 2025 4225 34950662
Respiratory tract infection 62.66 23.54 28 2016 19684 34935203
Lymphoma 40.46 23.54 18 2026 12489 34942398
Eye infection 36.53 23.54 12 2032 3661 34951226
Somnambulism 34.47 23.54 11 2033 3061 34951826
Platelet count decreased 26.92 23.54 34 2010 119683 34835204
Sinusitis 24.73 23.54 20 2024 41382 34913505
COVID-19 24.05 23.54 26 2018 77524 34877363

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Respiratory tract infection bacterial 102.01 18.48 23 3856 2054 79738455
Respiratory tract infection viral 90.34 18.48 24 3855 4235 79736274
Cytokine release syndrome 87.09 18.48 40 3839 35958 79704551
Fibrin D dimer increased 53.85 18.48 19 3860 8635 79731874
Respiratory tract infection 41.16 18.48 27 3852 48662 79691847
Pulmonary embolism 23.60 18.48 35 3844 171619 79568890
Hypotension 22.39 18.48 59 3820 440258 79300251
Myelodysplastic syndrome 21.30 18.48 15 3864 30286 79710223
Myotonic dystrophy 21.21 18.48 4 3875 147 79740362
Lymphoma 20.64 18.48 12 3867 17448 79723061
Trifascicular block 20.49 18.48 4 3875 177 79740332
Ototoxicity 19.65 18.48 7 3872 3267 79737242
Platelet count decreased 19.01 18.48 34 3845 194630 79545879

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A01AA01 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Caries prophylactic agents
ATC A01AA51 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Caries prophylactic agents
ATC A12CD01 ALIMENTARY TRACT AND METABOLISM
MINERAL SUPPLEMENTS
OTHER MINERAL SUPPLEMENTS
Fluoride
MeSH PA D002327 Cariostatic Agents
MeSH PA D020011 Protective Agents
CHEBI has role CHEBI:25435 mutagens

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Vitamin deficiency indication 85670002
Prevention of dental caries indication 426482000
Gingivitis off-label use 66383009 DOID:3087
Dental Plaque Prevention off-label use
Constipation contraindication 14760008 DOID:2089
Dental fluorosis contraindication 30265004
Sarcoidosis contraindication 31541009 DOID:11335
Dehydration contraindication 34095006
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Kidney disease contraindication 90708001 DOID:557
Kidney stone contraindication 95570007
Osteolysis contraindication 203522001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
8ZYQ1474W7 UNII
4020179 VUID
N0000148121 NUI
D00943 KEGG_DRUG
4017647 VANDF
4017665 VANDF
4020179 VANDF
C0037508 UMLSCUI
CHEBI:28741 CHEBI
CHEMBL1528 ChEMBL_ID
5235 PUBCHEM_CID
DB09325 DRUGBANK_ID
D012969 MESH_DESCRIPTOR_UI
9873 RXNORM
1752 MMSL
4742 MMSL
5482 MMSL
001103 NDDF
329199009 SNOMEDCT_US
6910009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Oral-B NeutraCare Mint HUMAN PRESCRIPTION DRUG LABEL 1 0041-0241 GEL 11 mg DENTAL unapproved drug other 18 sections
Oral-B Minute-Foam Banana Splitz HUMAN PRESCRIPTION DRUG LABEL 1 0041-0340 AEROSOL 10 mg DENTAL unapproved drug other 18 sections
Oral-B Minute-Foam Mellow Mint HUMAN PRESCRIPTION DRUG LABEL 1 0041-0341 AEROSOL 10 mg DENTAL unapproved drug other 18 sections
Oral-B Minute-Foam Orang-A-Tangy HUMAN PRESCRIPTION DRUG LABEL 2 0041-0342 AEROSOL 10 mg DENTAL unapproved drug other 18 sections
Oral-B Minute-Foam Bubble Gum HUMAN PRESCRIPTION DRUG LABEL 1 0041-0345 AEROSOL 10 mg DENTAL unapproved drug other 18 sections
Oral-B Minute-Foam Strawberry HUMAN PRESCRIPTION DRUG LABEL 1 0041-0346 AEROSOL 10 mg DENTAL unapproved drug other 18 sections
Oral-B Minute-Foam Grape Punch HUMAN PRESCRIPTION DRUG LABEL 1 0041-0347 AEROSOL 10 mg DENTAL unapproved drug other 18 sections
Oral-B Neutra-Foam Mint HUMAN PRESCRIPTION DRUG LABEL 1 0041-0348 AEROSOL 9 mg DENTAL unapproved drug other 18 sections
Oral-B Anticavity HUMAN OTC DRUG LABEL 1 0041-1421 LIQUID 500 ug DENTAL OTC monograph not final 26 sections
PreviDent 5000 Dry Mouth HUMAN PRESCRIPTION DRUG LABEL 1 0126-0016 GEL, DENTIFRICE 6.10 mg DENTAL UNAPPROVED DRUG OTHER 20 sections
PreviDent 5000 Dry Mouth HUMAN PRESCRIPTION DRUG LABEL 1 0126-0016 GEL, DENTIFRICE 6.10 mg DENTAL UNAPPROVED DRUG OTHER 20 sections
PreviDent 5000 Enamel Protect HUMAN PRESCRIPTION DRUG LABEL 2 0126-0022 GEL, DENTIFRICE 5.80 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent 5000 Enamel Protect HUMAN PRESCRIPTION DRUG LABEL 2 0126-0022 GEL, DENTIFRICE 5.80 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride HUMAN OTC DRUG LABEL 1 0126-0032 RINSE 2 mg DENTAL OTC MONOGRAPH FINAL 11 sections
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride HUMAN OTC DRUG LABEL 1 0126-0032 RINSE 2 mg DENTAL OTC MONOGRAPH FINAL 11 sections
PreviDent Alcohol Free HUMAN PRESCRIPTION DRUG LABEL 1 0126-0033 MOUTHWASH 0.90 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent Alcohol Free HUMAN PRESCRIPTION DRUG LABEL 1 0126-0033 MOUTHWASH 0.90 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride HUMAN OTC DRUG LABEL 1 0126-0034 RINSE 2 mg DENTAL OTC MONOGRAPH FINAL 11 sections
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride HUMAN OTC DRUG LABEL 1 0126-0034 RINSE 2 mg DENTAL OTC MONOGRAPH FINAL 11 sections
PreviDent 5000 Sensitive HUMAN PRESCRIPTION DRUG LABEL 2 0126-0070 GEL, DENTIFRICE 5.80 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent 5000 Sensitive HUMAN PRESCRIPTION DRUG LABEL 2 0126-0070 GEL, DENTIFRICE 5.80 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent 5000 Booster Plus Fruitastic HUMAN PRESCRIPTION DRUG LABEL 1 0126-0072 PASTE, DENTIFRICE 6 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent 5000 Booster Plus Fruitastic HUMAN PRESCRIPTION DRUG LABEL 1 0126-0072 PASTE, DENTIFRICE 6 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent 5000 Booster Plus Fruitastic HUMAN PRESCRIPTION DRUG LABEL 1 0126-0072 PASTE, DENTIFRICE 6 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PrevidDent 5000 Booster Plus Spearmint HUMAN PRESCRIPTION DRUG LABEL 1 0126-0074 PASTE, DENTIFRICE 6 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PrevidDent 5000 Booster Plus Spearmint HUMAN PRESCRIPTION DRUG LABEL 1 0126-0074 PASTE, DENTIFRICE 6 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent Fresh Mint HUMAN PRESCRIPTION DRUG LABEL 1 0126-0088 GEL, DENTIFRICE 5 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent Fresh Mint HUMAN PRESCRIPTION DRUG LABEL 1 0126-0088 GEL, DENTIFRICE 5 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent Fresh Mint HUMAN PRESCRIPTION DRUG LABEL 1 0126-0088 GEL, DENTIFRICE 5 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent 5000 Plus Fruitastic HUMAN PRESCRIPTION DRUG LABEL 1 0126-0286 PASTE, DENTIFRICE 11 mg DENTAL UNAPPROVED DRUG OTHER 21 sections