Fluoride
Dibasic, Monobasic, Monohydrate, Phosphate (fluoride) is a small molecule pharmaceutical. Fluoride was first approved as Sodium phosphates in plastic container on 1983-05-10.
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Commercial
Therapeutic Areas
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Trade Name
FDA
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Combinations
Phosphates (generic drugs available since 2011-12-30, discontinued: Osmoprep, Visicol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sodium phosphate
+
dibasic
+
anhydrous
+
Sodium phosphate
+
monobasic
+
monohydrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VISICOL | Salix Pharmaceuticals | N-021097 DISCN | 2000-09-21 | 1 products |
| OSMOPREP | Salix Pharmaceuticals | N-021892 DISCN | 2006-03-16 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 365 whole foods market anticavity/antigingivitis mouthwash | OTC monograph not final | 2022-05-12 |
| act anticavity fluoride kids bubblegum | C200263 | 2024-06-01 |
| act anticavity fluoride kids groovy grape | C200263 | 2024-06-01 |
| act kids anticavity fluoride pineapple punch | C200263 | 2024-06-01 |
| act kids pure protect anticavity- simply strawberry | C200263 | 2023-12-01 |
| act restoring anticavity fluoride cool mint | C200263 | 2024-07-01 |
| act total care anticavity fluoride fresh mint | C200263 | 2024-08-01 |
| advance white extreme whitening | C200263 | 2024-05-22 |
| aim cavity protection | OTC monograph final | 2023-01-19 |
| aim whitening | C200263 | 2024-01-02 |
Show 252 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacterial infections and mycoses | — | D001423 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sodium Phosphate, Dibasic, Anhydrous / Sodium Phosphate, Monobasic, Monohydrate, Osmoprep, Salix Pharms | |||
| 7687075 | 2028-06-22 | DS, DP | |
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AA: Caries prophylactic agents
— A01AA01: Sodium fluoride
— A01AA04: Stannous fluoride
— A01AA51: Sodium fluoride, combinations
— A12: Mineral supplements
— A12C: Other mineral supplements in atc
— A12CD: Fluoride supplements
— A12CD01: Sodium fluoride
— A12CD51: Fluoride, combinations
V: Various drug classes in atc
— V09: Diagnostic radiopharmaceuticals
— V09I: Tumour detection radiopharmaceuticals
— V09IX: Other diagnostic radiopharmaceuticals for tumour detection in atc
— V09IX06: Sodium fluoride (18f)
HCPCS
Code | Description |
|---|---|
| A9580 | Sodium fluoride f-18, diagnostic, per study dose, up to 30 millicuries |
| Level 3: D1206-D1208 | Topical Fluoride Treatment (office procedure) |
| Q9950 | Injection, sulfur hexafluoride lipid microspheres, per ml |
Clinical
Clinical Trials
5531 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 179 | 298 | 57 | 5 | 27 | 486 |
| Lymphoma | D008223 | — | C85.9 | 124 | 228 | 35 | 5 | 32 | 362 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 48 | 38 | 129 | 87 | 54 | 351 |
| Dental caries | D003731 | EFO_0003819 | K02 | 28 | 41 | 50 | 37 | 203 | 345 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 24 | 41 | 127 | 75 | 33 | 291 |
| Syndrome | D013577 | — | — | 63 | 131 | 30 | 24 | 42 | 261 |
| Myelodysplastic syndromes | D009190 | — | D46 | 76 | 143 | 17 | 1 | 16 | 222 |
| Myeloid leukemia | D007951 | — | C92 | 82 | 118 | 20 | 1 | 8 | 197 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 84 | 111 | 21 | 1 | 8 | 193 |
| Lymphoid leukemia | D007945 | — | C91 | 63 | 116 | 33 | 3 | 8 | 191 |
Show 601 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasma cell neoplasms | D054219 | — | — | 37 | 63 | 2 | — | 14 | 104 |
| Hodgkin disease | D006689 | — | C81 | 24 | 62 | 11 | — | 8 | 90 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 19 | 64 | 5 | — | 5 | 84 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 23 | 36 | 20 | — | 4 | 76 |
| Hematologic neoplasms | D019337 | — | — | 31 | 40 | 3 | — | 4 | 67 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 15 | 42 | 5 | — | 7 | 63 |
| Follicular lymphoma | D008224 | — | C82 | 24 | 40 | 4 | — | 7 | 62 |
| Mantle-cell lymphoma | D020522 | — | — | 27 | 38 | 3 | — | 6 | 61 |
| Graft vs host disease | D006086 | — | D89.81 | 11 | 39 | 9 | — | 3 | 55 |
| Small cell lung carcinoma | D055752 | — | — | 15 | 28 | 14 | — | 1 | 53 |
Show 338 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasmacytoma | D010954 | — | C90.3 | 16 | 32 | — | — | 9 | 53 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 13 | 25 | — | — | 7 | 39 |
| T-cell lymphoma cutaneous | D016410 | — | — | 8 | 16 | — | — | 7 | 28 |
| Mycosis fungoides | D009182 | — | C84.0 | 9 | 16 | — | — | 6 | 27 |
| Lymphomatoid granulomatosis | D008230 | — | C83.8 | 8 | 17 | — | — | 6 | 27 |
| Myeloid leukemia accelerated phase | D015465 | — | — | 5 | 20 | — | — | 3 | 26 |
| T-cell leukemia | D015458 | — | — | 7 | 16 | — | — | 5 | 25 |
| Sezary syndrome | D012751 | — | C84.1 | 7 | 15 | — | — | 6 | 25 |
| Adult t-cell leukemia-lymphoma | D015459 | — | C91.5 | 5 | 13 | — | — | 5 | 21 |
| Glioma | D005910 | EFO_0000520 | — | 9 | 9 | — | — | 2 | 19 |
Show 315 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tissue adhesions | D000267 | — | — | 1 | — | — | — | 6 | 7 |
| Dengue | D003715 | — | A90 | 6 | — | — | — | — | 6 |
| Pruritus | D011537 | HP_0000989 | L29 | 2 | — | — | — | 3 | 5 |
| Halitosis | D006209 | — | R19.6 | 1 | — | — | — | 4 | 5 |
| Aneurysm | D000783 | HP_0002617 | I72.9 | 1 | — | — | — | 3 | 4 |
| Dental restoration failure | D019232 | — | — | 1 | — | — | — | 3 | 4 |
| Impacted tooth | D014095 | HP_0011079 | K01.1 | 1 | — | — | — | 3 | 4 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | 1 | 3 |
| Autistic disorder | D001321 | HP_0000717 | F84.0 | 1 | — | — | — | 2 | 3 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | 1 | — | — | — | 2 | 3 |
Show 105 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Critical illness | D016638 | — | — | — | — | — | — | 5 | 5 |
| Sinus floor augmentation | D059546 | — | — | — | — | — | — | 5 | 5 |
| Aortic aneurysm | D001014 | EFO_0001666 | I71.9 | — | — | — | — | 4 | 4 |
| Graves disease | D006111 | EFO_0004237 | E05.0 | — | — | — | — | 3 | 3 |
| Abdominal aortic aneurysm | D017544 | EFO_0004214 | — | — | — | — | — | 3 | 3 |
| Acid-base imbalance | D000137 | — | — | — | — | — | — | 3 | 3 |
| Gingival recession | D005889 | — | K06.0 | — | — | — | — | 3 | 3 |
| Flatfoot | D005413 | EFO_0003874 | — | — | — | — | — | 3 | 3 |
| Mycoplasma pneumonia | D011019 | EFO_0007387 | J15.7 | — | — | — | — | 2 | 2 |
| Mycoplasma pneumoniae | D009177 | — | — | — | — | — | — | 2 | 2 |
Show 278 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fluoride |
| INN | — |
| Description | Fluorine F-18, Sodium Fluoride F 18 (fluoride) is a small molecule pharmaceutical. Fluoride was first approved as Fluorine F-18 on 1982-01-01. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | F |
Identifiers
| PDB | — |
| CAS-ID | 7664-39-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1232767 |
| ChEBI ID | 29228 |
| PubChem CID | 28179 |
| DrugBank | — |
| UNII ID | — |
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Fluoride
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
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Additional graphs summarizing 246,311 documents
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Safety
Black-box Warning
Black-box warning for: Osmoprep
Adverse Events
Top Adverse Reactions
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4,555 adverse events reported
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