Fluoride ion - PharmaKB

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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New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Sodium fluoride

Triclosan

Tradename	Company	Number	Date	Products
COLGATE TOTAL	Colgate-Palmolive	N-020231 DISCN	1997-07-11	1 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
2080 k ginger mint	OTC monograph final	2017-01-10
2080 k herbal mint	OTC monograph final	2017-01-10
2080 k original	OTC monograph final	2017-04-26
365 whole foods market anticavity/antigingivitis mouthwash	OTC monograph not final	2022-05-12
3seconds magic gargle lemon	OTC monograph final	2020-02-09
3seconds magic gargle peach	OTC monograph final	2020-02-10
4 pack	C200263	2023-12-21
60 second fluoride gel	unapproved drug other	2022-01-24
60 second gel bubblegum 60 second gel grape 60 second gel mint 60 second gel orange cream 60 second gel strawberry	unapproved drug other	2017-02-14
60 second taste bubblegum	unapproved drug other	2022-12-19

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
bacterial infections and mycoses	—	D001423	—

Agency Specific

FDA

EMA

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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"]
Q9950	["Injection, sulfur hexafluoride lipid microspheres, per ml"]

Clinical

Clinical Trials

1091 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Dental caries	D003731	EFO_0003819	K02	31	41	50	39	220	367
Hypersensitivity	D006967	EFO_0003785	T78.40	9	20	24	16	79	139
Dentin sensitivity	D003807	—	—	7	17	21	13	83	134
Gingivitis	D005891	—	K05.10	3	8	20	20	49	99
Dental plaque	D003773	—	—	2	4	22	6	37	71
Prostatic neoplasms	D011471	—	C61	11	12	3	2	13	39
Neoplasms	D009369	—	C80	10	2	—	1	8	21
Oral hygiene	D009910	—	—	1	3	—	1	16	21
Dental enamel hypoplasia	D003744	EFO_1001304	—	2	3	2	1	15	20
Periodontitis	D010518	EFO_0000649	K05.3	—	1	4	5	8	18

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Tooth erosion	D014077	—	K03.2	—	2	3	—	8	13
Neoplasm metastasis	D009362	EFO_0009708	—	2	1	3	—	4	10
Bone neoplasms	D001859	EFO_0003820	D16	2	1	3	—	3	9
Infections	D007239	EFO_0000544	—	—	2	3	—	3	8
Mucositis	D052016	EFO_1001898	—	—	1	1	—	5	7
Heart arrest	D006323	EFO_0009492	I46	1	—	1	—	4	6
Communicable diseases	D003141	—	—	—	1	2	—	2	5
Bone marrow diseases	D001855	—	—	1	—	2	—	2	5
Gingival hemorrhage	D005884	—	—	—	—	2	—	2	4
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	—	1	1	—	1	3

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Carcinoma	D002277	—	C80.0	9	2	—	—	4	15
Root caries	D017213	EFO_1001163	—	3	1	—	—	12	15
Glioma	D005910	EFO_0000520	—	7	3	—	—	2	12
Fissure in ano	D005401	—	K60.2	—	1	—	—	11	12
Breast neoplasms	D001943	EFO_0003869	C50	5	3	—	—	3	10
Recurrence	D012008	—	—	4	2	—	—	4	10
Lung neoplasms	D008175	—	C34.90	6	2	—	—	2	9
Glioblastoma	D005909	EFO_0000515	—	5	2	—	—	1	8
Brain neoplasms	D001932	EFO_0003833	C71	4	1	—	—	2	7
Non-small-cell lung carcinoma	D002289	—	—	4	1	—	—	2	6

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Halitosis	D006209	—	R19.6	1	—	—	—	4	5
Hypoxia	D000860	—	R09.02	1	—	—	—	2	3
Colorectal neoplasms	D015179	—	—	2	—	—	—	1	3
Gliosarcoma	D018316	—	—	2	—	—	—	1	3
Ependymoma	D004806	—	—	2	—	—	—	1	3
Astrocytoma	D001254	EFO_0000271	—	2	—	—	—	1	3
Oligodendroglioma	D009837	EFO_0000631	—	2	—	—	—	1	3
Dental restoration failure	D019232	—	—	1	—	—	—	2	3
Fibrosis	D005355	—	—	1	—	—	—	2	3
Head and neck neoplasms	D006258	—	—	1	—	—	—	2	3

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Stroke	D020521	EFO_0000712	I63.9	—	—	—	—	6	6
Pneumonia	D011014	EFO_0003106	J18	—	—	—	—	4	4
Renal insufficiency	D051437	—	N19	—	—	—	—	4	4
Anemia	D000740	EFO_0004272	D64.9	—	—	—	—	3	3
Non-hodgkin lymphoma	D008228	—	C85.9	—	—	—	—	3	3
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	3	3
Aneurysm	D000783	—	I72.9	—	—	—	—	3	3
Aortic aneurysm	D001014	EFO_0001666	I71.9	—	—	—	—	3	3
Myocardial infarction	D009203	EFO_0000612	I21	—	—	—	—	3	3
Dental anxiety	D016854	—	—	—	—	—	—	3	3

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Fluoride
INN	pegamotecan
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