Sodium fluorophosphate

Generic Name: Sodium fluorophosphate

Drug Type: Small Molecule

Chemical Formula: FNa_₂O_₃P

CAS Number: 10163-15-2

Unique Ingredient Identifier: C810JCZ56Q

Overview

Sodium monofluorophosphate is used in OTC dental preparations to help protect against cavities.

Indication

Sodium monofluorophosphate is indicated for the treatment of cavities

Associated Conditions

Dental Cavity

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride	2019/10/11	NCT04123665	Phase 3	Completed	GlaxoSmithKline
The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity	2017/03/07	NCT03072719	Phase 3	Completed	GlaxoSmithKline
Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity	2016/07/14	NCT02832375	Phase 3	Completed	GlaxoSmithKline
Potential of Stannous Fluoride Toothpaste to Reduce Gum Disease	2016/04/26	NCT02750943	Not Applicable	Completed	GlaxoSmithKline
Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity	2013/04/09	NCT01827670	Phase 3	Completed	GlaxoSmithKline
Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity	2012/05/07	NCT01592851	Phase 3	Completed	GlaxoSmithKline
The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity	2012/05/07	NCT01592864	Phase 3	Completed	GlaxoSmithKline
Investigation of Dental Plaque and Gingival Index	2008/09/25	NCT00759031	Phase 3	Completed	Colgate Palmolive

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
KarlnHans Fresh Breath Jasmine Mint	PIGEON CORPORATION	78151-090	TOPICAL	0.74 g in 100 g	6/23/2025
DENTI BOUNGIORNO ORIGINAL TOOTH	ATOSAFE CO., Ltd	85601-010	ORAL	0.76 g in 100 g	5/7/2025
KarlnHans Fresh Breath Double Mint	PIGEON CORPORATION	78151-100	TOPICAL	0.74 g in 100 g	6/23/2025
Brush Buddies Value 2 pack Whitening	Ashtel Studios, Inc	70108-030	DENTAL	0.76 g in 100 g	4/30/2025
Optimax Anticavity Fluoride Watermelon	WHITE GLO USA INC	73656-032	DENTAL	7.6 mg in 1 g	5/12/2025
Whitening	Target	11673-385	DENTAL	0.14 g in 100 g	1/24/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Colgate Sensitive Enamel Protect Toothpaste	165215	Colgate-Palmolive Pty Ltd	Medicine	A	9/12/2009
Zero Mint Toothpaste	421343	Mischler Group	Medicine	A	9/6/2023
Colgate Sensitive Whitening Toothpaste	125708	Colgate-Palmolive Pty Ltd	Medicine	A	2/24/2006
Zero Mint Toothpaste	421420	Mischler Group	Medicine	A	9/7/2023
Colgate Sensitive Multiprotection Toothpaste	126902	Colgate-Palmolive Pty Ltd	Medicine	A	4/10/2006
CEDEL SENSITIVE TOOTHPASTE	163473	Ensign Laboratories Pty Ltd	Medicine	A	7/17/2009
Darlie Expert Gum Care Odour Control Toothpaste	303706	SWA Biopharm Pty Ltd	Medicine	A	5/30/2018
NEO PRO SENSITIVE TOOTHPASTE	454430	Neo Health (OTC) Pty Ltd	Medicine	A	7/4/2024

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
AQUAFRESH ADVANCED CLEAN MINT TOOTHPASTE (PUMP)	glaxosmithkline consumer healthcare ulc	02247198	Toothpaste - Dental	0.836 %	3/1/2004
VIADENT ANTI-PLAQUE TOOTHPASTE W FLUO	vipont pharmacetical inc.	01946331	Toothpaste - Dental	.8 %	12/31/1993
AQUAFRESH REG TOOTHPASTE (PUMP) 0.8%	smithkline beecham consumer healthcare, division of smithkline beecham inc.	01942697	Toothpaste - Dental	.8 %	12/31/1992
PROFESSIONAL CHOICE WHITENING TOOTHPASTE	plak smacker	02237062	Toothpaste - Oral	0.76 %	N/A
TOPOL PLUS WITH CALCIUM	dep corporation	02236836	Paste - Dental	0.83 %	10/28/1998
PEARL DROPS STAINFIGHTING EXTRA STGTH TPT.8%	carter products, division of carter wallace ns inc.	02020505	Toothpaste - Dental	.8 %	12/31/1993
PEARL DROPS TOOTHPOLISH REGULAR - SUS 0.8%	carter-horner corp.	02222086	Suspension - Dental	.8 %	5/4/1998
GREAT WHITE SHARK CHILDREN'S WHITENING TOOTHPASTE	plak smacker	02237061	Toothpaste - Oral	0.76 %	N/A
AIM	church & dwight canada corp	02240042	Toothpaste - Dental	0.80 %	11/1/1999
PEARL DROPS STAINFIGHTING EXTRA STR.TOOTHP.	carter-horner corp.	02222434	Toothpaste - Dental	.8 %	12/31/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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