Choline salicylate

Overview

Choline salicylate is an anti-inflammatory pain reliever agent that is related to aspirin. It is used to decrease swelling and to treat mild-moderate pain. It is used to treat arthritis in both children and adults. This medicine can also be used for fever . Choline Salicylate is the choline salt of salicylic acid, used as an analgesic, antipyretic and antirheumatic. It relieves mild to moderate pain and reduce fever and inflammation or swelling. Choline salicylate is effective in the treatment of gout, rheumatic fever, rheumatoid arthritis and muscle injuries . This drug is also a main ingredient in teething gels to relieve pains associated with tooth growth in the infant population . The UK government has regulated its use, due to toxicity in those under 16 years of age. Topical oral salicylate gels are no longer indicated for people younger than 16 years for pain associated with infant teething, orthodontic devices, cold sores, or mouth ulcers .

Indication

The oral gel is indicated for the relief of pain and discomfort of common mouth ulcers, cold sores, denture sore spots, infant teething and mouth ulcers, and sore spots due to orthodontic devices in children .

Associated Conditions

Back pain
Cold Sore
Cough
Epiphora
Fever
Headache
Infection
Inflammation of Mouth
Myalgia
Nasal Congestion
Pain
Rhinorrhoea
Sneezing
Sore Throat
Teething pain
Wound of the Oral Cavity
Cold or flu syndrome
Minor aches and pains
Minor pain
Ulceration of the mouth

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple Myeloma	2020/11/23	NCT04640779	Phase 1	Recruiting	Mayo Clinic

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
SORAGEL ANTISEPTIC PAIN RELIEVING ORAL GEL	ICM PHARMA PTE. LTD.	SIN10428P	GEL	8.7% w/w	11/16/1998
ORA-SED JEL	HAMILTON PHARMACEUTICAL PTY LTD	SIN04948P	GEL	0.09 ml/ml	7/16/1990
BONJELA GEL	RECKITT BENCKISER HEALTHCARE (UK) LTD	SIN04303P	GEL	8.714% W/W	4/23/1990

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
FAIR-WAY GEL	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	1/30/1992
ORIS-GEL	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	9/20/1988
OROJEL ORAL GEL	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	10/17/1989
ORO-SEP GEL	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	1/30/1992
ULC-AID GEL	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	6/16/1999

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NYAL MOUTH ULCER GEL tube	16132	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	10/3/1991
BONJELA TEETHING & MOUTH ULCER GEL choline salicylate 87 mg/g tube	10322	Reckitt Benckiser Pty Ltd	Medicine	A	7/4/1991
PHARMACY SELECT BABY TEETHING GEL tube	39770	Petrus Pharmaceuticals Pty Ltd	Medicine	A	4/27/1992
SEDAGEL gel tube	18898	Key Pharmaceuticals Pty Ltd	Medicine	A	9/30/1991
SOUL PATTINSON TEETHING GEL choline salicylate 87mg/g tube	69221	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	6/10/1999
BONJELA MOUTH ULCER & TEETHING GEL choline salicylate 87 mg/g tube	121203	Reckitt Benckiser Pty Ltd	Medicine	A	8/8/2005
BUBS & CO TEETHING GEL choline salicylate 87 mg/g tube	339845	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	7/20/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TRILISATE TAB	purdue pharma	00449636	Tablet - Oral	293 MG	12/31/1979
TEEJEL GEL	purdue pharma	00026190	Gel - Topical , Dental	8.7 %	12/31/1965

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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