Is Riclan S.A. FDA approved?

Riclan S.A. holds 1 FDA-registered establishment in Brazil. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Riclan S.A.'s drugs manufactured?

The FDA register lists Rio Claro. Registered operations: finished drug manufacture, packaging.

What drugs does Riclan S.A. make?

11 products are listed under Riclan S.A. in the openFDA NDC Directory, most often as lozenge. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Riclan S.A.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 11
Live patents: 0
Countries: 1
Base: Brazil

Authorisation

Registered operations

Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Riclan S.A.	Avenida Brasil, 4801 - Distrito Industrial, Rio Claro, Sao Paulo 13505-600, Brazil (BRA)	Finished drug manufacture, Packaging	3013180029911989788

Catalogue

Drug listings by form and route

11 active NDC listings: 11 human otc drug. By marketing category: OTC MONOGRAPH DRUG 9, DRUG FOR FURTHER PROCESSING 2.

Dosage form	NDCs
lozenge	11

Route	NDCs
oral	9

Labeller name on the listing	NDCs
riclan s.a.	11

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Cough Drops Gems Flawless Cherry Flavor 30ct	MENTHOL	lozenge, oral	71165-032OTC MONOGRAPH DRUG
Cough Drops Gems Flawless Honey Lemon Flavor 30ct	MENTHOL	lozenge, oral	71165-033OTC MONOGRAPH DRUG
Freegells Cough Drops Menthol Cherry	MENTHOL	lozenge, oral	71165-011OTC MONOGRAPH DRUG
Freegells Cough Drops Menthol Eucalyptus	MENTHOL	lozenge, oral	71165-012OTC MONOGRAPH DRUG
Freegells Cough Drops Menthol Honey Lemon	MENTHOL	lozenge, oral	71165-013OTC MONOGRAPH DRUG
Freegells Cough Drops Menthol Strawberry	MENTHOL	lozenge, oral	71165-014OTC MONOGRAPH DRUG
Gems Cherry	Menthol	lozenge, oral	71165-172OTC MONOGRAPH DRUG
Gems Honey Lemon	Menthol	lozenge, oral	71165-171OTC MONOGRAPH DRUG
Gems Menthol Eucalyptus	Menthol	lozenge, oral	71165-173OTC MONOGRAPH DRUG
-	MENTHOL	lozenge	71165-020DRUG FOR FURTHER PROCESSING
-	MENTHOL	lozenge	71165-021DRUG FOR FURTHER PROCESSING

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Enquiry

Common questions

Is Riclan S.A. FDA approved?: Riclan S.A. holds 1 FDA-registered establishment in Brazil. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Riclan S.A.'s drugs manufactured?: The FDA register lists Rio Claro. Registered operations: finished drug manufacture, packaging.
What drugs does Riclan S.A. make?: 11 products are listed under Riclan S.A. in the openFDA NDC Directory, most often as lozenge. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.