Is Laboratorios Zepol S.A. FDA approved?

Laboratorios Zepol S.A. holds 1 FDA-registered establishment in Costa Rica. 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 Laboratorios Zepol S.A.'s drugs manufactured?

The FDA register lists Curridabat. Registered operations: finished drug manufacture.

What drugs does Laboratorios Zepol S.A. make?

7 products are listed under Laboratorios Zepol S.A. in the openFDA NDC Directory, most often as gel; ointment; cream. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Laboratorios Zepol S.A.

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

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Registered sites: 1
Active NDC listings: 7
Live patents: 0
Countries: 1
Base: Costa Rica

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Laboratorios Zepol S.A.	75 Mts al Norte del Servicentro La Galera, Curridabat, San Jose 3399-1000, Costa Rica (CRI)	Finished drug manufacture	3004637474853070985

Catalogue

Drug listings by form and route

7 active NDC listings: 7 human otc drug. By marketing category: OTC MONOGRAPH DRUG 5, UNAPPROVED HOMEOPATHIC 2.

Dosage form	NDCs
gel	3
ointment	3
cream	1

Route	NDCs
topical	7

Labeller name on the listing	NDCs
laboratorios zepol s.a.	7

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Manzatin Diaper Rash Skin Protectant	ZINC OXIDE	ointment, topical	55715-005OTC MONOGRAPH DRUG
Manzatin-E Diaper Rash Skin Protectant	Zinc Oxide	ointment, topical	55715-002OTC MONOGRAPH DRUG
Tree frog	COMFREY ROOT, ROSEMARY	gel, topical	55715-006UNAPPROVED HOMEOPATHIC
Tree frog	COMFREY ROOT, ROSEMARY	gel, topical	55715-007UNAPPROVED HOMEOPATHIC
Zany Antiseptic Gel	ALCOHOL	gel, topical	55715-004OTC MONOGRAPH DRUG
Zepol Topical Analgesic	Camphor, Menthol	ointment, topical	55715-001OTC MONOGRAPH DRUG
Zpol ULTRA	MENTHOL, METHYL SALICYLATE	cream, topical	55715-008OTC MONOGRAPH DRUG

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Common questions

Is Laboratorios Zepol S.A. FDA approved?: Laboratorios Zepol S.A. holds 1 FDA-registered establishment in Costa Rica. 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 Laboratorios Zepol S.A.'s drugs manufactured?: The FDA register lists Curridabat. Registered operations: finished drug manufacture.
What drugs does Laboratorios Zepol S.A. make?: 7 products are listed under Laboratorios Zepol S.A. in the openFDA NDC Directory, most often as gel; ointment; cream. 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.