Is Combe Incorporated FDA approved?

Combe Incorporated holds 2 FDA-registered establishments in the United States. 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 Combe Incorporated's drugs manufactured?

The FDA register lists Naguabo, PR; Rantoul, IL. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Combe Incorporated make?

8 products are listed under Combe Incorporated in the openFDA NDC Directory, most often as cream; cloth; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Combe Incorporated

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

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Registered sites: 2
Active NDC listings: 8
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing2Labelling2Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Combe Products, Inc.Registrant: Combe Incorporated	El Duque Und Park, Naguabo, Puerto Rico (PR) 00718, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	2650087091123992
Combe Laboratories, Inc.Registrant: Combe Incorporated	200 Shelhouse Drive, Rantoul, Illinois (IL) 61866, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1450238808100197

Catalogue

Drug listings by form and route

8 active NDC listings: 8 human otc drug. By marketing category: OTC MONOGRAPH DRUG 5, ANDA 3.

Dosage form	NDCs
cream	4
cloth	2
kit	1
ointment	1

Route	NDCs
topical	5
vaginal	2

Labeller name on the listing	NDCs
combe incorporated	8

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
VAGISIL Anti-Itch Creme Regular Strength	Benzocaine and Resorcinol	cream, topical	11509-5103OTC MONOGRAPH DRUG
VAGISIL Anti-Itch Medicated Creme Maximum Strength	Benzocaine and Resorcinol	cream, topical	11509-4402OTC MONOGRAPH DRUG
VAGISIL Anti-Itch Medicated Wipes Maximum Strength	pramoxine hydrochloride	cloth, topical	11509-5035OTC MONOGRAPH DRUG
VAGISIL Anti-Itch Medicated Wipes Maximum Strength	pramoxine hydrochloride	cloth, topical	11509-5058OTC MONOGRAPH DRUG
VAGISTAT	Tioconazole	ointment, vaginal	11509-0426ANDA
VAGISTAT 3	Miconazole nitrate	kit	11509-0081ANDA
Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula	Hydrocortisone Acetate	cream, topical	11509-5101OTC MONOGRAPH DRUG
vagisil brand vagistat	Miconazole nitrate	cream, vaginal	11509-0825ANDA

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Enquiry

Common questions

Is Combe Incorporated FDA approved?: Combe Incorporated holds 2 FDA-registered establishments in the United States. 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 Combe Incorporated's drugs manufactured?: The FDA register lists Naguabo, PR; Rantoul, IL. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Combe Incorporated make?: 8 products are listed under Combe Incorporated in the openFDA NDC Directory, most often as cream; cloth; kit. 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.