Is Summers Laboratories Inc FDA approved?

Summers Laboratories Inc holds 1 FDA-registered establishment 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 Summers Laboratories Inc's drugs manufactured?

The FDA register lists Collegeville, PA. Registered operations: finished drug manufacture.

What drugs does Summers Laboratories Inc make?

2 products are listed under Summers Laboratories Inc in the openFDA NDC Directory, most often as gel; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Summers Laboratories Inc

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

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Summers Laboratories Inc	103 G P Clement Dr, Collegeville, Pennsylvania (PA) 19426, United States (USA)	Finished drug manufacture	1000121375002382612

Catalogue

Drug listings by form and route

2 active NDC listings: 1 human otc drug, 1 human prescription drug. By marketing category: OTC MONOGRAPH DRUG 1, UNAPPROVED DRUG OTHER 1.

Dosage form	NDCs
gel	1
liquid	1

Route	NDCs
topical	2

Labeller name on the listing	NDCs
summers laboratories inc	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Keralyt	salicylic acid	gel, topical	11086-030UNAPPROVED DRUG OTHER
LIQUIMAT ACNE TREATMENT AND COVER-UP	SULFUR	liquid, topical	11086-028OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is Summers Laboratories Inc FDA approved?: Summers Laboratories Inc holds 1 FDA-registered establishment 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 Summers Laboratories Inc's drugs manufactured?: The FDA register lists Collegeville, PA. Registered operations: finished drug manufacture.
What drugs does Summers Laboratories Inc make?: 2 products are listed under Summers Laboratories Inc in the openFDA NDC Directory, most often as gel; liquid. 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.