Is GADAL Laboratories, Inc FDA approved?

GADAL 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 GADAL Laboratories, Inc's drugs manufactured?

The FDA register lists Miami, FL. Registered operations: finished drug manufacture.

What drugs does GADAL Laboratories, Inc make?

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

GADAL Laboratories, Inc

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

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 3
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
GADAL Laboratories, Inc	12178 SW 128th ST, Miami, Florida (FL) 33186, United States (USA)	Finished drug manufacture	3008611487841305639

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human otc drug. By marketing category: OTC MONOGRAPH DRUG 3.

Dosage form	NDCs
syrup	2
liquid	1

Route	NDCs
oral	3

Labeller name on the listing	NDCs
gadal laboratories, inc	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
DR. SANA COUGH AND CHEST CONGESTION DM	Dextromethorphan Hydrobromide, Guaifenesin	liquid, oral	53113-514OTC MONOGRAPH DRUG
DR. SANA PAIN AND FEVER FOR Children	Acetaminophen	syrup, oral	53113-516OTC MONOGRAPH DRUG
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE	Dextromethorphan Hydrobromide, Guaifenesin	syrup, oral	53113-515OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Ionetix CorporationMiami, FL · 2 sites
P & L Development, LLCMiami, FL
Prime Enterprises, LLC dba Prime Matter LabsMiami, FL
Medipharm Laboratories, IncMiami, FL
Advanced Generic CorporationMiami, FL
Aldama Pharmaceuticals IncMiami, FL
Alternative Pharmacal CorporationMiami, FL
Dextrum Laboratories Inc.Miami, FL
Dharma Research, Inc.Miami, FL
Fridababy, LLCMiami, FL
Germa Products LLCMIAMI, FL
Image Amazon LLCMiami, FL

Compare

Comparable companies in United States

Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals1 site · 4,853 NDC
NuCare Pharmaceuticals,Inc.1 site · 1,393 NDC
Greer Laboratories, Inc.1 site · 1,328 NDC
ASCLEMED USA INC. DBA ENOVACHEM1 site · 789 NDC
Golden State Medical Supply Inc.1 site · 670 NDC
Rising Pharma Holdings, Inc.1 site · 532 NDC
HF Acquisition Co LLC1 site · 363 NDC
ANI Pharmaceuticals, Inc.1 site · 299 NDC
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 site · 273 NDC
Newton Laboratories, Inc.1 site · 271 NDC

Enquiry

Common questions

Is GADAL Laboratories, Inc FDA approved?: GADAL 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 GADAL Laboratories, Inc's drugs manufactured?: The FDA register lists Miami, FL. Registered operations: finished drug manufacture.
What drugs does GADAL Laboratories, Inc make?: 3 products are listed under GADAL Laboratories, Inc in the openFDA NDC Directory, most often as syrup; 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.