Is Dextrum Laboratories Inc. FDA approved?

Dextrum 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 Dextrum Laboratories Inc.'s drugs manufactured?

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

What drugs does Dextrum Laboratories Inc. make?

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

Dextrum Laboratories Inc.

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

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Registered sites: 1
Active NDC listings: 22
Labeller names: 3
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Dextrum Laboratories Inc.	6993 NW 82 Avenue Unit # 20, Miami, Florida (FL) 33166, United States (USA)	Analytical testing, Finished drug manufacture, Repackaging	3003092372007392322

Catalogue

Drug listings by form and route

22 active NDC listings: 22 human otc drug. By marketing category: OTC MONOGRAPH DRUG 22.

Dosage form	NDCs
solution	11
liquid	7
spray	2
syrup	2

Route	NDCs
oral	21
topical	2

Labeller name on the listing	NDCs
dextrum laboratories inc.	11
dextrum laboratories, inc	10
dextrum laboratories inc	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Childrens Giltuss EX Expectorant	Guaifenesin	solution, oral	65852-016OTC MONOGRAPH DRUG
Childrens Giltuss Honey Cough and Chest Congestion	Dextromethorphan HBr, Guaifenesin	solution, oral	65852-003OTC MONOGRAPH DRUG
Childrens Giltuss Honey DM Cough	Dextromethorphan HBr	liquid, oral	65852-007OTC MONOGRAPH DRUG
Dometuss	Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCL	liquid, oral	65852-002OTC MONOGRAPH DRUG
Finafta MultiOral	Benzocaine	spray, oral	65852-001OTC MONOGRAPH DRUG
Giltuss Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	solution, oral	65852-017OTC MONOGRAPH DRUG
Giltuss Bucalsep	Benzocaine, Menthol, Zinc chloride	spray, oral, topical	65852-015OTC MONOGRAPH DRUG
Giltuss Childrens Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	solution, oral	65852-018OTC MONOGRAPH DRUG
Giltuss Childrens Cough and Chest Congestion	Dextromethorphan hydrobromide, Guaifenesin	solution, oral	65852-019OTC MONOGRAPH DRUG
Giltuss Childrens Cough and Cold	Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride	solution, oral	65852-011OTC MONOGRAPH DRUG
Giltuss Cough and Cold	Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride	solution, oral	65852-012OTC MONOGRAPH DRUG
Giltuss D	Giltuss D	syrup, oral	65852-010OTC MONOGRAPH DRUG
Giltuss Diabetic	Dextromethorphan hydrobromide, Guaifenesin	solution, oral	65852-009OTC MONOGRAPH DRUG
Giltuss EX Expectorant	Guaifenesin	solution, oral	65852-008OTC MONOGRAPH DRUG
Giltuss HBP Cough and Chest Congestion	Dextromethorphan hydrobromide, Guaifenesin	solution, oral	65852-006OTC MONOGRAPH DRUG
Giltuss Honey Cough and Chest Congestion	Dextromethorphan HBr, Guaifenesin	liquid, oral	65852-005OTC MONOGRAPH DRUG
Giltuss Honey DM Cough	Dextromethorphan HBr	solution, oral	65852-004OTC MONOGRAPH DRUG
IceQuake Lidocaine Analgesic	LIDOCAINE HYDROCHLORIDE	liquid, topical	65852-026OTC MONOGRAPH DRUG
Rompe Pecho CF	Brompheniramine Maleate, Dextromethorphan HBr	liquid, oral	65852-013OTC MONOGRAPH DRUG
Rycontuss	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	liquid, oral	65852-021OTC MONOGRAPH DRUG
SUPRESS A	Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl	syrup, oral	65852-020OTC MONOGRAPH DRUG
Sorbutuss NR	Sorbutuss	liquid, oral	68436-120OTC 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
Dharma Research, Inc.Miami, FL
Fridababy, LLCMiami, FL
GADAL Laboratories, IncMiami, FL
Germa Products LLCMIAMI, FL
Image Amazon LLCMiami, FL

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Enquiry

Common questions

Is Dextrum Laboratories Inc. FDA approved?: Dextrum 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 Dextrum Laboratories Inc.'s drugs manufactured?: The FDA register lists Miami, FL. Registered operations: analytical testing, finished drug manufacture, repackaging.
What drugs does Dextrum Laboratories Inc. make?: 22 products are listed under Dextrum Laboratories Inc. in the openFDA NDC Directory, most often as solution; liquid; spray. 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.