Is Llorens Pharmaceutical International Division, Inc. FDA approved?

Llorens Pharmaceutical International Division, 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 Llorens Pharmaceutical International Division, Inc.'s drugs manufactured?

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

What drugs does Llorens Pharmaceutical International Division, Inc. make?

29 products are listed under Llorens Pharmaceutical International Division, Inc. in the openFDA NDC Directory, most often as liquid; solution/ drops; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Llorens Pharmaceutical International Division, Inc.

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

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Registered sites: 1
Active NDC listings: 29
Labeller names: 3
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Llorens Pharmaceutical International Division, Inc.	7080 NW 37TH CT, Miami, Florida (FL) 33147, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3008468946037342305

Catalogue

Drug listings by form and route

29 active NDC listings: 29 human otc drug. By marketing category: OTC MONOGRAPH DRUG 29.

Dosage form	NDCs
liquid	22
solution/ drops	3
tablet	2
cream	1
suspension	1

Route	NDCs
oral	26
topical	3

Labeller name on the listing	NDCs
llorens pharmaceutical international division, inc.	12
llorens pharmaceuticals international division	9
llorens pharmaceutical international division	8

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Allergy Relief	Diphenhydramine HCl	liquid, oral	54859-811OTC MONOGRAPH DRUG
Allergy Relief	Diphenhydramine HCl	liquid, oral	54859-837OTC MONOGRAPH DRUG
Amino Rip Muscle Pain Relief	Lidocaine HCl	liquid, topical	54859-415OTC MONOGRAPH DRUG
Conex	Dexbrompheniramine Maleate, Pseudoephedrine HCl	liquid, oral	54859-812OTC MONOGRAPH DRUG
Conex Pediatric	Dexbrompheniramine Maleate, Pseudoephedrine HCl	liquid, oral	54859-803OTC MONOGRAPH DRUG
Dermagesic	Pramoxine HCl, Zinc Oxide, Calamine	cream, topical	54859-202OTC MONOGRAPH DRUG
Docusate Sodium Liquid	Docusate Sodium	liquid, oral	54859-813OTC MONOGRAPH DRUG
Dologesic DF	Acetaminophen, Dexbrompheniramine Maleate	tablet, oral	54859-010OTC MONOGRAPH DRUG
Dologesic NF	Acetaminophen, Dexbrompheniramine Maleate	tablet, oral	54859-001OTC MONOGRAPH DRUG
Dologesic Roll-On	Lidocaine Hcl	liquid, topical	54859-513OTC MONOGRAPH DRUG
Limpia Pecho	Dextromethorphan HBr, Guaifenesin	liquid, oral	54859-011OTC MONOGRAPH DRUG
Liquid Acetaminophen	Acetaminophen	liquid, oral	54859-809OTC MONOGRAPH DRUG
Llorens Care Children Acetaminophen	ACETAMINOPHEN	suspension, oral	54859-850OTC MONOGRAPH DRUG
Llorens Care Tussin	Guaifenesin	liquid, oral	54859-510OTC MONOGRAPH DRUG
Llorens Care Tussin DM	Dextromethorphan HBr, Guaifenesin	liquid, oral	54859-833OTC MONOGRAPH DRUG
Senna Syrup	Sennosides	liquid, oral	54859-808OTC MONOGRAPH DRUG
Triponel	Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl	liquid, oral	54859-508OTC MONOGRAPH DRUG
Triponel	Dextromethorphan HBr, Pseufoephedrine HCl, Triprolidine HCl	liquid, oral	54859-514OTC MONOGRAPH DRUG
Tusnel	Dextromethorphan, Guiafenesin, Pseudoephedrine HCl	liquid, oral	54859-502OTC MONOGRAPH DRUG
Tusnel Cough Suppressant Expectorant	Dextromethorphan HBr, Guaifenesin	liquid, oral	54859-509OTC MONOGRAPH DRUG
Tusnel DM	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl	liquid, oral	54859-517OTC MONOGRAPH DRUG
Tusnel DM Pediatric	Dextromethorphan, Guiafenesin, Pseudoephedrine HCl	solution/ drops, oral	54859-603OTC MONOGRAPH DRUG
Tusnel Diabetic	Dextromethorphan, Guaifenesin	liquid, oral	54859-505OTC MONOGRAPH DRUG
Tusnel EX	Guaifenesin	liquid, oral	54859-507OTC MONOGRAPH DRUG
Tusnel Pediatric	Dextromethorphan, Guiafenesin, Pseudoephedrine HCl	liquid, oral	54859-544OTC MONOGRAPH DRUG
Tusnel Pediatric DM	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl	liquid, oral	54859-604OTC MONOGRAPH DRUG
Tusnel Pediatric Drops	Guaifenesin, Phenylephrine HCl	solution/ drops, oral	54859-605OTC MONOGRAPH DRUG
Tusnel SF	Dextromethorphan HBr, Guaifenesin	liquid, oral	54859-506OTC MONOGRAPH DRUG
Tusnel-DM Pediatric	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl	solution/ drops, oral	54859-606OTC 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
GADAL Laboratories, IncMiami, FL
Germa Products LLCMIAMI, FL

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Enquiry

Common questions

Is Llorens Pharmaceutical International Division, Inc. FDA approved?: Llorens Pharmaceutical International Division, 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 Llorens Pharmaceutical International Division, Inc.'s drugs manufactured?: The FDA register lists Miami, FL. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Llorens Pharmaceutical International Division, Inc. make?: 29 products are listed under Llorens Pharmaceutical International Division, Inc. in the openFDA NDC Directory, most often as liquid; solution/ drops; tablet. 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.