Is LNK International, Inc. FDA approved?

LNK International, 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 LNK International, Inc.'s drugs manufactured?

The FDA register lists Central Islip, NY. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does LNK International, Inc. make?

64 products are listed under LNK International, Inc. in the openFDA NDC Directory, most often as tablet, film coated; tablet; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

LNK International, Inc.

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

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Registered sites: 1
Active NDC listings: 63
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
LNK International, Inc.	250 Creative Drive, Central Islip, New York (NY) 11722, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	2432212118905797

Catalogue

Drug listings by form and route

63 active NDC listings: 62 human otc drug, 1 bulk ingredient. By marketing category: OTC MONOGRAPH DRUG 41, ANDA 21, BULK INGREDIENT 1.

Dosage form	NDCs
tablet, film coated	37
tablet	8
solution	7
tablet, delayed release	3
kit	2
tablet, coated	2
capsule, liquid filled	1
powder	1
powder, for solution	1
tablet, chewable	1

Route	NDCs
oral	60

Labeller name on the listing	NDCs
l.n.k. international, inc.	63

Catalogue

Marketed products

Showing 63 of 64.

Brand	Generic name	Form / route	NDC
Acetaminophen and Ibuprofen	Acetaminophen, Ibuprofen	tablet, film coated, oral	50844-598ANDA
Alert Alertness Aid	Caffeine	tablet, oral	50844-226OTC MONOGRAPH DRUG
Allergy Multi-Symptom	Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl	tablet, film coated, oral	50844-455OTC MONOGRAPH DRUG
Allergy Relief	Diphenhydramine HCl	tablet, film coated, oral	50844-229OTC MONOGRAPH DRUG
Allergy Relief	Diphenhydramine HCl	tablet, film coated, oral	50844-329OTC MONOGRAPH DRUG
Allergy Relief Childrens	Diphenhydramine HCl	solution, oral	50844-015OTC MONOGRAPH DRUG
Anti-Diarrheal	Loperamide HCl	tablet, oral	50844-259ANDA
Anti-diarrheal	Loperamide HCl	tablet, oral	50844-375ANDA
Aspi-Cor	Aspirin	tablet, delayed release, oral	50844-675OTC MONOGRAPH DRUG
Aspirin	Aspirin	tablet, film coated, oral	50844-157OTC MONOGRAPH DRUG
Aspirin Low Dose	Aspirin	tablet, chewable, oral	50844-218OTC MONOGRAPH DRUG
Aspirin Low Dose	Aspirin	tablet, delayed release, oral	50844-600OTC MONOGRAPH DRUG
Back and Body Extra Strength	Aspirin, Caffeine	tablet, film coated, oral	50844-413OTC MONOGRAPH DRUG
Coated Aspirin	Aspirin	tablet, film coated, oral	50844-254OTC MONOGRAPH DRUG
Cold Relief Multi-Symptom	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl	kit	50844-529OTC MONOGRAPH DRUG
Cold and Flu Daytime Relief	Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl	solution, oral	50844-251OTC MONOGRAPH DRUG
Cold and Flu Daytime Severe	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl	tablet, film coated, oral	50844-640OTC MONOGRAPH DRUG
Cold and Flu Nighttime Relief	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate	solution, oral	50844-252OTC MONOGRAPH DRUG
Cold and Flu Nighttime Severe	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl	tablet, film coated, oral	50844-677OTC MONOGRAPH DRUG
Cold and Flu Severe, Day, Night	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr. Guaifenesin, Phenylephrine HCl	kit	50844-547OTC MONOGRAPH DRUG
Cough and Cold HBP	Chlorpheniramine maleate, Dextromethorphan HBr	tablet, film coated, oral	50844-689OTC MONOGRAPH DRUG
Gentle Laxative	Bisacodyl	tablet, delayed release, oral	50844-327OTC MONOGRAPH DRUG
Headache Relief	Acetaminophen, Aspirin, Caffeine	tablet, film coated, oral	50844-258OTC MONOGRAPH DRUG
Ibuprofen	Ibuprofen	tablet, film coated, oral	50844-257ANDA
Ibuprofen	ibuprofen	tablet, film coated, oral	50844-291ANDA
Ibuprofen	ibuprofen	tablet, film coated, oral	50844-292ANDA
Ibuprofen	ibuprofen	tablet, film coated, oral	50844-352ANDA
Ibuprofen	ibuprofen	tablet, film coated, oral	50844-353ANDA
Ibuprofen	ibuprofen	tablet, film coated, oral	50844-392ANDA
Ibuprofen	ibuprofen	tablet, film coated, oral	50844-393ANDA
Ibuprofen	ibuprofen	tablet, film coated, oral	50844-438ANDA
Ibuprofen	Ibuprofen	capsule, liquid filled, oral	50844-754ANDA
-	Ibuprofen	powder	50844-991BULK INGREDIENT
Laxative	Sennosides	tablet, film coated, oral	50844-773OTC MONOGRAPH DRUG
Loperamide HCl	Loperamide HCl	tablet, oral	50844-735ANDA
Menstrual Complete	Acetaminophen, Caffeine, Pyrilamine maleate	tablet, film coated, oral	50844-399OTC MONOGRAPH DRUG
Menstrual Complete Maximum Strength	Acetaminophen, Caffeine and Pyrilamine maleate	tablet, film coated, oral	50844-390OTC MONOGRAPH DRUG
Menstrual Relief Maximum Strength	Acetaminophen, Pamabrom, Pyrilamine maleate	tablet, film coated, oral	50844-679OTC MONOGRAPH DRUG
Motion Sickness Relief	Dimenhydrinate	tablet, oral	50844-199OTC MONOGRAPH DRUG
Motion Sickness Relief	Meclizine HCl	tablet, oral	50844-403OTC MONOGRAPH DRUG
Mucus Relief DM Cough	Dextromethorphan HBr and Guaifenesin	tablet, film coated, oral	50844-633OTC MONOGRAPH DRUG
Naproxen	Naproxen Sodium	tablet, film coated, oral	50844-261ANDA
Naproxen Back and Muscle Pain	Naproxen Sodium	tablet, film coated, oral	50844-714ANDA
Naproxen Headache Pain	Naproxen Sodium	tablet, film coated, oral	50844-471ANDA
Naproxen Sodium	Naproxen Sodium	tablet, film coated, oral	50844-417ANDA
Naproxen Sodium	Naproxen Sodium	tablet, film coated, oral	50844-604ANDA
Nasal Decongestant	Pseudoephedrine HCl	tablet, film coated, oral	50844-112OTC MONOGRAPH DRUG
Nighttime Cough DM	Dextromethorphan HBr, Doxylamine Succinate	solution, oral	50844-043OTC MONOGRAPH DRUG
Nighttime Sleep Aid	Diphenhydramine HCl	solution, oral	50844-200OTC MONOGRAPH DRUG
Nighttime Sleep Aid	Diphenhydramine HCl	solution, oral	50844-250OTC MONOGRAPH DRUG
Nighttime Sleep Aid	Doxylamine succinate	tablet, oral	50844-260ANDA
Nighttime Sleep Aid	Doxylamine succinate	tablet, oral	50844-386ANDA
Pain Reliever	Acetaminophen	tablet, film coated, oral	50844-255OTC MONOGRAPH DRUG
Pain Reliever Extra Strength	Acetaminophen	tablet, film coated, oral	50844-175OTC MONOGRAPH DRUG
Pain Reliever Extra Strength	Acetaminophen	tablet, coated, oral	50844-519OTC MONOGRAPH DRUG
Pain Reliever PM	Acetaminophen, Diphenhydramine HCl	tablet, film coated, oral	50844-256OTC MONOGRAPH DRUG
Pain Reliever PM Extra Strength	Acetaminophen, Diphenhydramine HCl	tablet, film coated, oral	50844-235OTC MONOGRAPH DRUG
Pain Reliever PM Extra Strength	Acetaminophen, Diphenhydramine HCl	tablet, coated, oral	50844-556OTC MONOGRAPH DRUG
Polyethylene Glycol 3350	Polyethylene Glycol 3350	powder, for solution, oral	50844-772ANDA
Severe Congestion and Cough Relief Maximum Strength	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl	solution, oral	50844-004OTC MONOGRAPH DRUG
Sinus Congestion	Phenylephrine HCl	tablet, film coated, oral	50844-493OTC MONOGRAPH DRUG
Sinus Severe	Acetaminophen, Guaifenesin, Phenylephrine HCl	tablet, film coated, oral	50844-572OTC MONOGRAPH DRUG
Sinus and Headache Daytime	Acetaminophen, Phenylephrine HCl	tablet, film coated, oral	50844-467OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

InvaGen Pharmaceuticals, IncCentral Islip, NY
Ascent Pharmaceuticals IncCentral Islip, NY

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Enquiry

Common questions

Is LNK International, Inc. FDA approved?: LNK International, 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 LNK International, Inc.'s drugs manufactured?: The FDA register lists Central Islip, NY. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does LNK International, Inc. make?: 64 products are listed under LNK International, Inc. in the openFDA NDC Directory, most often as tablet, film coated; tablet; solution. 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.