Is Allegiant Health FDA approved?

Allegiant Health 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 Allegiant Health's drugs manufactured?

The FDA register lists Deer Park, NY. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, repackaging.

What drugs does Allegiant Health make?

113 products are listed under Allegiant Health in the openFDA NDC Directory, most often as tablet; capsule, liquid filled; tablet, coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Allegiant Health

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

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Registered sites: 1
Active NDC listings: 113
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Allegiant Health	75 North Industry Court, Deer Park, New York (NY) 11729, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging, Repackaging	3001195380079501930

Catalogue

Drug listings by form and route

113

113 active NDC listings: 113 human otc drug. By marketing category: OTC MONOGRAPH DRUG 72, ANDA 41.

Dosage form	NDCs
tablet	41
capsule, liquid filled	11
tablet, coated	8
capsule	7
spray, metered	7
tablet, film coated	7
tablet, chewable	6
liquid	5
capsule, coated	4
solution/ drops	3
tablet, extended release	3
tablet, sugar coated	3
kit	2
tablet, delayed release	2
cream	1

Route	NDCs
oral	98
nasal	8
topical	3
ophthalmic	2
auricular (otic)	1
rectal	1

Labeller name on the listing	NDCs
allegiant health	113

Catalogue

Marketed products

113

Brand	Generic name	Form / route	NDC
ASPIRIN Enteric Coated	Aspirin 81 MG	tablet, oral	69168-318OTC MONOGRAPH DRUG
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	spray, metered, nasal	69168-478ANDA
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	spray, metered, nasal	69168-479ANDA
Acetaminophen 325mg RS	Acetaminophen 325mg	tablet, oral	69168-010OTC MONOGRAPH DRUG
Acetaminophen 500mg ES	Acetaminophen 500mg	tablet, oral	69168-011OTC MONOGRAPH DRUG
Acid Reducer	Famotidine	tablet, oral	69168-443ANDA
Acid Reducer	Famotidine	tablet, oral	69168-445ANDA
Allergy	Diphenhydramine HCl	tablet, oral	69168-048OTC MONOGRAPH DRUG
Allergy	Chlorpheniramine maleate	tablet, oral	69168-277OTC MONOGRAPH DRUG
Allergy DyeFree	Allergy DyeFree	capsule, liquid filled, oral	69168-409OTC MONOGRAPH DRUG
Allergy Relief	Loratadine	tablet, oral	69168-309ANDA
Allergy Relief	Cetirizine HCl 10 mg	capsule, liquid filled, oral	69168-392ANDA
Allergy Relief	Cetirizine HCl 10 mg	tablet, oral	69168-396ANDA
Allergy Relief	Fexofenadine HCl	capsule, coated, oral	69168-413ANDA
Allergy Relief	Loratadine	tablet, oral	69168-414ANDA
Allergy Relief	Fexofenadine HCl	capsule, coated, oral	69168-416ANDA
Allergy Relief	Allergy Relief	tablet, oral	69168-450ANDA
Allergy Relief Non Drowsy	Fexofenadine HCl	tablet, film coated, oral	69168-437ANDA
Allery Relief 24HR	Allery Relief 24HR	tablet, film coated, oral	69168-451ANDA
Anti-Diarrheal	Loperamide HCl	tablet, coated, oral	69168-248ANDA
Anti-Gas	Simethicone	capsule, oral	69168-419OTC MONOGRAPH DRUG
Aspirin	Aspirin 325 mg	tablet, oral	69168-312OTC MONOGRAPH DRUG
Aspirin 81mg Dye-Free	Aspirin 81mg	tablet, film coated, oral	69168-457OTC MONOGRAPH DRUG
Aspirin 81mg Enteric coated Delayed Release	Aspirin	tablet, coated, oral	69168-405OTC MONOGRAPH DRUG
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen	Aspirin	tablet, delayed release, oral	69168-006OTC MONOGRAPH DRUG
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen	Aspirin	tablet, coated, oral	69168-430OTC MONOGRAPH DRUG
Aspirin Chewable	Aspirin 81 mg	tablet, oral	69168-288OTC MONOGRAPH DRUG
Aspirin Enteric Coated	Aspirin 81 mg	tablet, oral	69168-372OTC MONOGRAPH DRUG
Bisacodyl 5mg	Bisacodyl 5mg	tablet, coated, oral	69168-398OTC MONOGRAPH DRUG
Bismuth	Bismuth subsalicylate	tablet, oral	69168-046OTC MONOGRAPH DRUG
Calcium Antacid	Calcium Carbonate	tablet, chewable, oral	69168-219OTC MONOGRAPH DRUG
Calcium Antacid	Calcium Carbonate	tablet, chewable, oral	69168-229OTC MONOGRAPH DRUG
Calcium Carbonate	Calcium Carbonate	tablet, chewable, oral	69168-036OTC MONOGRAPH DRUG
Calcium Carbonate	Antacid	tablet, chewable, oral	69168-124OTC MONOGRAPH DRUG
Carbamide peroxide 6.5%	Earwax Removal Kit	solution/ drops, auricular (otic)	69168-488OTC MONOGRAPH DRUG
Children Pain Relief	Children Pain Relief	tablet, chewable, oral	69168-440OTC MONOGRAPH DRUG
Childrens Allergy Relief	Childrens Allergy Relief	liquid, oral	69168-471OTC MONOGRAPH DRUG
Childrens Pain Relief	Childrens Pain Relief	liquid, oral	69168-455OTC MONOGRAPH DRUG
Cold Medicine	Cold Medicine	tablet, oral	69168-004OTC MONOGRAPH DRUG
Cold Multi-Symptom	Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl	tablet, coated, oral	69168-324OTC MONOGRAPH DRUG
Cold Multi-Symptom Night-time	Acetaminophen,Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCI	tablet, oral	69168-319OTC MONOGRAPH DRUG
Cold Therapy Roll on	Cold Therapy Roll on	gel, topical	69168-483OTC MONOGRAPH DRUG
Cold and Allergy	Phenylephrine HCl and Chlorpheniramine maleate	tablet, oral	69168-406OTC MONOGRAPH DRUG
Daytime Cold and Flu	Acetaminophen 325mg/ Dextromethorphan HBr 10mg/ Phenylephrine HCl 5mg	capsule, oral	69168-417OTC MONOGRAPH DRUG
Daytime Cold and Flu	Daytime Cold and Flu	capsule, liquid filled, oral	69168-474OTC MONOGRAPH DRUG
Daytime Nighttime Cold and Flu Relief Combo Pack	Daytime Nighttime Cold and Flu	kit	69168-438OTC MONOGRAPH DRUG
Daytime and Nighttime Cold and Flu Kit	Daytime and Nighttime Cold and Flu Kit	kit	69168-013OTC MONOGRAPH DRUG
Decongestant PE Non Drowsy	Phenylephrine HCl	tablet, oral	69168-271OTC MONOGRAPH DRUG
Diphenhydramine HCl 25mg	Sleep Aid	tablet, coated, oral	69168-002OTC MONOGRAPH DRUG
Dual Action Pain Relief	Dual Action Pain Relief	capsule, oral	69168-462ANDA
Esomeprazole Magnesium	esomeprazole magnesium capsule, delayed release	capsule, oral	69168-472ANDA
Eye Allergy Itch Relief	Eye Allergy Itch Relief	solution/ drops, ophthalmic	69168-495ANDA
Fluticasone Propionate	Fluticasone Propionate	spray, metered, nasal	69168-014ANDA
Fluticasone Propionate	Fluticasone Propionate	spray, metered, nasal	69168-380ANDA
Fluticasone Propionate	Fluticasone Propionate	spray, metered, nasal	69168-448ANDA
Fluticasone Propionate	Fluticasone propionate	spray, metered, nasal	69168-452ANDA
Gas Relief	Simethicone	capsule, liquid filled, oral	69168-433OTC MONOGRAPH DRUG
Gas Relief	Simethicone	capsule, liquid filled, oral	69168-434OTC MONOGRAPH DRUG
Gastrobiz	Bismuth subsalicylate	tablet, chewable, oral	69168-999OTC MONOGRAPH DRUG
Headache Relief Extra Strength	Acetaminophen, Aspirin and Caffeine	tablet, film coated, oral	69168-285OTC MONOGRAPH DRUG
Ibuprofen	Ibuprofen	tablet, film coated, oral	69168-466ANDA
Ibuprofen 200 mg	Ibuprofen	capsule, liquid filled, oral	69168-368ANDA
Ibuprofen 200mg	Ibuprofen	tablet, oral	69168-381ANDA
Ibuprofen 200mg	Ibuprofen 200mg	tablet, oral	69168-382ANDA
Ibuprofen 200mg	Ibuprofen 200mg	tablet, film coated, oral	69168-390ANDA
Ibuprofen 200mg	Ibuprofen 200mg	tablet, oral	69168-467ANDA
Ibuprofen Fast relief medicine for pain	Ibuprofen 200 mg	tablet, oral	69168-335ANDA
Laxative	Laxative	tablet, sugar coated, oral	69168-489OTC MONOGRAPH DRUG
Laxative Enteric Coated	Bisacodyl 5mg	tablet, sugar coated, oral	69168-404OTC MONOGRAPH DRUG
Lidocaine Pain Relief	Lidocaine Pain Relief	patch, topical	69168-481OTC MONOGRAPH DRUG
Loratadine 10mg	Loratadine 10mg	tablet, oral	69168-475ANDA
MENSTRUAL COMPLETE	Menstrual Complete	tablet, film coated, oral	69168-470OTC MONOGRAPH DRUG
Magnesium Oxide 400mg	Magnesium Oxide 400mg	tablet, oral	69168-174OTC MONOGRAPH DRUG
Motion Sickness Relief	Dimenhydrinate 50mg	tablet, oral	69168-408OTC MONOGRAPH DRUG
Mucus Relief	Mucus Relief	tablet, extended release, oral	69168-459ANDA
Mucus Relief DM Immediate Release	Mucus Relief DM	tablet, oral	69168-432OTC MONOGRAPH DRUG
Mucus Relief Immediate Release	GUAIFENESIN	tablet, oral	69168-370OTC MONOGRAPH DRUG
Mucus Relief Immediate Release	Mucus Relief	tablet, oral	69168-916OTC MONOGRAPH DRUG
Mucus Relief Maximum Strength	Mucus Relief	tablet, extended release, oral	69168-460ANDA
Naproxen Caplets	Naproxen Sodium 220 mg	tablet, oral	69168-394ANDA
Naproxen Caplets All day relief for pain	Naproxen Sodium 220 mg	tablet, oral	69168-362ANDA
Naproxen Sodium 220mg	Naproxen Sodium 220mg	tablet, coated, oral	69168-395ANDA
Nasal Decongestant PE Maximum Strength Non-Drowsy	Phenylephrine 10 mg	tablet, oral	69168-272OTC MONOGRAPH DRUG
Nighttime Cold and Flu Relief	Acetaminophen	capsule, oral	69168-418OTC MONOGRAPH DRUG
Nighttime Sleep Aid	Nighttime Sleep Aid	tablet, oral	69168-439ANDA
Nighttime Sleep Aid	Nighttime Sleep Aid	liquid, oral	69168-446OTC MONOGRAPH DRUG
Nighttime Sleep Aid	Nighttime Sleep Aid	liquid, oral	69168-486OTC MONOGRAPH DRUG
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	solution/ drops, ophthalmic	69168-480ANDA
Omeprazole	Omeprazole	tablet, delayed release, oral	69168-476ANDA
Pain Relief	Pain Relief	tablet, extended release, oral	69168-461ANDA
Pain Relief Extra Strength	Pain Relief	tablet, oral	69168-005OTC MONOGRAPH DRUG
Pain Relief Extra Strength	Acetaminophen 500 mg	tablet, oral	69168-328OTC MONOGRAPH DRUG
Pain Relief Extra Strength	Acetaminophen 500mg	capsule, coated, oral	69168-426OTC MONOGRAPH DRUG
Pain Relief PM Extra Strength	Pain Relief PM	tablet, oral	69168-003OTC MONOGRAPH DRUG
Pain Relief PM Extra Strength	Acetaminophen 500 mg and Diphenhydramine HCl 25 mg	tablet, oral	69168-393OTC MONOGRAPH DRUG
Polyethylene Gycol 3350	Polyethylene Gycol 3350	powder, for solution, oral	69168-473ANDA
Rectal Care Cream	Rectal Care Cream	cream, rectal, topical	69168-484OTC MONOGRAPH DRUG
Senna Lax	Sennosides 8.6mg	tablet, oral	69168-371OTC MONOGRAPH DRUG
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy	Acetaminophen and Phenylephrine HCl	tablet, oral	69168-270OTC MONOGRAPH DRUG
Sleep Aid	Diphenhydramine HCl 25 mg	tablet, oral	69168-263OTC MONOGRAPH DRUG
Sleep Aid	Diphenhydramine HCl	capsule, liquid filled, oral	69168-410OTC MONOGRAPH DRUG
Sleep Aid	Diphenhydramine HCl	capsule, liquid filled, oral	69168-431OTC MONOGRAPH DRUG
Sleep Aid	Sleep Aid	capsule, liquid filled, oral	69168-917OTC MONOGRAPH DRUG
Sleep Tabs For Nighttime use	Diphenhydramine HCl Tablets	tablet, oral	69168-247OTC MONOGRAPH DRUG
Sound Body Ibuprofen	Ibuprofen 200 mg	capsule, liquid filled, oral	69168-914ANDA
Stay Awake	Caffeine	tablet, coated, oral	69168-076OTC MONOGRAPH DRUG
Stool Softener	Docusate Sodium	capsule, oral	69168-420OTC MONOGRAPH DRUG
Stool Softener	Docusate Sodium	capsule, liquid filled, oral	69168-424OTC MONOGRAPH DRUG
Tension Headache Relief	Tension Headache Relief	capsule, coated, oral	69168-001OTC MONOGRAPH DRUG
Tension Headache Relief	Tension Headache Relief	capsule, oral	69168-029OTC MONOGRAPH DRUG
Triamcinolone acetonide	Triamcinolone acetonide	spray, metered, nasal, nasal	69168-482ANDA
Tussin DM	Tussin DM	liquid, oral	69168-477OTC MONOGRAPH DRUG
Womens Laxative	Womens Laxtive	tablet, sugar coated, oral	69168-490OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is Allegiant Health FDA approved?: Allegiant Health 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 Allegiant Health's drugs manufactured?: The FDA register lists Deer Park, NY. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, repackaging.
What drugs does Allegiant Health make?: 113 products are listed under Allegiant Health in the openFDA NDC Directory, most often as tablet; capsule, liquid filled; tablet, coated. 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.