Is Guardian Drug Company, Inc. FDA approved?

Guardian Drug Company, 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 Guardian Drug Company, Inc.'s drugs manufactured?

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

What drugs does Guardian Drug Company, Inc. make?

46 products are listed under Guardian Drug Company, Inc. in the openFDA NDC Directory, most often as liquid; tablet, chewable; suspension/ drops. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Guardian Drug Company, Inc.

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

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Registered sites: 1
Active NDC listings: 46
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Guardian Drug Company, Inc.	2 Charles Court, Dayton, New Jersey (NJ) 08810, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	2245306119210276

Catalogue

Drug listings by form and route

46 active NDC listings: 38 human otc drug, 8 human prescription drug. By marketing category: OTC MONOGRAPH DRUG 26, ANDA 20.

Dosage form	NDCs
liquid	12
tablet, chewable	12
suspension/ drops	6
solution	5
tablet, extended release	4
capsule	2
tablet	2
capsule, delayed release	1
powder, for solution	1
tablet, film coated	1

Route	NDCs
oral	46
rectal	2

Labeller name on the listing	NDCs
guardian drug company	46

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Alkums antacid	calcium carbonate	tablet, chewable, oral	53041-126OTC MONOGRAPH DRUG
Antacid	aluminum hydroxide, magnesium hydroxide, simethicone	liquid, oral	53041-509OTC MONOGRAPH DRUG
Childrens Ibuprofen	Ibuprofen	suspension/ drops, oral	53041-634ANDA
Childrens Ibuprofen blue raspberry	Ibuprofen	suspension/ drops, oral	53041-638ANDA
Childrens Ibuprofen bubblegum	Ibuprofen	suspension/ drops, oral	53041-572ANDA
Childrens Ibuprofen fruit	Ibuprofen	suspension/ drops, oral	53041-632ANDA
Childrens Ibuprofen grape	Ibuprofen	suspension/ drops, oral	53041-639ANDA
Childrens Metapp Daytime	Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl	liquid, oral	53041-577OTC MONOGRAPH DRUG
Childrens Tussnex	Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl	liquid, oral	53041-622OTC MONOGRAPH DRUG
Childrens Tussnex Multi-symptom cold	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl	liquid, oral	53041-615OTC MONOGRAPH DRUG
Concentrated ibuprofen infants	Ibuprofen	suspension/ drops, oral	53041-637ANDA
Diatrizoate Meglumine and Diatrizoate Sodium	Diatrizoate Meglumine and Diatrizoate Sodium	solution, oral, rectal	53041-688ANDA
Diatrizoate Meglumine and Diatrizoate Sodium	Diatrizoate Meglumine and Diatrizoate Sodium	solution, oral, rectal	53041-690ANDA
Esomeprazole Magnesium	esomeprazole magnesium	capsule, delayed release, oral	53041-666ANDA
Fiber Caps	Calcium polycarbophil	tablet, film coated, oral	53041-147OTC MONOGRAPH DRUG
GDC Extra strength Alkums Antacid 127AF	Calcium Carbonate	tablet, chewable, oral	53041-102OTC MONOGRAPH DRUG
Gas relief	Simethicone	tablet, chewable, oral	53041-103OTC MONOGRAPH DRUG
Guaifenesin Extended-Release 1200 mg	Guaifenesin	tablet, extended release, oral	53041-234ANDA
Guaifenesin Extended-Release 600 mg	Guaifenesin	tablet, extended release, oral	53041-233ANDA
Guardian Extra Strength Antacid	Calcium carbonate	tablet, chewable, oral	53041-130OTC MONOGRAPH DRUG
Guardian Extra Strength Assorted Berry Antacid Extra strength Assorted Berry Antacid	Calcium carbonate	tablet, chewable, oral	53041-184OTC MONOGRAPH DRUG
Guardian Extra Strength Smooth Alkum Antacid 173bf	Calcium carbonate	tablet, chewable, oral	53041-717OTC MONOGRAPH DRUG
Guardian Pink Bismuth	Bismuth subsalicylate	tablet, chewable, oral	53041-021OTC MONOGRAPH DRUG
Guardian Pink-Bismuth Cherry	Bismuth subsalicylate	tablet, chewable, oral	53041-022OTC MONOGRAPH DRUG
Guardian Regular Strength Alkums	Calcium carbonate	tablet, chewable, oral	53041-098OTC MONOGRAPH DRUG
Guardian Ultra Strength Antacid Assorted Fruit	Calcium carbonate	tablet, chewable, oral	53041-171OTC MONOGRAPH DRUG
Levetiracetam	Levetiracetam	solution, oral	53041-660ANDA
Loperamide Hydrochloride, Simethicone	Loperamide Hydrochloride, Simethicone	tablet, oral	53041-263ANDA
Maximum Strength Antacid Mint	Simethicone	tablet, chewable, oral	53041-100OTC MONOGRAPH DRUG
Maximum Strength Stomach Relief	Bismuth subsalicylate	liquid, oral	53041-528OTC MONOGRAPH DRUG
Maximum strength Tussnex FM DM Max	Dextromethorphan HBr, Guaifenesin	liquid, oral	53041-628OTC MONOGRAPH DRUG
Mucus Relief 600 mg	Guaifenesin	tablet, extended release, oral	53041-190ANDA
Mucus Relief Maximum Strength 1200 mg	Guaifenesin	tablet, extended release, oral	53041-191ANDA
Nighttime Sleep-Aid	Diphenhydramine HCl	liquid, oral	53041-633OTC MONOGRAPH DRUG
Omeprazole, Sodium bicarbonate	Omeprazole, Sodium bicarbonate	capsule, oral	53041-663ANDA
Omeprazole, Sodium bicarbonate	Omeprazole, Sodium bicarbonate	capsule, oral	53041-664ANDA
Pink-Bismuth	Bismuth Subsalicylate	liquid, oral	53041-527OTC MONOGRAPH DRUG
Potassium Chloride	Potassium Chloride	powder, for solution, oral	53041-420ANDA
Potassium Chloride	Potassium Chloride	solution, oral	53041-680ANDA
Potassium Chloride	Potassium Chloride	solution, oral	53041-681ANDA
Senna-Lax	Sennosides	tablet, oral	53041-159OTC MONOGRAPH DRUG
Tussnex FM Cold and Sinus	Acteaminophen, Guaifenesin, Phenylephrine HCl	liquid, oral	53041-616OTC MONOGRAPH DRUG
Tussnex FM Cold, Flu and Sore Throat	Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl	liquid, oral	53041-618OTC MONOGRAPH DRUG
Tussnex FM Severe cough and congestion	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl	liquid, oral	53041-617OTC MONOGRAPH DRUG
Ultra Strength Antacid Assorted Berries	Calcium carbonate	tablet, chewable, oral	53041-161OTC MONOGRAPH DRUG
Ultra Strength Stomach Relief	Bismuth subsalicylate	liquid, oral	53041-529OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Reliable Healthcare Logistics, LLCDayton, NJ
Aurolife Pharma LLCDayton, NJ
Safrel Pharmaceuticals LLCDayton, NJ

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Enquiry

Common questions

Is Guardian Drug Company, Inc. FDA approved?: Guardian Drug Company, 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 Guardian Drug Company, Inc.'s drugs manufactured?: The FDA register lists Dayton, NJ. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Guardian Drug Company, Inc. make?: 46 products are listed under Guardian Drug Company, Inc. in the openFDA NDC Directory, most often as liquid; tablet, chewable; suspension/ drops. 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.