Is AptaPharma Inc. FDA approved?

AptaPharma 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 AptaPharma Inc.'s drugs manufactured?

The FDA register lists Pennsauken, NJ. Registered operations: finished drug manufacture, relabelling, repackaging.

What drugs does AptaPharma Inc. make?

30 products are listed under AptaPharma Inc. in the openFDA NDC Directory, most often as liquid; suspension; capsule, liquid filled. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

AptaPharma Inc.

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

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Registered sites: 1
Active NDC listings: 30
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Finished drug manufacture1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
AptaPharma Inc.	1533 Union Avenue, Pennsauken, New Jersey (NJ) 08110, United States (USA)	Finished drug manufacture, Relabelling, Repackaging	3010164738790523323

Catalogue

Drug listings by form and route

30 active NDC listings: 29 human otc drug, 1 human prescription drug. By marketing category: OTC MONOGRAPH DRUG 26, ANDA 3, NDA 1.

Dosage form	NDCs
liquid	18
suspension	7
capsule, liquid filled	4
solution	1

Route	NDCs
oral	30

Labeller name on the listing	NDCs
aptapharma inc.	29
aptapharma, inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Bismuth Subsalicylate Suspension Regular Strength	BISMUTH SUBSALICYLATE	suspension, oral	76281-557OTC MONOGRAPH DRUG
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCL	liquid, oral	76281-519OTC MONOGRAPH DRUG
CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	liquid, oral	76281-512OTC MONOGRAPH DRUG
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	liquid, oral	76281-505OTC MONOGRAPH DRUG
Childrens Ibuprofen Grape	IBUPROFEN	suspension, oral	76281-126ANDA
Childrens Ibuprofen Oral Suspension	IBUPROFEN	suspension, oral	76281-119ANDA
Childrens Ibuprofen Oral Suspension Dye free	IBUPROFEN	suspension, oral	76281-128ANDA
Childrens Pain and Fever	ACETAMINOPHEN	suspension, oral	76281-525OTC MONOGRAPH DRUG
Childrens Pain and Fever	ACETAMINOPHEN	suspension, oral	76281-526OTC MONOGRAPH DRUG
Day-Time Cold/Flu Relief	Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl	liquid, oral	76281-506OTC MONOGRAPH DRUG
DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels	Acetaminophen,Dextromethrophan HBR	capsule, liquid filled, oral	76281-609OTC MONOGRAPH DRUG
Daytime Cold and Flu Relief Liquid Filled Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl	capsule, liquid filled, oral	76281-604OTC MONOGRAPH DRUG
Maximum Strength Tussin DM Liquid filled Softgels	DEXTROMETHORPHAN HBr, GUAIFENESIN	capsule, liquid filled, oral	76281-601OTC MONOGRAPH DRUG
Maximum strength Max Cold and Sinus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCl	liquid, oral	76281-515OTC MONOGRAPH DRUG
Night Time Cold and Flu relief liquid filled softgels	Acetaminophen,Dextromethrophan HBR,Doxylamine Succinate	capsule, liquid filled, oral	76281-603OTC MONOGRAPH DRUG
Nighttime Sleep-Aid Non-Habit Forming	Diphenhydramine HCI	liquid, oral	76281-522OTC MONOGRAPH DRUG
Nite-Time COLD/FLU Medicine	ACETAMINOPHEN	liquid, oral	76281-501OTC MONOGRAPH DRUG
Nite-Time COLD/FLU Medicine Cherry	ACETAMINOPHEN	liquid, oral	76281-502OTC MONOGRAPH DRUG
PREXXARTAN	PREXXARTAN	solution, oral	76281-155NDA
SEVERE CONGESTION and COUGH MAX	Dextromethorphan HBr, GUaifenesin, Phenylephrine HCL	liquid, oral	76281-517OTC MONOGRAPH DRUG
Stomach Relief - Maximum Strength	BISMUTH SUBSALICYLATE	liquid, oral	76281-538OTC MONOGRAPH DRUG
Stomach Relief - Regular Strength	BISMUTH SUBSALICYLATE	liquid, oral	76281-537OTC MONOGRAPH DRUG
Stomach Relief, Maximum Strength	BISMUTH SUBSALICYLATE	suspension, oral	76281-558OTC MONOGRAPH DRUG
TUSSIN CF	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	liquid, oral	76281-504OTC MONOGRAPH DRUG
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE	liquid, oral	76281-503OTC MONOGRAPH DRUG
Tussin Expectorant	GUAIFENESIN	liquid, oral	76281-507OTC MONOGRAPH DRUG
XL-3 Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	liquid, oral	76281-304OTC MONOGRAPH DRUG
XL-3 Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	liquid, oral	76281-306OTC MONOGRAPH DRUG
XL-3 Xtreme	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate	liquid, oral	76281-305OTC MONOGRAPH DRUG
XL-3 Xtreme	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate	liquid, oral	76281-307OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Cetylite Industries, Inc.Pennsauken, NJ

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Enquiry

Common questions

Is AptaPharma Inc. FDA approved?: AptaPharma 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 AptaPharma Inc.'s drugs manufactured?: The FDA register lists Pennsauken, NJ. Registered operations: finished drug manufacture, relabelling, repackaging.
What drugs does AptaPharma Inc. make?: 30 products are listed under AptaPharma Inc. in the openFDA NDC Directory, most often as liquid; suspension; capsule, liquid filled. 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.