Is Poly Pharmaceuticals, Inc. FDA approved?

Poly Pharmaceuticals, 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 Poly Pharmaceuticals, Inc.'s registered sites?

The FDA register lists Owens Cross Roads, AL. Registered operations: labelling.

What drugs does Poly Pharmaceuticals, Inc. make?

18 products are listed under Poly Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet; liquid; syrup. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Poly Pharmaceuticals, Inc.

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

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Registered sites: 1
Active NDC listings: 18
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Poly Pharmaceuticals, Inc.	2720 Cullom Blvd Se, Owens Cross Roads, Alabama (AL) 35763-9309, United States (USA)	Labelling	1030589198449894

Catalogue

Drug listings by form and route

18 active NDC listings: 16 human otc drug, 2 human prescription drug. By marketing category: OTC MONOGRAPH DRUG 16, ANDA 2.

Dosage form	NDCs
tablet	10
liquid	5
syrup	1
tablet, film coated	1
tablet, multilayer	1

Route	NDCs
oral	18

Labeller name on the listing	NDCs
poly pharmaceuticals, inc.	17
poly pharmaceuticals, inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ALA-HIST IR	Dexbrompheniramine Maleate	tablet, oral	50991-783OTC MONOGRAPH DRUG
ALAHIST DM	Dextromethorphan HBr, Pheniramine Maleate, Phenylephrine HCl	liquid, oral	50991-444OTC MONOGRAPH DRUG
Alahist D	Pheniramine Maleate, Phenylephrine HCl	tablet, oral	50991-776OTC MONOGRAPH DRUG
Alahist PE	Dexbrompheniramine Maleate, Phenylephrine Hydrochloride	tablet, oral	50991-788OTC MONOGRAPH DRUG
DECONEX DMX	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride	tablet, oral	50991-740OTC MONOGRAPH DRUG
DURATUSS DM	Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide and Pseudoephedrine Hydrochloride	liquid, oral	50991-142OTC MONOGRAPH DRUG
Deconex IR	Guaifenesin and Phenylephrine HCl	tablet, oral	50991-736OTC MONOGRAPH DRUG
Duraflu	ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl	tablet, oral	50991-535OTC MONOGRAPH DRUG
Durahist	Dexbrompheniramine Maleate, Pseudoephedrine HCL	tablet, oral	50991-865OTC MONOGRAPH DRUG
Duratuss AC	Codeine Phosphate, Dexbrompheniramine Maleate	liquid, oral	50991-540OTC MONOGRAPH DRUG
Endal	Triprolidine HCl, Dextromethorphan HBr	liquid, oral	50991-136OTC MONOGRAPH DRUG
Norgesic Forte	Orphenadrine Citrate, Aspirin and Caffeine	tablet, multilayer, oral	50991-999ANDA
POLY-HIST DM	DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR	liquid, oral	50991-271OTC MONOGRAPH DRUG
Poly Hist Forte	Doxylamine Succinate and Phenylephrine Hydrochloride	tablet, oral	50991-626OTC MONOGRAPH DRUG
Poly-Vent DM	Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HCl	tablet, oral	50991-214OTC MONOGRAPH DRUG
Poly-Vent IR	Guaifenesin and Pseudoephedrine HCl	tablet, oral	50991-212OTC MONOGRAPH DRUG
Polytussin DM	Dextromethorphan HBr, Phenylephrine HCl, Pyrilamine Maleate	syrup, oral	50991-132OTC MONOGRAPH DRUG
Tolectin	tolmetin sodium	tablet, film coated, oral	50991-988ANDA

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Enquiry

Common questions

Is Poly Pharmaceuticals, Inc. FDA approved?: Poly Pharmaceuticals, 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 Poly Pharmaceuticals, Inc.'s registered sites?: The FDA register lists Owens Cross Roads, AL. Registered operations: labelling.
What drugs does Poly Pharmaceuticals, Inc. make?: 18 products are listed under Poly Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet; liquid; syrup. 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.