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Data / Drug companies / Phenylephrine hydrochloride

Phenylephrine hydrochloride: 77 companies and 169 products in the FDA NDC directory

Phenylephrine hydrochloride is listed in the FDA National Drug Code Directory by 77 companies, with 169 products in commercial distribution. 96 of the products (56.8%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection; solution/ drops; spray, and the newest product started marketing on September 1, 2026.

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Companies listing it
77
Products
169
Generic (ANDA) products
96 (56.8%)
Application numbers
32
Routes
Intravenous, Nasal, Ophthalmic, Oral, Rectal
Brand names
Nasal Decongestant Pe, Preparation H, Immphentiv, Equate Nasal, Nasal and Sinus Decongestant, Medi-First Plus Sinus Decongestant, Biorphen, Gencare-Nasal Decongestant Pe
openFDA record search
api.fda.gov

Companies that list phenylephrine hydrochloride

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Lifestar Pharma LLC7solution/ drops; injectionGeneric drugs (ANDA)August 26, 2025
Medical Purchasing Solutions, LLC7injectionGeneric drugs (ANDA)March 28, 2023
Somerset Therapeutics, LLC7injection; solutionGeneric drugs (ANDA)March 4, 2025
Caplin Steriles Limited6injection; solution/ dropsGeneric drugs (ANDA)April 28, 2026
Gland Pharma Limited6injection; solution/ dropsGeneric drugs (ANDA)September 17, 2025
Hikma Pharmaceuticals USA Inc.6injection; injectable, liposomalNew drug applications (NDA)March 9, 2023
Sandoz Inc6injectionGeneric drugs (ANDA)February 17, 2021
Unifirst First Aid Corporation5tablet, film coatedOver the counter monograph drugsApril 18, 2019
BF Ascher and Co Inc4sprayOver the counter monograph drugsJune 1, 2026
Amneal Pharmaceuticals LLC3injectionGeneric drugs (ANDA)July 24, 2018
Armas Pharmaceuticals Inc.3injectionGeneric drugs (ANDA)March 28, 2023
Baxter Healthcare Corporation3injectionGeneric drugs (ANDA)April 6, 2026
Be Pharmaceuticals Inc.3injectionGeneric drugs (ANDA)July 10, 2023
Cabinet Health P.B.C.3tabletOver the counter monograph drugsJuly 1, 2026
Camber Pharmaceuticals, Inc.3injectionGeneric drugs (ANDA)May 10, 2024
Dr. Reddy's Laboratories Inc.3solution/ dropsGeneric drugs (ANDA)September 30, 2025
Eugia US LLC3injectionGeneric drugs (ANDA)January 7, 2021
Fresenius Kabi USA, LLC3injectionGeneric drugs (ANDA)May 25, 2019
Hainan Poly Pharm. Co., Ltd.3injectionGeneric drugs (ANDA)March 19, 2024
Method Pharmaceuticals, LLC3injectionGeneric drugs (ANDA)February 1, 2026
Novadoz Pharmaceuticals LLC3injectionGeneric drugs (ANDA)July 10, 2023
Provepharm Inc.3injectionGeneric drugs (ANDA)August 12, 2020
Xellia Pharmaceuticals USA LLC3injectionGeneric drugs (ANDA)January 1, 2022
Alcon Laboratories, Inc.2solution/ dropsNew drug applications (NDA)January 15, 2015
Amazon.com Services LLC2sprayOver the counter monograph drugsJuly 30, 2026
Bausch & Lomb Americas Inc.2solution/ dropsAuthorized generics (NDA)March 31, 2023
CVS Pharmacy2sprayOver the counter monograph drugsSeptember 21, 2020
Civica, Inc.2injectionNew drug applications (NDA)December 2, 2020
Dr. Reddy's Laboratories Inc.2injection, solutionNew drug applications (NDA)November 25, 2022
First Nation Group, LLC2solution/ dropsGeneric drugs (ANDA)September 1, 2026
HHH Pharmaceuticals2tabletOver the counter monograph drugsSeptember 10, 2025
Haleon US Holdings LLC2suppositoryOver the counter monograph drugsApril 30, 2025
JHK Inc DBA American Safety & First Aid2tabletOver the counter monograph drugsFebruary 2, 2000
Kenvue Brands LLC2solution; tablet, film coatedOver the counter monograph drugsJune 17, 2019
Leading Pharma, LLC2solutionGeneric drugs (ANDA)September 5, 2024
Meitheal Pharmaceuticals Inc.2injectionGeneric drugs (ANDA)April 27, 2018
NorthStar RxLLC2solution/ dropsGeneric drugs (ANDA)October 1, 2024
Par Health USA, LLC2injectionGeneric drugs (ANDA)July 17, 2019
Paragon BioTeck, Inc.2solution/ dropsNew drug applications (NDA)April 15, 2013
Pioneer Life Sciences, LLC2tabletOver the counter monograph drugsFebruary 18, 2025
Sola Pharmaceuticals, LLC2solution/ dropsGeneric drugs (ANDA)June 1, 2024
Walgreen Company2solution/ drops; sprayOver the counter monograph drugsJanuary 31, 2022
A-S Medication Solutions1tabletOver the counter monograph drugsJune 21, 2005
Advanced Rx LLC1tabletOver the counter monograph drugsJune 1, 2025
American Sales Company1sprayOver the counter monograph drugsNovember 30, 2016
Amerisource Bergen1sprayOver the counter monograph drugsApril 15, 2021
Bi-Mart1tabletOver the counter monograph drugsMarch 1, 2025
CVS Pharmacy1sprayOver the counter monograph drugsApril 1, 2015
CVS Woonsocket Prescription Center, Incorporated1sprayOver the counter monograph drugsJune 22, 2026
Cardinal Health 107, LLC1injectionGeneric drugs (ANDA)July 7, 2018
Cardinal Health 110, LLC. DBA Leader1sprayOver the counter monograph drugsJune 6, 2017
Chain Drug Marketing Association1solution/ dropsOver the counter monograph drugsDecember 18, 2018
Chain Drug Marketing Association, Inc.1solution/ dropsOver the counter monograph drugsOctober 8, 2024
Dolgencorp, Inc. (dollar General & Rexall)1sprayOver the counter monograph drugsJune 16, 2021
Fresenius Kabi USA, LLC1injectionGeneric drugs (ANDA)May 10, 2026
H E B1sprayOver the counter monograph drugsMarch 14, 2019
HF Acquisition Co LLC, DBA HealthFirst1injectionGeneric drugs (ANDA)June 30, 2021
Haleon US Holdings LLC1sprayOver the counter monograph drugsJanuary 1, 2010
Henry Schein, Inc.1injectionGeneric drugs (ANDA)January 13, 2022
Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc.1injectionGeneric drugs (ANDA)February 28, 2023
HyVee Inc1sprayOver the counter monograph drugsMay 3, 2003
InvaTech Pharma Solutions LLC1tabletOver the counter monograph drugsJanuary 13, 2021
Kroger Company1sprayOver the counter monograph drugsFebruary 18, 2014
L. Perrigo Company1sprayOver the counter monograph drugsAugust 9, 2002
Meijer, Inc.1sprayOver the counter monograph drugsMay 14, 2024
ProPharma Distribution1injectionGeneric drugs (ANDA)August 31, 2022
Publix Super Markets, Inc1sprayOver the counter monograph drugsMay 20, 2019
Safeway1sprayOver the counter monograph drugsApril 17, 2019
Sagent Pharmaceuticals1injection, solutionGeneric drugs (ANDA)October 15, 2020
Sportpharm LLC1tablet, film coatedOver the counter monograph drugsMarch 7, 2026
Target Corporation1suppositoryOver the counter monograph drugsAugust 3, 2026
Thompson1tablet, film coatedOver the counter monograph drugsJanuary 17, 2020
Topco Associates LLC1sprayOver the counter monograph drugsDecember 10, 2002
Unipack, Inc.1suppositoryOver the counter monograph drugsApril 1, 2025
United Natural Foods, Inc. DBA Unfi1sprayOver the counter monograph drugsJuly 26, 2018
Wal-Mart Stores Inc1sprayOver the counter monograph drugsJuly 24, 2002
Walmart Inc.1sprayOver the counter monograph drugsFebruary 4, 2025

Dosage forms

Dosage formProductsShare
Injection8147.9%
Solution/ drops2816.6%
Spray2716%
Tablet137.7%
Tablet, film coated84.7%
Solution42.4%
Suppository42.4%
Injection, solution31.8%
Injectable, liposomal10.6%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)9656.8%
Over the counter monograph drugs5633.1%
New drug applications (NDA)158.9%
Authorized generics (NDA)21.2%

Pharmacologic classes

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.