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Active ingredient

Phenylephrine

202 finished FDA listings contain Phenylephrine as their only active ingredient; 1,396 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
PHENYLEPHRINE, PHENYLEPHRINE BITARTRATE, PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, (+/-)-
Dosage forms
Injectable, Liposomal, Injection, Injection, Solution, Solution, Solution/ Drops, Spray, Suppository, Tablet, Tablet, Film Coated
Routes
Intravenous, Nasal, Ophthalmic, Oral, Rectal
Manufacturers / labelers
99
Strengths listed
.1 mg/ml · .25 g/100ml · .5 g/100ml · 1 g/100ml · 10 mg/1 · 10 mg/ml · 100 mg/10ml · 100 mg/ml · 100 ug/ml · 2.5 mg/5ml · 25 mg/1 · 25 mg/ml · 5 mg/1 · 5 mg/2g · 50 mg/5ml · 6.25 mg/1 · 80 ug/ml
Brand names in FDA listings
4 Way Fast Acting, Basic Care Nasal, Better Living, Biorphen, Bliss Gvs Hemorrhoidal, Careone Fast Acting Nasal, Childrens Sudafed Pe Nasal Decongestant, Crane Safety Sinus Decongestant, Cvs Health Four Actions Nasal Decongestant, Decongestant Pe Non Drowsy, Dg Health Nasal Four, Dollar General, Dover Sudanyl Pe, Ephrine Nose Drops, Equaline Nasal, Equate Nasal, Extra Strength Nasal, Extra Strength Sinus Relief Nasal Decongestant, Gencare-Nasal Decongestant Pe, Good Neighbor Pharmacy Nasal Four, Good Sense Nasal Decongestant Pe, Good Sense Nasal Four, Goodmeds Nasal Decongestant, Goodmeds Non-Drowsy Nasal Decongestant Pe, Green Guard Allergy 2 Relief, Heb Nasal, Immphentiv, Mckesson Phenylephrine Hcl, Medi-First Plus Sinus Decongestant, Medi-First Sinus Decongestant, Medique Medi-Phenyl, Nasal, Nasal And Sinus Decongestant, Nasal Decongestant Pe, Nasal Decongestant Pe 10mg, Nasal Decongestant Pe Maximum Strength, Nasal Decongestant Pe Maximum Strength Non-Drowsy, Nasal Decongestant Pe Non-Drowsy Maximum Strength, Nasal Four, Neo-Synephrine Maximum, Neo-Synephrine Mild, Neo-Synephrine Regular, Neo-Synephrine Severe, No Drip Nasal, Pe Sinus Congestion, Phenylephrine Hcl Maximum Strength, Phenylephrine Hemorrhoidal, Phenylephrine Hydrochloride Phenylephrine Hydrochloride, Physicianscare Sinus Non-Drowsy, Preparation H, Pseudo Time Pe, Publix, Quality Choice, Revivol-Xr, Sinus Congestion, Sinus Decongestion Pe, Sinus Pressure And Congestion Relief Pe Maximum Strength, Su Phedrine Pe Non-Drowsy, Maximum Strength, Su Phedrine Pe Sinus Congestion, Sudafed Pe Sinus Congestion, Suphedrine Pe Sinus Congestion Non-Drowsy, Topcare Nasal Four, Unishield Sinus Decongestant, Up And Up, Valumeds Nasal Decongestant Pe Phenylephrine, Valumeds Nasal Decongestant Phenylephrine Hcl

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 8163

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 203826HIKMA2012-12-2010
NDA 203510PARAGON BIOTECK2013-03-214
NDA 207926ALCON2015-01-152
ANDA 210333MEITHEAL2018-04-271
ANDA 210334MEITHEAL2018-04-272
ANDA 211079AMNEAL2018-07-054
ANDA 211078AMNEAL2018-07-192
ANDA 210025PH HEALTH2018-12-212
ANDA 210665FRESENIUS KABI USA2019-01-294
ANDA 210666FRESENIUS KABI USA2019-01-301
ANDA 208905SANDOZ2019-01-316
NDA 212909DR REDDYS LABS SA2019-10-212
ANDA 209967SAGENT PHARMS INC2020-01-161
ANDA 211920GLAND2020-06-053
ANDA 213318CAPLIN2020-06-1117
ANDA 211081MILLA PHARMS2020-07-174
ANDA 210697EUGIA PHARMA2020-11-132
ANDA 210696EUGIA PHARMA2021-01-072
ANDA 217069MANKIND PHARMA2022-08-304
ANDA 216859MANKIND PHARMA2022-09-295
ANDA 216496MANKIND PHARMA2023-01-113
ANDA 209968AVET LIFESCIENCES2023-02-281
ANDA 217521BE PHARMS2023-06-266
ANDA 218412HAINAN POLY2024-03-146
ANDA 218110ASPIRO2024-05-103
ANDA 215183CAPLIN2024-05-237
ANDA 218129GLAND2024-12-186
ANDA 215617SOMERSET THERAPS LLC2025-02-141
NDA 216830DR REDDYS LABS SA2025-05-301
ANDA 217032BAXTER HLTHCARE CORP2026-04-033

Official labeling on DailyMed

Showing the 12 most recent of 140 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.