Active ingredient
Pseudoephedrine
87 finished FDA listings contain Pseudoephedrine as their only active ingredient; 257 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- PSEUDOEPHEDRINE, PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE SULFATE
- Dosage forms
- Capsule, Gelatin Coated, Solution, Tablet, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 44
- Strengths listed
- 120 mg/1 · 15 mg/5ml · 240 mg/1 · 30 mg/1 · 60 mg/1
- Brand names in FDA listings
- 12 Hour Nasal Decongestant, Careone Nasal And Sinus Decongestant, Childrens Sudafed Nasal Decongestant, Equaline 12 Hour Decongestant, Equaline Nasal Decongestant Non Drowsy Maximum Strength, Equate Sinus 12 Hour, Good Neighbor Pharmacy Nasal Decongestant, Good Sense Nasal Decongestant, Good Sense Suphedrine 12 Hour, Leader 12 Hour Nasal Decongestant, Leader 12 Hour Sinus Nasal Decongestant, Leader Nasal Decongestant, Nasal Decongestant, Nasal Decongestant D, Nasal Decongestant Maximum Strength, Nasal Decongestant Maximum Strength Non Drowsy, Nasal Decongestant Maximum Strength, Non-Drowsy, Nasal Decongestant Non-Drowsy, Pseudoephedrine Hydrochloride, Sinus, Sinus 12 Hour, Sinus And Congestion Non-Drowsy, Sinus And Nasal Decongestant, Sinus Congestion, Sinus Decongestion, Sinus Pressure And Congestion Relief Maximum Strength, Sudafed Sinus Congestion, Sudafed Sinus Congestion 12 Hour, Sudogest, Sudogest 12 Hour, Sudogest Nasal Decongestant, Topcare 12 Hour Decongestant, Topcare Nasal Decongestant Maximum Strength Non Drowsy, Zephrex D
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8896
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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 075153 | L PERRIGO CO | 1999-02-26 | 20 |
| ANDA 077442 | SUN PHARM INDS LTD | 2005-09-28 | 20 |
| ANDA 209008 | AUROBINDO PHARMA | 2017-06-09 | 2 |
| ANDA 218854 | AUROBINDO PHARMA LTD | 2025-12-29 | 2 |
Official labeling on DailyMed
- NASAL DECONGESTANT MAXIMUM STRENGTH, NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [AMERISOURCE BERGEN] · version 12 · 2026-08-17
- NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [HYVEE INC] · version 3 · 2026-07-03
- SINUS AND CONGESTION NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] · version 8 · 2026-06-23
- SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [MAJOR PHARMACEUTICALS] · version 6 · 2026-06-03
- NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] · version 3 · 2026-05-13
- PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC] · version 2 · 2026-05-11
- PSEUDOEPHEDRINE HCL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 12 · 2026-04-17
- NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC] · version 5 · 2026-04-03
- CAREONE NASAL AND SINUS DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY] · version 5 · 2026-04-02
- SINUS PRESSURE AND CONGESTION RELIEF MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] · version 23 · 2026-03-12
- LEADER 12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER] · version 4 · 2026-02-27
- SINUS AND NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] · version 3 · 2026-02-25
Showing the 12 most recent of 81 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.