Over-the-counter medicine
Pseudoephedrine First approved as Novafed
Pseudoephedrine (Novafed) is an over-the-counter medicine with an FDA approval on record since 1975. FDA's NDC Directory lists it from 34 generic labelers, and pharmacies paid $0.281 per pseudoephedrine ER 120 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the pseudoephedrine FDA label on DailyMed (effective October 30, 2025, L. Perrigo Company); the NDA 17603 record on Drugs@FDA; every pseudoephedrine label on DailyMed.
Highlights of the record
FDA label of October 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetemporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves sinus congestion and pressure
Forms and strengths
- 120 mg
- 240 mg
Film-coated extended-release tablet; extended-release tablet; film-coated tablet; tablet.
On the market
- Earliest approval on file
- August 29, 1975 Novafed, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first October 31, 1991; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 34 of which 34 under generic applications, 0 under brand applications, repackagers included; 9 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.281 per tablet Pseudoephedrine ER 120 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest May 21, 2019
- FAERS reports
- 11,123 through July 30, 2026
What is pseudoephedrine used for?
From the label: indications and usagetemporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves sinus congestion and pressure
Conditions named in the indications of pseudoephedrine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: alpha-Adrenergic Agonist.
Source: FDA drug label (Good Sense Suphedrine 12 Hour), L. Perrigo Company, effective October 30, 2025 (SPL set 1de8a7f6-e7bb-437d-8794-c4b9f43b89c9), via openFDA; the full label on DailyMed
Is there a generic for pseudoephedrine (Novafed)?
The FDA approved the first generic pseudoephedrine on October 31, 1991. 5 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists pseudoephedrine from 34 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1975 earliest approval on file
- 1991 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pseudoephedrine (Novafed)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.281 per Pseudoephedrine ER 120 mg tablet, up 5% from $0.268 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Pseudoephedrine ER 120 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| 12hr nasal decongest ER 120 mg | Generic | $0.281 per unit | n/a | +5% |
| Ft nasal decongest 30 mg tablet | Generic | $0.0776 per tablet | $2.33 | +26% |
| Ft nasal decongest ER 120 mg | Generic | $0.281 per unit | n/a | +5% |
| Gnp nasal decongest 30 mg tablet | Generic | $0.0776 per tablet | $2.33 | +26% |
| Gnp nasal decongest ER 120 mg | Generic | $0.281 per unit | n/a | +5% |
| Gs nasal decongest 30 mg tablet | Generic | $0.0776 per tablet | $2.33 | +26% |
| Gs suphedrine 12hr 120 mg cplt | Generic | $0.281 per unit | n/a | +5% |
| Nasal decongestant 30 mg tablet | Generic | $0.0776 per tablet | $2.33 | +26% |
| Pseudoephedrine 30 mg tablet | Generic | $0.0776 per tablet | $2.33 | +26% |
| Pseudoephedrine 60 mg tablet | Generic | $0.0775 per tablet | $2.32 | +35% |
| Pseudoephedrine ER 120 mg tablet | Generic | $0.281 per tablet | $8.43 | +5% |
| Sinus 12 hour 120 mg caplet | Generic | $0.281 per unit | n/a | n/a |
| Sm nasal decongest ER 120 mg | Generic | $0.281 per unit | n/a | +5% |
| Sudogest 12 hour 120 mg caplet | Generic | $0.281 per unit | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pseudoephedrine been recalled?
The FDA's Enforcement Report lists 3 recalls naming pseudoephedrine since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 21, 2019 | Class II | Torrent Pharma Inc | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 30 mg may be potentially mislabeled as D-ALPHA TOCOPHERYL ACETATE, Capsule, 400 units, NDC 49348041010 … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W002855, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pseudoephedrine label say about other medicines?
The pseudoephedrine label names no other medicine on this site. The labels of 9 other medicines name pseudoephedrine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name pseudoephedrine
Source: FDA drug label (Good Sense Suphedrine 12 Hour), L. Perrigo Company, effective October 30, 2025 (SPL set 1de8a7f6-e7bb-437d-8794-c4b9f43b89c9), via openFDA; the full label on DailyMed
What do FAERS reports show for pseudoephedrine?
The FDA Adverse Event Reporting System holds 11,123 reports that list pseudoephedrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,854 are coded as a death and 4,401 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2024 (1,970, against a median of 652 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pseudoephedrine?
13 other medicines are given the same way (oral) and in the same FDA class as pseudoephedrine or labeled mainly for the same use (cough and cold), the same class first. Cough and cold lists all 31 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Diphenhydramine | Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Dextromethorphan and guaifenesin | Cough and cold | 61 labelers | $0.0207 per mL 200-20 mg/20 mL | No current entry |
| Guaifenesin | Cough and cold | 102 labelers | $0.284 per tablet 600 mg tablet | No current entry |
| Benzonatate | Cough and cold | 45 labelers | $0.0656 per capsule 100 mg capsule | No current entry |
| Dextromethorphan | Cough and cold | 28 labelers | $0.122 per unit 15 mg softgel | No current entry |
| Phenylephrine | Cough and cold | none listed | $0.0496 per tablet 10 mg tablet | No current entry |
| Dextromethorphan and promethazine | Cough and cold | 13 labelers | $0.039 per mL 6.25-15 mg/5 mL solution | No current entry |
| Homatropine methylbromide and hydrocodone | Cough and cold | 3 labelers | $0.922 per tablet 5-1.5 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does pseudoephedrine compare with medicines for the same use?
5 side-by-side pages set pseudoephedrine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other alpha-adrenergic agonists
- the pharmacologic class, with prices and generics
- Pseudoephedrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other