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novafed

Pharmaranks rates Novafed 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Novafed (Pseudoephedrine Hydrochloride) is an alpha-adrenergic agonist used to treat Asthma, Common Cold, Perennial Allergic Rhinitis, Sinusitis.

Pseudoephedrine Hydrochloride · by Sanofi Aventis US

Available as a generic: Pseudoephedrine Hydrochloride

70/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated August 18, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass
~$8.29 /30
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Key facts

Form
Capsule, extended release
Strength
Pseudoephedrine Hydrochloride 120MG
Type
Prescription (Rx)
Brand or generic
Brand-name
Manufacturer
Sanofi Aventis US
Half-life
roughly 3 to 16 hours — the label does not give one number, because the elimination half-life depends on urine pH: about 3 to 6 hours when urine pH is 5 (acidic), and about 9 to 16 hours when urine pH is 8 (alkaline) (how long it stays in your system)
What the pharmacy pays
~$8.29 for 30 — not your price
FDA application
NDA017603
Availability
Discontinued (per FDA)

How long does Pseudoephedrine Hydrochloride stay in your body?

The elimination half-life of pseudoephedrine hydrochloride is roughly 3 to 16 hours — the label does not give one number, because the elimination half-life depends on urine pH: about 3 to 6 hours when urine pH is 5 (acidic), and about 9 to 16 hours when urine pH is 8 (alkaline) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is a genuinely variable half-life, not a fixed one. Pseudoephedrine is cleared mostly unchanged by the kidneys (55% to 96% of a dose appears unchanged in urine), and because it is a base, acidic urine traps and flushes it out faster while alkaline urine lets it be reabsorbed — hence the 3-6 h vs 9-16 h spread the label reports. No active metabolite to worry about: the label says less than 1% is metabolized in the liver, by N-demethylation, to an INACTIVE metabolite. It is not a prodrug. Kidney impairment: because clearance is renal, the label states pseudoephedrine "may accumulate in patients with renal impairment," and the product is to be generally avoided in these patients — expect a longer half-life, though the label does not quantify it. Liver impairment: no studies of pseudoephedrine were conducted in hepatic impairment, so the label gives no number; the product is likewise to be generally avoided. Older adults: this label gives no separate pseudoephedrine half-life for people 65+ (its geriatric pharmacokinetic data covers the antihistamine component only), but it warns that older adults are more likely to have adverse reactions to sympathomimetic amines. The half-life above is from the Clarinex-D 12 Hour label, which is where FDA-approved pseudoephedrine pharmacokinetics are published; standalone OTC pseudoephedrine products carry monograph "Drug Facts" labels that contain no pharmacokinetics section at all.

This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: CLARINEX-D 12 HOUR (desloratadine and pseudoephedrine sulfate) extended release tablets — Section 12.3 Pharmacokinetics, DailyMed.

Drug class

How this class works, per Alpha-1 Receptor Agonists - StatPearls - NCBI Bookshelf.

May treat (source: NIH RxClass)

Dosage forms

Capsule, extended release

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

Same active ingredient, far cheaper. Is there a generic? →

Request a 90-day supply

Bulk fills usually lower the per-dose price vs monthly refills.

Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

Compare alternatives

A same-class option may cost less. See alternatives →

Frequently asked questions

What does Novafed treat?
Novafed (Pseudoephedrine Hydrochloride) may be used to treat asthma, common cold, perennial allergic rhinitis, sinusitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How does Novafed work?
Novafed is a alpha-adrenergic agonist. Alpha-adrenergic agonists switch on alpha receptors on blood-vessel walls, much like the body's own adrenaline. This tightens the smooth muscle around the vessels, narrowing them to raise blood pressure or reduce swelling and congestion.
How is Novafed rated?
pharmaranks gives Novafed a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
How much does Novafed cost?
Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $8.29 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
Is there a coupon or discount for Novafed?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Novafed. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Novafed?
Novafed is marketed by Sanofi Aventis US. You can see Sanofi Aventis US's full profile, rating, and other products on pharmaranks.
Is Novafed a brand-name or generic drug?
Novafed is a brand-name product with the active ingredient Pseudoephedrine Hydrochloride. Lower-cost generic equivalents containing Pseudoephedrine Hydrochloride are available — ask your pharmacist.
Is Novafed available over the counter?
No. Novafed is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Novafed come in?
Novafed is currently marketed as capsule, extended release, per the FDA's National Drug Code Directory.
What class of drug is Novafed?
Novafed is classified as alpha-adrenergic agonist, per the FDA's Established Pharmacologic Class.
Is Novafed FDA-registered?
Novafed is on record with the U.S. FDA under application number NDA017603. You can verify this on its official FDA label.
Has Novafed been recalled by the FDA?
Novafed has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Novafed safe?
There's no single safe-or-not verdict. pharmaranks gives Novafed a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

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