What Sudafed does

Sudafed is a consumer health brand providing over-the-counter (OTC) relief from nasal and sinus congestion, sinus pressure, sinus headaches, and head congestion associated with the common cold, allergies, hay fever, and upper respiratory infections. The brand is owned and operated by Kenvue Brands LLC, a New Jersey-domiciled subsidiary of publicly traded Kenvue Inc. (NYSE: KVUE), which spun off from Johnson & Johnson in 2023. Sudafed's core technology rests on three small-molecule active pharmaceutical ingredients — pseudoephedrine HCl (behind-the-counter oral decongestant), phenylephrine HCl (open-shelf oral decongestant), and oxymetazoline HCl 0.05% (topical nasal spray) — delivered in tablets, caplets (immediate and 12-hour extended release), nasal sprays (including no-drip and cooling menthol formulations), saline nasal mists, and pediatric liquids for children aged 4+. The portfolio also features combination products pairing decongestants with acetaminophen, ibuprofen, naproxen sodium, guaifenesin, and dextromethorphan for multi-symptom relief.

The business model is one-time retail purchase of OTC pharmaceutical SKUs distributed through U.S. retail pharmacies and drug stores. Pseudoephedrine-containing products are sold behind the pharmacy counter under the federal Combat Methamphetamine Epidemic Act (CEMA) of 2006, requiring photo ID and monthly purchase limits, while phenylephrine, oxymetazoline, and saline SKUs are sold on open shelves. Sudafed targets a horizontal consumer base — adults with cold, allergy, and sinus symptoms, plus parents of children aged 4+ — through content marketing on sudafed.com, social media, email/rewards programs (available to Nevada and Washington residents), coupons, and in-store pharmacist consultation. The brand is marketed as the #1 pharmacist recommended OTC oral decongestant with 60+ years of continuous market presence.

Sudafed's strategic posture is defined by a dual-API hedge (pseudoephedrine plus phenylephrine) to navigate shifting regulatory landscapes, expansion into topical (oxymetazoline) and non-medicated (saline) adjacencies, and a children's sub-line that broadens the household buyer base. The brand is now exposed to a material regulatory event: the FDA's November 8, 2024 proposed order to remove oral phenylephrine from the OTC monograph, which would affect a substantial share of the SUDAFED PE® product family unless the order is reversed or modified in the final rulemaking.

Name

Sudafed

Legal name

Kenvue Brands LLC

Website

https://sudafed.com

Company type

Public

Operating status

Operating

Headcount range

51–100 employees

Short description

Sudafed is an over-the-counter nasal decongestant brand owned by Kenvue Inc., offering pseudoephedrine, phenylephrine, oxymetazoline, and saline products for adults and children with cold, allergy, and sinus symptoms sold through U.S. retail pharmacies.

Ownership category

akta.pro rank

Product category

OTC Pharmaceuticals

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Cold, Flu & Cough Remedies (HLAIADAB)

akta.pro secondary industries

Allergy, Sinus & Respiratory (Non-Asthma) (HLAIADAC), Cold, Flu, Cough & Allergy Remedies (Decongestants, Antihistamines, Cough Syrups, Lozenges) (CRADAMAD), Nasal Drug Delivery Devices (Sprays/Powder Devices) (HLAHAIAK), OTC Pain Relief & Fever (Analgesics, Anti-inflammatory, Topical Pain Relief) (CRADAMAC)

Keywords

• Nasal decongestants
• OTC cold medicine
• Sinus congestion relief
• Pharmacy retail products
• Pediatric decongestants

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Marketing or Sales, Operations, Personnel

Revenue model

1. OTC Pharmaceutical Retail Sales: Sudafed generates revenue through one-time retail purchases of OTC decongestant products sold through pharmacies, drug stores, and retail outlets. Products are available in multiple formulations including tablets, caplets, nasal sprays, and liquids targeting consumers with cold, allergy, and sinus congestion symptoms.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Sudafed sells over-the-counter nasal decongestant medications for relief of sinus and head congestion, common cold, and allergy symptoms. The portfolio spans oral tablets and caplets, medicated nasal sprays, saline nasal mist, and children's liquids across SUDAFED® (pseudoephedrine HCl, behind-the-counter), SUDAFED PE® (phenylephrine HCl, OTC shelves), and SUDAFED® OM (oxymetazoline HCl nasal spray) lines. Products are distributed through U.S. retail pharmacies and drug stores.

Product overview

Sudafed is a comprehensive over-the-counter (OTC) nasal decongestant brand offering both behind-the-counter (pseudoephedrine-based) and OTC (phenylephrine-based and oxymetazoline-based) products. The portfolio includes oral tablets and caplets (SUDAFED® and SUDAFED PE® lines), nasal sprays (SUDAFED® OM line with oxymetazoline), saline nasal mists, and children's liquid formulations. Key product families include: (1) SUDAFED® products with pseudoephedrine HCl requiring pharmacy counter purchase, available as immediate-release tablets (30 mg) and extended-release caplets (120 mg 12-hour); (2) SUDAFED PE® products with phenylephrine available OTC, including sinus pressure/pain relief, head congestion formulations, and day/night options; (3) SUDAFED® OM medicated nasal sprays with oxymetazoline HCl (0.05%) offering fast-acting 12-hour relief in original and cooling menthol no-drip formulations; (4) Non-medicated saline nasal spray with aloe for moisturizing; (5) Children's liquid decongestants in various flavors. The brand is marketed as the #1 pharmacist recommended oral OTC decongestant brand.

Differentiator

Problem solved

Functional benefit

Products and services

• SUDAFED® Sinus Congestion 12 Hour Relief Maximum Strength Decongestant Caplets

Quantifiable outcome

• Starts working in seconds for nasal sprays
• +2 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Xlear: Xlear sells xylitol-based saline nasal sprays and sinus care products, competing in the non-medicated nasal spray segment alongside Sudafed's saline mist with aloe.

Broad incumbents

• Tylenol Cold & Flu / Tylenol Sinus: Tylenol (Johnson & Johnson) extends its acetaminophen franchise into cold, flu, and sinus combination products, directly competing with Sudafed's phenylephrine-plus-acetaminophen SKUs.
• Vicks: Vicks (Procter & Gamble / Haleon) is a heritage multi-symptom cold and flu brand (NyQuil, DayQuil, VapoRub, Formula 44) that overlaps Sudafed in cold/sinus/cough remedies across U.S. retail shelves.
• Zyrtec: Zyrtec (Kenvue, Sudafed's sister brand) is a top OTC antihistamine; both brands live under Kenvue Brands LLC and target overlapping allergy/sinus symptom occasions.
• Claritin: Claritin (Bayer) is a leading OTC non-drowsy antihistamine for allergies; it competes with Sudafed's allergy/sinus use cases via a different mechanism and is an alternative rather than a substitute in many congestion journeys.
• Advil Cold & Sinus / Aleve-D: Advil/Aleve-D (Haleon/Bayer) offer ibuprofen- and naproxen-based decongestant combinations that overlap with Sudafed PE Pressure + Pain and 12-Hour Pressure + Pain caplets on the same retail shelves.
• Robitussin: Robitussin (Haleon) is a major OTC cough, cold, and chest-congestion brand that competes with Sudafed's multi-symptom tablets and Children's PE Cough + Cold SKU.

Direct peers

• Afrin: Afrin (Bayer) markets oxymetazoline-based nasal decongestant sprays, the same active ingredient and dosage form used in Sudafed's OM nasal-spray line, making it the closest direct competitor in topical nasal decongestion.
• Mucinex: Mucinex (Reckitt) is a leading U.S. OTC brand for chest congestion, cough, and sinus/cold symptom relief, including guaifenesin expectorants and combination decongestant SKUs sold in similar retail-pharmacy channels.
• NeilMed Pharmaceuticals: NeilMed specializes in saline nasal irrigation (sinus rinse bottles, saline sprays) — overlapping with Sudafed's saline nasal mist line and competing for consumers seeking drug-free congestion relief.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/SUDAFED

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sudafed