FDA-filed SPL labeling · retrieved through openFDA

Oxymetazoline

Oxymetazoline is a decongestant and blood vessel-narrowing medication used across several product forms to temporarily relieve nasal congestion, treat persistent facial redness from rosacea, and lift drooping upper eyelids.

Brand names AfrinAllerest 12 Hour Nasal SprayDristan 12-Hour Nasal SprayDuramist PlusNeo-Synephrine 12 Hour +11 more
Drug class ⓘ Vasoconstrictor
Rx/OTC Forms 6 Routes Nasal · Topical · Ophthalmic
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 198 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveDec 11, 2023
Clinical labels in scope ⓘ198
AvailabilityRx/OTC
Earliest approval/marketing year ⓘ1975
FDA-listed product records ⓘ498
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 26, 2026 🚨Recall on record · 3
Other forms & routes:
⭐ Oxymetazoline at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Oxymetazoline is a versatile medication available in nasal sprays for congestion relief, a prescription cream (Rhofade) for rosacea facial redness, and prescription eye drops (Upneeq) for drooping upper eyelids. Use each product only as directed for its specific form — nasal sprays should not be used for more than 3 days in a row to avoid rebound congestion. If you have heart disease, high blood pressure, glaucoma, or take blood pressure medications, talk to your doctor or pharmacist before starting any oxymetazoline product.

📖 Oxymetazoline: Patient Information Guide

A plain-language walkthrough of Oxymetazoline — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Oxymetazoline is available in several different product forms, each approved for a specific use.

  • Nasal sprays (including Afrin, Dristan, CVS Severe Nasal Congestion Relief, Assured Nasal Relief Original, Best Choice, and Family Care Nasal Relief): temporarily relieve nasal congestion, sinus pressure, and swollen nasal passages caused by colds, hay fever, or other upper respiratory allergies
  • Rhofade (topical cream): treats persistent facial redness (erythema) in adults with rosacea
  • Oxymetazoline Hydrochloride (topical cream): treats persistent facial redness (erythema) in adults with rosacea
  • Upneeq (eye drops): treats acquired blepharoptosis — a drooping of the upper eyelid in adults that develops over time
  • No More Nosebleed (topical solution): temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies, and helps shrink swollen nasal membranes
⚙️How it works▾

Oxymetazoline is an alpha-adrenergic agonist — it activates a type of receptor (alpha-adrenoceptors) found in the walls of blood vessels and in certain muscles. When activated, these receptors cause blood vessels to narrow (vasoconstriction), reducing swelling and redness. In the nose, this shrinks swollen membranes so air can pass more freely. Applied as a cream for rosacea, the same narrowing of blood vessels reduces visible facial redness. In Upneeq eye drops, oxymetazoline specifically targets alpha-1A receptors in Mueller's muscle in the upper eyelid, causing it to contract and lift a drooping lid.

💊How it's taken▾

The right way to take oxymetazoline depends completely on which product form you are using — dosing routines are distinct and should not be mixed.

  • Nasal sprays: adults and children 6 and older use 2–3 sprays in each nostril no more than every 10–12 hours, with a maximum of 2 doses in 24 hours; do not use for more than 3 days in a row
  • Rhofade / Oxymetazoline Hydrochloride cream: apply a pea-sized amount once daily to the entire face, avoiding eyes and lips; wash hands immediately after
  • Upneeq eye drops: instill one drop into the affected eye(s) once daily; remove contacts first and wait 15 minutes before reinserting

Always follow your prescriber's or pharmacist's directions for the specific product you have been given or purchased.

🤒Side effects — in detail▾

The side effects you might notice depend on which form of oxymetazoline you are using.

  • Skin irritation (dermatitis) at the cream application site
  • Worsening of rosacea inflammatory lesions with the cream
  • Itching, redness, or pain at the cream application site
  • Burning, stinging, or sneezing with nasal spray use
  • Temporary increase in nasal discharge with nasal spray use

Seek immediate medical attention if you develop eye pain, blurred vision, sensitivity to light, or sudden redness of the eye — these can be warning signs of acute angle closure glaucoma. If swallowed accidentally (especially by a child), call Poison Control right away.

⚠️Warnings & precautions▾
  • Do not use nasal sprays for more than 3 days. Using them longer or more often can cause rebound congestion — your stuffiness comes back worse than before.
  • Oxymetazoline can affect blood pressure. People with severe cardiovascular disease, uncontrolled high or low blood pressure, or blood pressure that drops when standing (orthostatic hypotension) should use any form with caution and watch for changes.
  • Upneeq may increase the risk of angle closure glaucoma in people with untreated narrow-angle glaucoma. Get immediate medical care if you develop eye pain, redness, blurred vision, or light sensitivity.
  • A drooping eyelid (ptosis) can sometimes signal serious conditions like stroke, myasthenia gravis, or Horner syndrome. See your doctor if other neurological symptoms are present.
  • Keep all oxymetazoline products — especially nasal sprays and creams — out of reach of children. Accidental swallowing can cause serious effects in children.
  • Do not share nasal spray containers — this can spread infection.
🔀What it interacts with▾

Oxymetazoline can interact with several types of medications, particularly those that affect blood pressure or the nervous system.

  • Beta-blockers and antihypertensives (blood pressure medications): oxymetazoline may alter blood pressure and could add to or counteract the effects of these drugs
  • Cardiac glycosides (medicines like digoxin used for heart conditions): use together with caution due to potential cardiovascular effects
  • Alpha-adrenergic receptor antagonists (used for cardiovascular disease or enlarged prostate): interaction possible due to opposing effects on the same receptors
  • MAO inhibitors (a class of antidepressants such as phenelzine or tranylcypromine): caution advised, as MAO inhibitors affect how the body processes circulating amines, which can change how oxymetazoline behaves

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Tell your doctor if you have heart disease, high blood pressure, or any serious cardiovascular condition
  • Tell your doctor if you have thyroid disease, diabetes, or trouble urinating due to an enlarged prostate — particularly relevant for nasal spray use
  • Tell your doctor if you have narrow-angle glaucoma — Upneeq eye drops may raise the risk of angle closure
  • Tell your doctor if you have Sjögren's syndrome or reduced blood flow to the brain or heart
  • Tell your doctor if you have orthostatic hypotension (blood pressure that drops when you stand)
  • Pregnancy: there is a potential association between nasal spray use in the second trimester and kidney development concerns in the baby. There are no adequate studies of the cream in pregnant women. Ask a health professional before using any oxymetazoline product while pregnant
  • Breastfeeding: it is unknown how much oxymetazoline passes into breast milk in humans. Discuss the benefits and risks with your doctor
  • Children: Oxymetazoline Hydrochloride cream has not been studied in children under 18. Nasal spray products should not be used in children under 6 without a doctor's guidance
  • Older adults (65+): no major differences in safety or effectiveness were found in clinical trials for the cream, but individual circumstances vary — check with your prescriber
🚑If you take too much▾

Oxymetazoline cream is not for swallowing — if it is ingested accidentally, seek medical advice right away and monitor closely. Accidental swallowing of nasal spray products (which contain oxymetazoline) has caused serious problems in children, including nausea, vomiting, extreme drowsiness, slow or fast heart rate, low blood pressure, difficulty breathing, and in severe cases, stupor or coma. If this happens, call Poison Control at 1-800-222-1222 or go to an emergency room immediately.

📡Pharmacodynamics — effects in the body▾

In clinical studies of Upneeq eye drops, the effect on eyelid lift was measured using a standardized distance called MRD1 (the gap between the center of the pupil light reflex and the upper eyelid margin — basically, how much of your pupil is visible). The greatest lift in eyelid position was seen about 2 hours after using Upneeq, and the effect continued to be measurable through 8 hours after dosing.

🔬Pharmacokinetics — how your body processes it▾

After oxymetazoline cream is applied to the face, small amounts are absorbed into the bloodstream — levels were measurable in most people studied, but remained very low. The drug is roughly 57% bound to proteins in the blood. It is minimally broken down (metabolized) by the liver — about 96% of the original drug remained unchanged after 2 hours in lab studies. How the body ultimately eliminates oxymetazoline after cream use has not been fully characterized. Lab studies also showed that oxymetazoline does not significantly interfere with the liver enzymes (CYP450) that process many other medications.

📦How to store it▾

store between 20° and 25°C (68° to 77°F) retain carton for future reference on full labeling

📄 Written from Oxymetazoline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Oxymetazoline — the kind of thing our pharmacy team would talk through with you at the counter.

Can I use the nasal spray every day for my chronic stuffiness? ▾
It's really important not to use the nasal spray for more than 3 days in a row. If you keep using it longer, your nose can actually become dependent on it — and when you stop, the congestion comes back even worse. That's called rebound congestion. If your stuffiness is ongoing, talk to your doctor about longer-term options that are safer for daily use.
I take blood pressure medication. Is it okay to use oxymetazoline? ▾
You should check with your doctor or pharmacist first. Oxymetazoline can affect blood pressure on its own, and it can interact with antihypertensive drugs like beta-blockers. This applies to all forms — nasal spray, cream, and eye drops. It doesn't mean you can't use it, but your care team should know so they can keep an eye on things.
What exactly does Upneeq do, and how quickly will I see a difference? ▾
Upneeq is a prescription eye drop that lifts a drooping upper eyelid — a condition called blepharoptosis. It works by stimulating a small muscle inside the eyelid. In clinical studies, the maximum lift was seen about 2 hours after the drop, and the effect lasted through 8 hours. It's used once a day. If you wear contacts, remove them before putting in the drop, and wait 15 minutes before putting them back in.
Can I use Rhofade cream with other skincare products or medications? ▾
Rhofade is applied once a day to the whole face in a thin, pea-sized layer. The label doesn't give specific guidance on layering with other skincare products, so your best bet is to ask your dermatologist or pharmacist. What's clear is that it's for external use only — keep it away from your eyes and lips — and you should wash your hands right after applying it.
Is oxymetazoline safe to use during pregnancy? ▾
This is something you really should run by your doctor or midwife before using. There's a possible link between nasal spray use in the second trimester of pregnancy and a rare kidney development issue in babies. There's also very limited safety data on the cream during pregnancy. It doesn't mean you absolutely can't use it, but it's not a decision to make on your own — your provider can weigh the risks and benefits for your specific situation.
My child accidentally got into the nasal spray. What should I do? ▾
Call Poison Control right away at 1-800-222-1222, or take your child to the emergency room. Accidental swallowing of oxymetazoline nasal spray is a known danger in children and can cause serious effects including extreme drowsiness, slow or fast heart rate, and breathing problems. Don't wait for symptoms to develop — get help immediately and keep all oxymetazoline products locked away and out of reach.
Is Oxymetazoline available over the counter? ▾
Both — Oxymetazoline is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Oxymetazoline first available? ▾
Oxymetazoline has been available in the United States since at least 1975, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Oxymetazoline? ▾
Oxymetazoline is supplied by 110 manufacturers listed in the FDA NDC Directory, including Bayer HealthCare LLC., Best Choice (valu Merchandisers Company), Discount Drug Mart.

💬 Answers drafted from Oxymetazoline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Oxymetazoline comes

Oxymetazoline is available in 6 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Nasal spray

In the nose
Brands Afrin Best Choice Nasal Nostrilla Topcare Nasal
How this form is used
What it may be used for
  • Temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies
  • Temporarily relieves sinus congestion and pressure
  • Helps clear nasal passages and shrinks swollen nasal membranes
Important instructions
  • Adults and children 6 and older: use 2 or 3 sprays in each nostril no more than every 10 to 12 hours; do not exceed 2 doses in 24 hours
  • Children under 6: consult a doctor before use
  • Do not use for more than 3 days — prolonged use may cause congestion to return or worsen
  • Shake well before use; do not tilt your head when inserting the nozzle, and wipe the nozzle clean after each use
Available strengths 15 strengths
Show 9 more strengths Show fewer strengths
465 FDA-listed product records ⓘ

Topical cream, ointment or gel

On the skin
Brands Rhofade
How this form is used
What it may be used for
  • Rhofade is used for the topical treatment of persistent facial redness (erythema) associated with rosacea in adults
  • Oxymetazoline Hydrochloride cream is used for the topical treatment of persistent facial redness (erythema) associated with rosacea in adults
Important instructions
  • Rhofade and Oxymetazoline Hydrochloride cream: apply a pea-sized amount once daily in a thin layer covering the entire face — forehead, nose, each cheek, and chin — while avoiding the eyes and lips
  • Rhofade pump bottle: prime the pump before first use by depressing it until cream is dispensed, then pump 3 more times and discard that cream; priming is only needed once
  • For topical use only — not for oral, ophthalmic, or intravaginal use
  • Wash hands immediately after applying
Available strengths 2 strengths
7 FDA-listed product records ⓘ

Topical solution

On the skin
Brands No More Nosebleed
How this form is used
What it may be used for
  • No More Nosebleed: temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies
  • No More Nosebleed: temporarily relieves sinus congestion and pressure and helps shrink swollen nasal membranes
Available strengths 2 strengths
7 FDA-listed product records ⓘ

Eye drops

In the eye
Brands Upneeq
How this form is used
What it may be used for
  • Upneeq is used to treat acquired blepharoptosis (drooping of the upper eyelid) in adults
Important instructions
  • Upneeq: instill one drop into the affected eye(s) once daily
  • Upneeq: remove contact lenses before using and wait at least 15 minutes before reinserting them
  • Upneeq: if using another eye drop at the same time, wait at least 15 minutes between each product
  • Upneeq: discard the single-use container immediately after dosing and do not touch the tip to your eye or any surface
Available strengths 1 strength
4 FDA-listed product records ⓘ

Topical spray

On the skin
Brands Afrin
Available strengths 1 strength
3 FDA-listed product records ⓘ

Nasal topical

In the nose
Available strengths 1 strength
2 FDA-listed product records ⓘ

📊 Oxymetazoline across the U.S. market

How Oxymetazoline appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

6
Dose forms ⓘ
110
Manufacturers
40
Brand names
498
FDA-listed product records ⓘ
1975
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (9) · Kit (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bayer HealthCare LLC.9%
Best Choice (valu Merchandisers Company)6%
Discount Drug Mart6%
Topco Associates LLC4%
Procter & Gamble Manufacturing GmbH4%
Cvs Pharmacy, Inc.3%
Other makers68%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Oxymetazoline is used

A general measure of how commonly Oxymetazoline is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Oxymetazoline is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

20,124
Medicaid prescriptions filled (Q1–Q4 2025)
$2.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Oxymetazoline prescribed? Of the 1,597 medications we measure, Oxymetazoline ranks #796 by Medicaid prescriptions — more than 50% of them.

Where Oxymetazoline ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Oxymetazoline product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.5 mg/mL nasal spray is the most-dispensed Oxymetazoline product — about 86% of these Medicaid prescriptions.

oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray Most dispensed

17,358 Medicaid prescriptions (Q1–Q4 2025) 86% of Oxymetazoline prescriptions shown $165,829 gross reimbursement (before rebates) ≈ $9.55 per prescription (gross)

Summed across the 11 of 351 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000990

oxymetazoline hydrochloride 10 MG/ML Topical Cream

2,766 Medicaid prescriptions (Q1–Q4 2025) 14% of Oxymetazoline prescriptions shown $1.9M gross reimbursement (before rebates) ≈ $705 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1869816

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Oxymetazoline, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 13 of 356 listed Oxymetazoline NDCs with Medicaid activity.

🔍 Compare Oxymetazoline products

A representative set of FDA-listed product records for Oxymetazoline — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 498 products — FDA National Drug Code Directory. See every product, package size and price: browse all 498 Oxymetazoline NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Oxymetazoline RxCUI 7812 5 dose forms · 10 strengths
  1. Dose form (SCDF) Nasal Gel RxCUI 2474263 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 0.0005 MG/MG RxCUI 2474264
  2. Dose form (SCDF) Nasal Solution RxCUI 377397 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 0.25 MG/ML RxCUI 1000978 hydrochloride 0.5 MG/ML RxCUI 1000987
  3. Dose form (SCDF) Ophthalmic Solution RxCUI 377448 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 0.25 MG/ML RxCUI 1000981 hydrochloride 0.5 MG/ML RxCUI 1001378 hydrochloride 1 MG/ML RxCUI 2391749
  4. Dose form (SCDF) Topical Cream RxCUI 1869815 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 1869816

Look up RxCUI 7812 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Afrin Allerest 12 Hour Nasal Spray Dristan 12-Hour Nasal Spray Duramist Plus Neo-Synephrine 12 Hour Nostrilla Sinex Long-Acting Sudafed OM Zicam Sinus Relief Sinufrin Plus Qlearquil Nasal Decongestant Rhofade Upneeq nasal Best Choice Topcare Nasal

🏭 Manufacturers & labelers

Bayer HealthCare LLC. 31 Best Choice (valu Merchandisers Company) 21 Discount Drug Mart 20 Topco Associates LLC 15 Procter & Gamble Manufacturing GmbH 14 Cvs Pharmacy, Inc. 12 WinCo FOODS, LLC 12 Strategic Sourcing Services LLC 12 Rite Aid Corporation 11 Safeway 10 Kroger Company 9 Chain Drug Marketing Association 9 Publix Super Markets, Inc 9 Lil' Drug Store Products, Inc. 9 Dolgencorp, LLC 9 L. Perrigo Company 9 Amerisource Bergen 9 Lil' Drug Store Products, Inc 8 Meijer Distribution Inc 8 H E B 7 CVS Health 7 A-S Medication Solutions 7 Amazon.com Services LLC 7 American Sales Company 7

…and 16 more on the FDA NDC directory.

RxNorm drug class

Oxymetazoline belongs to the Vasoconstrictor class.

Pharmacologic class Vasoconstrictor
Drug family (ATC) Other dermatologicals, Sympathomimetics, plain, Sympathomimetics used as decongestants

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 11, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Oxymetazoline.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Oxymetazoline after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
198
NDC products indexed
498
Distinct labelers/manufacturers represented
110
Linked representative label ⓘ
FAMILY DOLLAR (Family Wellness)
Linked label effective
Dec 11, 2023
Composite sections available
11
Linked SPL Set ID
0c006b1c-8ab2-4b9c-8738-e7001c1bb47d
Linked SPL Document ID
3c853555-c557-4b90-bc8f-277c59c65cbe
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 198 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. FAMILY DOLLAR (Family Wellness) is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.