FDA-filed SPL labeling · retrieved through openFDA

Ivermectin

Ivermectin is an antiparasitic and anti-inflammatory medication used across several forms to treat intestinal parasites, river blindness, head lice, and inflammatory lesions of rosacea.

Brand names StromectolIvomecBimectinAgrimectinSklice +11 more
Drug classes Antiparasitic
Rx/OTC Forms 2 Routes Topical · Oral
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 26 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 effectiveMar 27, 2024
Clinical labels in scope 26
AvailabilityRx/OTC
Earliest approval/marketing year 1996
FDA-listed product records 93
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 21, 2026
Other forms & routes:
Ivermectin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ivermectin is a well-established antiparasitic available in tablet and topical forms, each approved for specific conditions — tablets for intestinal strongyloidiasis and onchocerciasis, lotions for head lice, and a 1% cream for rosacea. Use only the product and route prescribed for your condition, follow dosing instructions carefully (including whether to take tablets on an empty stomach), and report any unusual neurological symptoms like confusion or extreme drowsiness to your doctor right away. Do not use veterinary formulations — they are not safe for human use.

📖 Ivermectin: Patient Information Guide

A plain-language walkthrough of Ivermectin — 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

Ivermectin is available in multiple forms — tablets, topical lotions, and a topical cream — each approved for specific conditions.

  • Stromectol tablets and ivermectin tablets (oral): treat intestinal strongyloidiasis (a roundworm gut infection caused by Strongyloides stercoralis)
  • Stromectol tablets and ivermectin tablets (oral): treat onchocerciasis (river blindness) caused by Onchocerca volvulus — effective against the microfilariae (immature parasite) stage, not the adult worm
  • RID One and Done, Head Lice Treatment Ivermectin Lotion, Scalp Care Lotions, Ivometn Ivermectin Lice Treatment, lice treatment dedicated, and ivermectin topical lotion: treat head lice in adults and children 6 months and older
  • Soolantra cream and ivermectin cream 1% (topical): treat the inflammatory bumps (lesions) of rosacea on the face
⚙️How it works

Ivermectin belongs to a class of antiparasitic drugs called avermectins. It works by binding tightly to glutamate-gated chloride channels — specialized entry points in the nerve and muscle cells of parasites. When ivermectin locks onto these channels, it causes a flood of chloride ions into the cell, which hyperpolarizes (over-inhibits) the nerve or muscle, leading to paralysis and death of the parasite. These channels exist in invertebrates like worms and lice but not in the same form in mammals, and ivermectin does not readily cross the human blood-brain barrier — which is why it can be selectively toxic to parasites at therapeutic doses.

For the oral tablet form, ivermectin is active against the tissue microfilariae of Onchocerca volvulus and the intestinal stages of Strongyloides stercoralis, but it does not kill adult Onchocerca worms. For rosacea, how the topical cream reduces inflammatory lesions is not known.

💊How it's taken

How ivermectin is taken depends entirely on the product and condition being treated — do not mix up forms or routes.

  • Tablets (strongyloidiasis or onchocerciasis): usually a single oral dose taken on an empty stomach with water; eating a high-fat meal around the dose can significantly increase absorption, so follow your prescriber's timing instructions precisely. Follow-up testing may be needed after treatment.
  • Topical lotion (head lice): applied once to dry hair and scalp, left on for 10 minutes, then rinsed with water only; wait 24 hours before shampooing. This is generally a single-use treatment per infestation.
  • Topical cream 1% (rosacea): applied to affected areas of the face once daily in a thin layer, avoiding the eyes and lips.
🤒Side effects — in detail

Side effects vary by form and condition being treated. Common ones reported with oral ivermectin include:

  • Dizziness, vertigo, or drowsiness
  • Nausea, diarrhea, vomiting, or stomach pain
  • Itching (pruritus), rash, or hives
  • Fatigue or weakness
  • Swelling of the face or limbs
  • Rapid heartbeat (tachycardia)
  • Headache or muscle aches

People treated for onchocerciasis may also experience the Mazzotti reaction — fever, skin rashes, swollen lymph nodes, and joint pain in the first few days — caused by the immune response to dying parasites. If you develop severe confusion, extreme drowsiness, difficulty breathing, seizures, or severe skin blistering, get medical help right away.

⚠️Warnings & precautions
  • Neurotoxicity (nerve toxicity): Serious cases of altered consciousness — including drowsiness, stupor, coma, and death — have been reported with ivermectin tablets, even at recommended doses. Report confusion, extreme sleepiness, or disorientation to your doctor immediately.
  • Mazzotti reaction (onchocerciasis patients): Dying parasites can trigger a strong inflammatory response causing rash, fever, swollen lymph nodes, eye problems, and low blood pressure in the days after treatment. Mild cases are managed with antihistamines or aspirin; severe cases may need IV fluids or steroids.
  • Severe skin reactions: Rare but serious reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (widespread skin peeling/blistering) have been reported — seek emergency care for any severe or spreading skin reaction.
  • Liver effects: Hepatitis and elevated liver enzymes have been reported after the drug was marketed. Tell your doctor if you notice yellowing of the skin or eyes.
  • Veterinary formulations are not safe for people: Exposures to animal ivermectin products have caused rash, neurological symptoms, seizures, and other serious effects.
🔀What it interacts with

Ivermectin has at least one important drug interaction to be aware of:

  • Warfarin (a blood thinner): Taking ivermectin at the same time as warfarin may increase warfarin's blood-thinning effect, raising the risk of bleeding. Your INR (a measure of how long it takes your blood to clot) may need to be checked more closely around the time of ivermectin use.

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
  • Allergy: Do not take ivermectin if you have ever had a serious allergic reaction to it or any of its ingredients.
  • Pregnancy: There are no adequate human studies; animal studies at very high oral doses showed developmental harm. Use during pregnancy only if the benefit clearly outweighs the risk — discuss with your doctor.
  • Breastfeeding: Ivermectin has been detected in breast milk after oral use. The impact on a nursing baby is not well established; talk to your doctor before using.
  • Children: Topical lice lotion products are approved for children 6 months and older, with adult supervision required for children under 12. The safety of ivermectin cream (rosacea) has not been established in children.
  • Older adults: No meaningful difference in safety was seen in adults 65 and older in cream studies, but individual sensitivity cannot be ruled out.
  • Loa loa co-infection risk: People with possible Loa loa infection (a parasite found in parts of Central and West Africa) may be at higher risk for serious neurological reactions — tell your doctor if you have traveled to or live in affected areas.
🚑If you take too much

Taking too much ivermectin — or being exposed to veterinary formulations — can cause serious neurological symptoms including confusion, extreme drowsiness, stupor, coma, and in rare cases death. Other signs of significant exposure include rash, swelling, headache, dizziness, nausea, vomiting, seizures, and difficulty breathing. If you suspect an overdose or significant exposure, seek emergency medical care immediately; treatment is supportive and focuses on maintaining breathing, circulation, and fluid balance.

📡Pharmacodynamics — effects in the body

At therapeutic doses, ivermectin cream is not expected to prolong the QTc interval (the heart's electrical recovery time), meaning it does not carry a known risk of a dangerous heart rhythm from that specific mechanism.

🔬Pharmacokinetics — how your body processes it

After oral ivermectin is taken, blood levels peak at around 4 hours. The drug is primarily broken down by the liver using an enzyme called CYP3A4, and it is cleared almost entirely through the stool over about 12 days — less than 1% leaves the body through urine. The half-life (the time it takes the body to clear half the drug) is approximately 18 hours. Importantly, taking ivermectin tablets with a high-fat meal can increase the amount absorbed by the body by about 2.5 times compared to taking it on an empty stomach, which is why the timing of food matters for oral dosing.

📦How to store it

store at room temperature 68º-77ºF (20º-25ºC) do not freeze keep carton and see Consumer Information Leaflet and warnings before use

📄 Written from Ivermectin’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 →

58

Supplements & herbs that interact with Ivermectin

58 supplements and herbal products have documented interactions with Ivermectin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 37
  • Minor · 18
Every supplement checked against Ivermectin — ranked by severity The full interaction hub: 3 major · 37 moderate · 18 minor · every one linked to its full report. Check Ivermectin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

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

Can I use ivermectin for anything other than what my doctor prescribed it for?
It's important to use ivermectin only for the condition your doctor prescribed it for. The tablet form is approved for two specific parasitic infections — strongyloidiasis and onchocerciasis — while the topical forms are for head lice or rosacea. Using the wrong form for the wrong condition, or using veterinary formulations, can be dangerous. Always follow your prescriber's instructions.
Should I take the ivermectin tablet with food or on an empty stomach?
Ivermectin tablets should be taken on an empty stomach with a full glass of water. Eating a high-fat meal around the time of your dose can increase the amount your body absorbs by about 2.5 times, which could raise the risk of side effects. Unless your doctor specifically tells you otherwise, take it before eating.
What side effects should I just watch for versus ones that mean I need to call for help right away?
Milder side effects like dizziness, itching, nausea, or an upset stomach are fairly common and usually pass on their own. But if you experience confusion, extreme drowsiness, difficulty waking up, seizures, or severe skin blistering or peeling, get medical help immediately — these can be signs of serious reactions. If you're being treated for river blindness, some skin redness, rash, or swollen glands in the first few days after treatment can happen as your body reacts to dying parasites — but let your doctor know if it's severe.
I'm pregnant — is it safe for me to take ivermectin?
There aren't enough good human studies to say it's definitely safe during pregnancy. Animal studies at very high doses showed some developmental problems, though those doses were far above what humans use. If you're pregnant, talk to your doctor before taking or using any form of ivermectin — they can weigh the benefit of treating your condition against the potential risk.
How do I use the ivermectin lotion to treat head lice correctly?
Start with completely dry hair — this is important, the lotion doesn't work the same on wet hair. Apply it directly to your scalp first and work outward to the tips of your hair, making sure every strand and the whole scalp is covered. Leave it on for exactly 10 minutes using a timer, then rinse it out with water only. Wait 24 hours before using shampoo. Children under 12 need an adult to help with the application. You generally don't need to comb out nits for it to work, but you can use a fine-tooth comb if you'd like.
Can ivermectin interfere with any of my other medications?
The main interaction to know about is with warfarin, a common blood thinner. Taking ivermectin at the same time can increase warfarin's effect on your blood's clotting time, which raises bleeding risk. If you take warfarin, make sure your doctor or pharmacist knows you're taking ivermectin so your clotting levels can be monitored. Always give your healthcare team a full list of everything you take.
Is Ivermectin available over the counter?
Both — Ivermectin 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 Ivermectin first available?
Ivermectin has been available in the United States since at least 1996, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Ivermectin?
Ivermectin is supplied by 60 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Merck Sharp & Dohme LLC, Edenbridge Pharmaceuticals LLC..

💬 Answers drafted from Ivermectin’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 Ivermectin comes

Ivermectin is available in 2 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.

Topical cream, ointment or gel

By mouth · On the skin
Brands Head Lice Treatment Ivermectin Lotion118mL Ivometn Ivermectin Lice Treatment Sklice Soolantra SYNTHABIO Ivermectin
How this form is used
What it may be used for
  • RID One and Done, Head Lice Treatment Ivermectin Lotion, Scalp Care Lotions, Ivometn Ivermectin Lice Treatment, lice treatment dedicated, and Ivermectin topical lotion are all used to treat head lice in adults and children 6 months of age and older
Important instructions
  • Hair and scalp must be completely dry before applying any of these topical lotion products
  • Apply the lotion directly to the scalp first, then work outward toward the ends of the hair, making sure to cover all hair and scalp; leave on for 10 minutes, then rinse with water only
  • Wait 24 hours after rinsing before using shampoo; nit combing is not required for the product to work, but a fine-tooth comb may be used to remove dead lice and nits if desired
  • Children 6 months to under 12 years of age must have an adult supervise the application; do not reuse on the same person for the same infestation without talking to a healthcare provider first
Available strengths 5 strengths
43 FDA-listed product records

Tablet

By mouth
Brands Stromectol
How this form is used
What it may be used for
  • Stromectol tablets are used to treat intestinal strongyloidiasis (a roundworm infection of the gut)
  • Stromectol tablets are used to treat onchocerciasis (river blindness) caused by the parasite Onchocerca volvulus — but note they do not kill the adult form of the parasite
  • Ivermectin tablets (generic) are indicated for the same two infections: intestinal strongyloidiasis and onchocerciasis
Important instructions
  • Stromectol and ivermectin tablets should be taken on an empty stomach with a full glass of water
  • These are typically given as a single dose; your doctor will determine if a repeat dose is needed based on follow-up testing
  • Eating a high-fat meal around the time of the dose can significantly increase how much the body absorbs — follow your prescriber's specific timing instructions
  • After treatment for strongyloidiasis, follow-up stool tests are recommended to confirm the infection has cleared
Available strengths 2 strengths
19 FDA-listed product records

📊 Ivermectin across the U.S. market

How Ivermectin 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.

2
Dose forms
60
Manufacturers
10
Brand names
93
FDA-listed product records
1996
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 (31) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack5%
Merck Sharp & Dohme LLC4%
Edenbridge Pharmaceuticals LLC.4%
Chemo Biosynthesis s.r.l.4%
Viona Pharmaceuticals Inc4%
A-S Medication Solutions4%
Other makers74%

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

📈 How widely Ivermectin is used

A general measure of how commonly Ivermectin 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 Ivermectin 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.

55,437
Medicaid prescriptions filled (Q1–Q4 2025)
$5.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ivermectin prescribed? Of the 1,596 medications we measure, Ivermectin ranks #616 by Medicaid prescriptions — more than 61% of them.

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

Utilization by Ivermectin 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 3 mg oral tablet is the most-dispensed Ivermectin product — about 62% of these Medicaid prescriptions.

ivermectin 3 MG Oral Tablet Most dispensed

34,229 Medicaid prescriptions (Q1–Q4 2025) 62% of Ivermectin prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $37 per prescription (gross)

Summed across the 5 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311207

ivermectin 10 MG/ML Topical Cream

17,554 Medicaid prescriptions (Q1–Q4 2025) 32% of Ivermectin prescriptions shown $3.3M gross reimbursement (before rebates) ≈ $190 per prescription (gross)

Summed across the 5 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1598068

ivermectin 5 MG/ML Topical Lotion

2,839 Medicaid prescriptions (Q1–Q4 2025) 5% of Ivermectin prescriptions shown $415,830 gross reimbursement (before rebates) ≈ $146 per prescription (gross)

Summed across the 2 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1246673

ivermectin 6 MG Oral Tablet

815 Medicaid prescriptions (Q2–Q4 2025) 1% of Ivermectin prescriptions shown $66,315 gross reimbursement (before rebates) ≈ $81 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199998

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 Ivermectin, 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 59 listed Ivermectin NDCs with Medicaid activity.

🔍 Compare Ivermectin products

A representative set of FDA-listed product records for Ivermectin — 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 93 of 93 products — FDA National Drug Code Directory. See every product, package size and price: browse all 93 Ivermectin 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) Ivermectin RxCUI 6069 7 dose forms · 10 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 902281 No current FDA listing
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 902282
  2. Dose form (SCDF) Oral Paste RxCUI 1363362 In current FDA listings
    Clinical drug / strength (SCD) 0.0187 MG/MG RxCUI 1363363
  3. Dose form (SCDF) Oral Solution RxCUI 995488 No current FDA listing
    Clinical drug / strength (SCD) 0.8 MG/ML RxCUI 995489 10 MG/ML RxCUI 1546195 18.7 MG/ML RxCUI 2739752
  4. Dose form (SCDF) Oral Tablet RxCUI 370726 In current FDA listings
    Clinical drug / strength (SCD) 3 MG RxCUI 311207 6 MG RxCUI 199998
  5. Dose form (SCDF) Topical Cream RxCUI 1598067 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 1598068
  6. Dose form (SCDF) Topical Lotion RxCUI 1246672 In current FDA listings
    Clinical drug / strength (SCD) 5 MG/ML RxCUI 1246673
  7. Dose form (SCDF) Topical Solution RxCUI 867596 No current FDA listing
    Clinical drug / strength (SCD) 5 MG/ML RxCUI 978030

Look up RxCUI 6069 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

Stromectol Ivomec Bimectin Agrimectin Sklice DuraMectin Promectin Vetrimec Soolantra Strideguard Zimecterin Noromectin Ivermax SYNTHABIO Ivermectin Head Lice Treatment Ivermectin Lotion118mL ivometn ivermectin lice treatment

🏭 Manufacturers & labelers

Bryant Ranch Prepack 4 Merck Sharp & Dohme LLC 3 Edenbridge Pharmaceuticals LLC. 3 Chemo Biosynthesis s.r.l. 3 Viona Pharmaceuticals Inc 3 A-S Medication Solutions 3 Actavis Pharma, Inc. 3 Shenzhen Mengyue Technology Co., Ltd. 2 Padagis US LLC 2 Padagis Israel Pharmaceuticals Ltd 2 Shenzhen Xuyan Technology Co., Ltd. 2 NuCare Pharmaceuticals,Inc. 2 Rite Aid Corporation 2 Willow Birch Pharma, Inc. 2 Laksh Fine Chem Private Limited 2 Hovione PharmaScience Limited 2 Galderma Laboratories, L.P. 2 Shenzhen Zhenshangzekai Technology Co., Ltd. 2 Advagen Pharma Ltd 2 CVS Pharmacy 2 Walmart Inc. 2 Bills Biotech Private Limited 2 Zydus Lifesciences Limited 2 AX Pharmaceutical Corp 2

…and 16 more on the FDA NDC directory.

RxNorm drug class

Ivermectin belongs to the Antiparasitic class.

Pharmacologic class Antiparasitic, Pediculicide
Drug family (ATC) Other dermatologicals, Avermectines

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 Mar 27, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ivermectin.
📈
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 Ivermectin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
26
NDC products indexed
93
Distinct labelers/manufacturers represented
60
Linked representative label
Viona Pharmaceuticals Inc
Linked label effective
Mar 27, 2024
Composite sections available
23
Linked SPL Set ID
6b4a7400-d34c-4947-90e6-340f7087a702
Linked SPL Document ID
23a90438-439e-4a43-86a1-ea2343657d85
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 26 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. Viona Pharmaceuticals Inc 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.