FDA-filed SPL labeling · retrieved through openFDA

Haloperidol

Haloperidol is an antipsychotic medication used to manage psychotic disorders, control tics in Tourette's disorder, and treat severe behavior problems in children.

Brand names HaldolHaloperidol DecanoateHaloperidol LactateHaldol Decanoate
Drug class Typical Antipsychotic
Rx Forms 3 Routes Oral · Intramuscular
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 80 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 effectiveNov 15, 2024
Clinical labels in scope 80
AvailabilityRx
Earliest approval/marketing year 1967
FDA-listed product records 502
Boxed warningYes
How we combine label and product data →
Other forms & routes:
Haloperidol at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Haloperidol is a well-established antipsychotic that can be very effective for psychotic symptoms, Tourette's tics, and certain severe behavior problems in children — but it requires careful monitoring, especially for movement side effects and heart rhythm changes. It is not safe or approved for older adults with dementia-related psychosis. Work closely with your prescriber to find the lowest effective dose and report any new or unusual symptoms right away.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Important safety warning: Haloperidol should NOT be used to treat dementia-related psychosis in elderly patients. Studies show that older adults with dementia who take antipsychotic drugs — including haloperidol — have a significantly higher risk of death compared to those taking a placebo. The deaths were most often related to heart problems (like heart failure or sudden cardiac death) or infections like pneumonia. Haloperidol is not approved for this use. If you have a loved one with dementia who is being considered for this medication, speak with their doctor about the risks.

Read the full warning on DailyMed →

📖 Haloperidol: Patient Information Guide

A plain-language walkthrough of Haloperidol — 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

Haloperidol is prescribed for several conditions involving the brain and behavior. Main uses include:

  • Psychotic disorders — managing symptoms like hallucinations and disorganized thinking
  • Tourette's disorder — controlling tics and involuntary vocal outbursts in children and adults
  • Severe behavior problems in children — explosive, combative behavior that can't be explained by immediate provocation
  • Hyperactivity with conduct disorders in children — impulsivity, aggression, mood swings, and poor frustration tolerance when other treatments have failed
⚙️How it works

Haloperidol works primarily by blocking dopamine type 2 receptors in the brain. Dopamine is a chemical messenger that plays a key role in mood, perception, and movement. When dopamine activity is excessive or dysregulated, it can contribute to hallucinations, delusions, and disorganized behavior. By blocking these receptors, haloperidol helps reduce those overactive signals.

It also has some activity at alpha-1 adrenergic receptors and minimal activity at other receptor types. The exact way all of this adds up to treat psychosis is not fully understood, but the dopamine-blocking effect is believed to be central to how it helps.

💊How it's taken

Haloperidol tablets are taken by mouth, usually two or three times a day. Your prescriber will start you at a dose appropriate for your age, the severity of your symptoms, and any other medications you take — then adjust from there.

  • Older adults and children typically start at lower doses and are increased slowly
  • Children ages 3–12 may use this medication; it is not intended for children under 3
  • The dose is highly individualized — never adjust your dose without talking to your prescriber first
🤒Side effects — in detail

Some side effects are common, especially when starting haloperidol or increasing the dose:

  • Muscle stiffness, tremor, or slow movement (Parkinson-like symptoms)
  • Restlessness or an uncontrollable need to move (akathisia)
  • Involuntary muscle spasms, especially in the neck or face (dystonia)
  • Drowsiness or sedation
  • Fast heartbeat (tachycardia)
  • Low blood pressure (hypotension), which can cause dizziness when standing
  • Changes in heart rhythm visible on an ECG

Seek immediate medical attention if you develop uncontrolled repetitive movements, severe muscle rigidity with fever, throat tightness or trouble breathing, or if you feel faint or have an irregular heartbeat.

⚠️Warnings & precautions
  • Tardive dyskinesia: Long-term use can cause potentially permanent involuntary movements — often of the face, tongue, or limbs. Risk increases with dose and duration. There is no established treatment. Report any unusual movements to your doctor right away.
  • Heart rhythm changes (QT prolongation): Haloperidol can alter heart electrical activity, raising the risk of a dangerous arrhythmia called Torsades de pointes. Risk is higher at higher doses and in people with underlying heart conditions or low potassium/magnesium.
  • Elderly patients with dementia: This drug is NOT approved for dementia-related psychosis. Studies show a significantly increased risk of death in elderly dementia patients treated with antipsychotics.
  • Acute dystonia: Sudden, painful muscle contractions — especially of the neck and throat — can occur early in treatment. Young males are at higher risk. Get medical help immediately if this happens.
🔀What it interacts with

Haloperidol interacts with several medications and substances — always tell your prescriber and pharmacist everything you take:

  • QT-prolonging drugs — combining these with haloperidol significantly increases the risk of dangerous heart rhythm problems
  • Ketoconazole (antifungal) — a strong blocker of the CYP3A4 enzyme that breaks down haloperidol, leading to higher drug levels in the blood
  • Paroxetine (antidepressant) — blocks CYP2D6, another enzyme involved in haloperidol metabolism, also raising blood levels
  • Sodium valproate — can interfere with one of the pathways used to clear haloperidol from the body
  • Epinephrine (adrenaline) — should NOT be used in overdose situations involving haloperidol

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
  • Parkinson's disease: Do not take haloperidol — it is contraindicated
  • Comatose state or severe CNS depression: Do not take haloperidol
  • Allergy to haloperidol: Do not take this medication
  • Dementia-related psychosis in elderly patients: Haloperidol is not approved for this and carries a serious risk of death
  • Liver problems: Haloperidol is heavily processed in the liver; levels can build up and should be monitored
  • Heart rhythm problems or electrolyte imbalances: Particularly low potassium or magnesium — these increase the risk of dangerous arrhythmias
  • Older adults: Drug levels tend to be higher in this group; lower starting doses are typically used
  • Children under 3: Haloperidol is not intended for this age group
🚑If you take too much

Taking too much haloperidol can cause severe drowsiness, low blood pressure, dangerous heart rhythm changes, and severe muscle rigidity or tremors. A person who has taken too much may appear unresponsive, with slowed breathing and signs of cardiovascular collapse.

If overdose is suspected, call 911 or poison control immediately. There is no specific antidote — treatment is supportive and aimed at stabilizing breathing, blood pressure, and heart rhythm. Heart monitoring is essential until the ECG returns to normal.

📡Pharmacodynamics — effects in the body

The full picture of how haloperidol's effects in the body relate to its dose and timing has not been completely worked out. What is known is that it blocks dopamine receptors in the brain, which is believed to underlie its antipsychotic effects. It also has activity at alpha-1 adrenergic receptors, and minimal activity at certain other receptor types, which may contribute to some of its other effects on the body.

🔬Pharmacokinetics — how your body processes it

Haloperidol is broken down by the liver through several pathways, with the CYP3A4 and CYP2D6 enzyme systems playing important roles. Because it is so extensively metabolized in the liver, people with liver problems may have higher drug levels than expected. Less than 3% of the drug leaves the body unchanged through the urine.

Older adults tend to clear haloperidol more slowly than younger people, which is why lower doses are recommended for this group. Drugs that block the CYP3A4 or CYP2D6 enzymes — like ketoconazole or paroxetine — can raise haloperidol levels meaningfully, increasing both the risk of side effects and the risk of QT prolongation.

📦How to store it

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) Protect from light.

📄 Written from Haloperidol’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 →

211

Supplements & herbs that interact with Haloperidol

211 supplements and herbal products have documented interactions with Haloperidol 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 · 11
  • Moderate · 157
  • Minor · 43
Every supplement checked against Haloperidol — ranked by severity The full interaction hub: 11 major · 157 moderate · 43 minor · every one linked to its full report. Check Haloperidol 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 Haloperidol — the kind of thing our pharmacy team would talk through with you at the counter.

What is haloperidol actually used for?
Haloperidol is mainly used to manage symptoms of psychotic disorders — things like hallucinations and severely disorganized thinking. It's also used to control the tics and vocal sounds of Tourette's disorder. In some children, it's prescribed for severe explosive behavior or significant hyperactivity with conduct problems, but only after other treatments haven't worked.
What side effects should I watch out for when I first start taking it?
The most common things people notice early on are muscle stiffness, tremors, or a restless, can't-sit-still feeling. Some people also feel drowsy or notice their blood pressure dipping when they stand up quickly. These movement side effects are real and common — if they're bothering you, don't just push through. Tell your doctor, because they can often adjust your dose or add a medication to help.
Is there anything serious I should call my doctor or go to the ER for?
Yes — a few things need prompt attention. If you develop sudden muscle spasms in your neck or jaw, throat tightening, or trouble swallowing or breathing, get help right away. Also seek immediate care for a high fever with severe muscle stiffness and confusion, or for an irregular or racing heartbeat with dizziness or fainting. And if you notice repetitive, uncontrolled movements — especially in your face or tongue — let your doctor know as soon as possible.
My grandmother has dementia — can haloperidol help with her behavior?
This is really important: haloperidol is not approved for dementia-related psychosis, and the FDA has placed a strong warning on it for this use. Studies have shown that elderly patients with dementia who take antipsychotic drugs have a significantly higher risk of death — from heart problems and infections like pneumonia. If your grandmother's doctor is considering this medication, please have a direct conversation about the risks before starting it.
Are there any medications I should avoid while taking haloperidol?
Yes — a few really matter. Other drugs that affect heart rhythm can combine with haloperidol to cause a dangerous arrhythmia, so make sure every doctor and pharmacist knows you're on it. The antifungal ketoconazole and the antidepressant paroxetine can both raise haloperidol levels in your blood, which increases side effect risk. Always bring a full list of your medications — including over-the-counter drugs and supplements — to every appointment.
What is tardive dyskinesia, and should I be worried about it?
Tardive dyskinesia is a condition where you develop repetitive, uncontrolled movements — often in the face, tongue, or limbs — from long-term use of antipsychotic medications. The tricky part is that it can sometimes become permanent, even after stopping the drug, and there's no established cure. The risk goes up the longer you take the medication and the higher the total dose. This is why your doctor aims to use the lowest effective dose for the shortest time needed — and why regular check-ins are important.
Is Haloperidol available over the counter?
Haloperidol is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Haloperidol first available?
Haloperidol has been available in the United States since at least 1967, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Haloperidol?
Haloperidol is supplied by 65 manufacturers listed in the FDA NDC Directory, including Remedyrepack Inc., Bryant Ranch Prepack, Zydus Pharmaceuticals USA Inc..

💬 Answers drafted from Haloperidol’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 Haloperidol comes

Haloperidol is available in 3 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.

Oral solution

By mouth
Available strengths 1 strength
9 FDA-listed product records

📊 Haloperidol across the U.S. market

How Haloperidol 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.

3
Dose forms
65
Manufacturers
4
Brand names
502
FDA-listed product records
1967
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 (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Remedyrepack Inc.12%
Bryant Ranch Prepack10%
Zydus Pharmaceuticals USA Inc.7%
Upsher-Smith Laboratories, LLC5%
Method Pharmaceuticals, LLC5%
Zydus Lifesciences Limited5%
Other makers57%

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

📈 How widely Haloperidol is used

A general measure of how commonly Haloperidol 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 Haloperidol 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.

821,226
Medicaid prescriptions filled (Q1–Q4 2025)
$19.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Haloperidol prescribed? Of the 1,596 medications we measure, Haloperidol ranks #197 by Medicaid prescriptions — more than 88% of them.

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

Utilization by Haloperidol 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 5 mg oral tablet is the most-dispensed Haloperidol product — about 30% of these Medicaid prescriptions.

haloperidol 5 MG Oral Tablet Most dispensed

250,395 Medicaid prescriptions (Q1–Q4 2025) 30% of Haloperidol prescriptions shown $4.7M gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 13 of 73 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310672

1 ML haloperidol decanoate 100 MG/ML Injection

179,954 Medicaid prescriptions (Q1–Q4 2025) 22% of Haloperidol prescriptions shown $6.3M gross reimbursement (before rebates) ≈ $35 per prescription (gross)

Summed across the 21 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719803

haloperidol 10 MG Oral Tablet

171,701 Medicaid prescriptions (Q1–Q4 2025) 21% of Haloperidol prescriptions shown $3.6M gross reimbursement (before rebates) ≈ $21 per prescription (gross)

Summed across the 9 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314035

haloperidol 2 MG Oral Tablet

67,011 Medicaid prescriptions (Q1–Q4 2025) 8% of Haloperidol prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 9 of 53 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314034

1 ML haloperidol 5 MG/ML Injection

36,357 Medicaid prescriptions (Q1–Q4 2025) 4% of Haloperidol prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $35 per prescription (gross)

Summed across the 3 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719646

haloperidol 1 MG Oral Tablet

34,503 Medicaid prescriptions (Q1–Q4 2025) 4% of Haloperidol prescriptions shown $560,841 gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 9 of 55 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310671

1 ML haloperidol decanoate 50 MG/ML Injection

29,863 Medicaid prescriptions (Q1–Q4 2025) 4% of Haloperidol prescriptions shown $698,663 gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 16 of 40 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719862

haloperidol 20 MG Oral Tablet

22,786 Medicaid prescriptions (Q1–Q4 2025) 3% of Haloperidol prescriptions shown $672,657 gross reimbursement (before rebates) ≈ $30 per prescription (gross)

Summed across the 6 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197754

haloperidol 0.5 MG Oral Tablet

16,279 Medicaid prescriptions (Q1–Q4 2025) 2% of Haloperidol prescriptions shown $206,813 gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 9 of 48 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310670

haloperidol 2 MG/ML Oral Solution

7,744 Medicaid prescriptions (Q1–Q4 2025) <1% of Haloperidol prescriptions shown $315,772 gross reimbursement (before rebates) ≈ $41 per prescription (gross)

Summed across the 7 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 141935

haloperidol decanoate 100 MG/ML Injectable Solution

4,382 Medicaid prescriptions (Q1–Q4 2025) <1% of Haloperidol prescriptions shown $292,269 gross reimbursement (before rebates) ≈ $67 per prescription (gross)

Summed across the 5 of 31 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859871

haloperidol 5 MG/ML Injectable Solution

251 Medicaid prescriptions (Q1–Q4 2025) <1% of Haloperidol prescriptions shown $980 gross reimbursement (before rebates) ≈ $3.90 per prescription (gross)

Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 204416

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 Haloperidol, 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 109 of 470 listed Haloperidol NDCs with Medicaid activity.

🔍 Compare Haloperidol products

A representative set of FDA-listed product records for Haloperidol — 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 502 products — FDA National Drug Code Directory. See every product, package size and price: browse all 502 Haloperidol 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) Haloperidol RxCUI 5093 6 dose forms · 21 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 372375 In current FDA listings
    Clinical drug / strength (SCD) decanoate 100 MG/ML RxCUI 859871 decanoate 50 MG/ML RxCUI 859867 5 MG/ML RxCUI 204416 10 MG/ML RxCUI 199953
  2. Dose form (SCDF) Oral Capsule RxCUI 376237 No current FDA listing
    Clinical drug / strength (SCD) 0.5 MG RxCUI 249960
  3. Dose form (SCDF) Oral Solution RxCUI 372376 In current FDA listings
    Clinical drug / strength (SCD) 0.2 MG/ML RxCUI 108873 0.3 MG/ML RxCUI 108375 0.4 MG/ML RxCUI 108872 1 MG/ML RxCUI 310673 2 MG/ML RxCUI 141935
  4. Dose form (SCDF) Oral Tablet RxCUI 372377 In current FDA listings
    Clinical drug / strength (SCD) 0.5 MG RxCUI 310670 1 MG RxCUI 310671 1.5 MG RxCUI 199319 2 MG RxCUI 314034 5 MG RxCUI 310672 10 MG RxCUI 314035 20 MG RxCUI 197754
  5. Dose form (SCDF) Prefilled Syringe RxCUI 1876501 No current FDA listing
    Clinical drug / strength (SCD) 1 ML haloperidol 5 MG/ML RxCUI 1876502

Look up RxCUI 5093 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

Haldol Haloperidol Decanoate Haloperidol Lactate Haldol Decanoate

🏭 Manufacturers & labelers

Remedyrepack Inc. 56 Bryant Ranch Prepack 45 Zydus Pharmaceuticals USA Inc. 31 Upsher-Smith Laboratories, LLC 24 Method Pharmaceuticals, LLC 24 Zydus Lifesciences Limited 23 Innogenix, Inc. 18 Major Pharmaceuticals 18 Mylan Pharmaceuticals Inc. 17 Somerset Therapeutics, LLC 15 Lifestar Pharma LLC 14 Novadoz Pharmaceuticals LLC 12 Marlex Pharmaceuticals, Inc. 12 Hikma Pharmaceuticals USA Inc. 11 Cardinal Health 107, LLC 10 Coupler LLC 10 Mylan Institutional Inc. 9 Gland Pharma Limited 9 BluePoint Laboratories 8 Sagent Pharmaceuticals 7 Mylan Institutional LLC 7 American Health Packaging 7 Amici Pharmaceuticals, LLC 6 Meitheal Pharmaceuticals Inc. 6

…and 16 more on the FDA NDC directory.

RxNorm drug class

Haloperidol belongs to the Typical Antipsychotic class.

Pharmacologic class Typical Antipsychotic
Drug family (ATC) Butyrophenone derivatives

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 Nov 15, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Haloperidol.
📈
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 Haloperidol after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
80
NDC products indexed
502
Distinct labelers/manufacturers represented
65
Linked representative label
Lifestar Pharma LLC
Linked label effective
Nov 15, 2024
Composite sections available
15
Linked SPL Set ID
00bb61c8-db35-4c04-9ef7-47d447d2496b
Linked SPL Document ID
7b545974-2d39-4106-8975-76c124a6c5ee
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 80 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. Lifestar Pharma LLC 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.