FDA-filed SPL labeling · retrieved through openFDA

Lithium

Lithium is a mood-stabilizing medication used to treat and prevent manic episodes in bipolar disorder.

Brand names LithobidEskalithEskalith CRLithium CarbonateLithium Phosphoricum +11 more
Drug class Mood Stabilizer
Rx/OTC Forms 5 Route 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 61 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 effectiveAug 31, 2026
Clinical labels in scope 61
AvailabilityRx/OTC
Earliest approval/marketing year 1970
FDA-listed product records 306
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Lithium at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Lithium is a well-established mood stabilizer used to treat and prevent manic episodes in bipolar disorder, approved for use in adults and children 7 and older. Because the difference between a therapeutic dose and a toxic one is very small, regular blood level monitoring is not optional — it is essential. Keep up with your lab appointments, stay hydrated, maintain a normal salt intake, and call your doctor right away if you notice tremor, confusion, or other unusual symptoms.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Lithium can reach toxic levels even at doses that are within the normal treatment range. This means the line between a helpful dose and a harmful one is very thin. Blood lithium levels must be checked regularly using a simple blood test — before starting therapy and throughout treatment. Early signs of too much lithium include tremor, nausea, confusion, and unsteady walking. If these appear, contact your doctor or seek emergency care immediately. Do not take more than prescribed, and do not let yourself become dehydrated.

Read the full warning on DailyMed →

📖 Lithium: Patient Information Guide

A plain-language walkthrough of Lithium — 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

Lithium is a mood-stabilizing medication with approved uses across several oral formulations for bipolar disorder.

  • Lithium Carbonate capsules and tablets treat acute manic episodes of bipolar disorder and are used as maintenance therapy to reduce the frequency and severity of future manic episodes.
  • Lithium Carbonate extended-release tablets (including Lithobid) treat manic episodes of bipolar disorder and provide ongoing maintenance to reduce episode frequency and intensity.
  • Lithium oral solution is approved as monotherapy for bipolar I disorder — both for acute manic and mixed episodes and for long-term maintenance — in patients 7 years and older.
  • All supported formulations have established safety and effectiveness in patients 7 years of age and older for acute and maintenance treatment of bipolar I disorder; use in children under 7 has not been established.
⚙️How it works

The exact way lithium stabilizes mood is not fully known. What the science does show is that lithium is completely absorbed in the gut, spreads throughout the body's water (it does not bind to proteins in the blood), and is not broken down by the liver at all. It is cleared entirely by the kidneys, which is why kidney health is so central to using this drug safely. Because lithium distributes into brain tissue slowly — sometimes taking up to 24 hours — effects on mood and the onset of toxicity symptoms may both be delayed.

💊How it's taken

Lithium is taken by mouth, available as immediate-release capsules and tablets, extended-release tablets, and an oral solution. Immediate-release forms reach peak blood levels within about 15 minutes to 3 hours of a dose; extended-release forms take 2 to 6 hours to peak, which makes the rise and fall in blood levels more gradual.

  • Dosing frequency depends on the specific form prescribed — follow your prescriber's exact schedule.
  • Blood lithium levels must be checked regularly, usually drawn 12 hours after the last dose, until levels are stable and then on an ongoing basis.
  • Dose adjustments are typically made based on blood level results, kidney function, and how you respond to treatment — never adjust the dose on your own.
  • If you miss a dose, ask your pharmacist or prescriber what to do — do not double up.
🤒Side effects — in detail

Lithium causes a range of side effects, some common and manageable, others that require prompt medical attention.

  • Fine hand tremor — very common, especially when starting treatment
  • Increased urination and thirst (polyuria and polydipsia)
  • Nausea, vomiting, or diarrhea
  • Fatigue or general discomfort
  • Dizziness
  • Decreased appetite
  • Rash or skin irritation
  • Blurry vision (more commonly reported in children)

Serious reactions — including confusion, muscle twitching, slurred speech, irregular heartbeat, signs of serotonin syndrome (agitation, high fever, rapid heart rate, stiff muscles), or sudden vision changes — require immediate medical attention. Do not wait to see if they pass.

⚠️Warnings & precautions
  • Lithium toxicity: The gap between a therapeutic and a toxic blood level is very narrow. Tremor, nausea, confusion, unsteady walking, and slurred speech are early warning signs. Severe toxicity can cause seizures, coma, and permanent brain damage. Dehydration, low sodium, fever, and certain drugs can all tip levels into the toxic range quickly.
  • Kidney effects: Long-term lithium use is associated with chronic kidney disease and a condition where the kidneys lose the ability to concentrate urine (nephrogenic diabetes insipidus). Kidney function must be monitored before and throughout treatment.
  • Thyroid and parathyroid effects: Lithium can cause both hypothyroidism and, less commonly, hyperthyroidism. It is also linked to elevated calcium levels (hypercalcemia) and overactive parathyroid glands with long-term use. Regular thyroid and calcium monitoring is required.
  • Brugada syndrome: Lithium can unmask a rare heart rhythm disorder. Tell your doctor immediately about unexplained fainting or palpitations, or a family history of sudden unexplained death before age 45.
  • Encephalopathic syndrome: Combining lithium with antipsychotic medications raises the risk of a serious neurological reaction that, in some cases, has led to irreversible brain damage. Monitor closely for cognitive changes.
  • Serotonin syndrome: A potentially life-threatening reaction can occur when lithium is combined with serotonergic drugs. Seek emergency care if symptoms develop.
🔀What it interacts with

Lithium interacts with a wide range of medications and substances — many of them commonly used — because its blood levels are so sensitive to changes in kidney function and sodium balance.

  • Diuretics (water pills): Can lower sodium and reduce lithium clearance, pushing levels dangerously high.
  • NSAIDs (ibuprofen, naproxen, etc.): Reduce kidney blood flow, decreasing how well lithium is cleared and raising blood levels.
  • ACE inhibitors and ARBs (renin-angiotensin system drugs): Increase steady-state lithium levels; frequent monitoring needed.
  • Antipsychotics: Increase risk of neurological toxicity ranging from movement problems to neuroleptic malignant syndrome.
  • Serotonergic drugs (SSRIs, SNRIs, MAOIs, tramadol, triptans, St. John's Wort, fentanyl, buspirone): Can trigger serotonin syndrome — a medical emergency.
  • Metronidazole (antibiotic): Reduces kidney clearance of lithium, raising blood levels.
  • SGLT2 inhibitors (certain diabetes medications): Can lower lithium levels, potentially reducing effectiveness.
  • Iodide preparations: Combining with lithium can cause hypothyroidism.
  • Calcium channel blockers: Can increase the risk of neurological side effects including tremor and ataxia.
  • Neuromuscular blocking agents: Lithium may prolong their effects, leading to prolonged muscle paralysis.

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
  • Kidney disease: Lithium is cleared entirely by the kidneys — impaired kidney function raises toxicity risk significantly. Lithium should not be used in severe renal impairment.
  • Pregnancy: Lithium may harm the fetus, including potential cardiac malformations with first-trimester exposure. If continued during pregnancy, blood levels must be closely monitored, and the dose may need to be lowered or stopped before delivery.
  • Breastfeeding: Not recommended — lithium passes into breast milk at levels that can cause toxicity in infants. If a woman chooses to breastfeed, the infant must be closely monitored.
  • Children under 7: Safety and effectiveness have not been established for this age group.
  • Older adults: More likely to have reduced kidney function; start at lower doses and monitor carefully.
  • History of heart rhythm problems or unexplained fainting: Lithium can unmask Brugada syndrome — a cardiology consult is recommended before starting if risk factors are present.
  • Low sodium diet or dehydration: Dramatically increases the risk of lithium toxicity; maintain normal salt intake and stay well hydrated.
  • Hypersensitivity: Do not take lithium if you have a known allergy to any inactive ingredient in the specific lithium product prescribed.
🚑If you take too much

Lithium levels above 1.5 mEq/L are considered toxic, and levels above 3 mEq/L can lead to seizures, coma, and irreversible brain damage. There is no specific antidote. If overdose is suspected, call the Poison Control Center at 1-800-222-1222 or go to the nearest emergency room immediately. In severe cases, hemodialysis (a kidney dialysis machine) is the most effective way to rapidly remove lithium from the body.

🔬Pharmacokinetics — how your body processes it

After taking lithium by mouth, it is completely absorbed in the upper gastrointestinal tract. Immediate-release forms reach peak blood levels in as little as 15 minutes to 3 hours; extended-release forms take 2 to 6 hours to peak. Lithium is not broken down by the liver at all — it is eliminated unchanged by the kidneys. About 80% of the lithium filtered by the kidneys is reabsorbed, and its half-life (the time it takes for half the drug to leave the body) is approximately 18 to 36 hours. In children, how quickly the body clears lithium depends significantly on body weight, so dosing for pediatric patients is adjusted accordingly.

📦How to store it

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

📄 Written from Lithium’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 →

189

Supplements & herbs that interact with Lithium

189 supplements and herbal products have documented interactions with Lithium 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 · 12
  • Moderate · 163
  • Minor · 14
Every supplement checked against Lithium — ranked by severity The full interaction hub: 12 major · 163 moderate · 14 minor · every one linked to its full report. Check Lithium 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.

1

Nutrient depletion considerations

Lithium has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Lithium nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. 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 Lithium — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is lithium used for?
Lithium is a mood stabilizer prescribed mainly for bipolar I disorder. It works for two main purposes: treating the acute manic or mixed episodes when they happen, and as long-term maintenance therapy to keep those episodes from coming back — or at least make them less severe when they do. It's approved for both adults and children as young as 7 years old.
How will I know if my lithium level is too high?
Early warning signs of too much lithium include a noticeable hand tremor, nausea, diarrhea, dizziness, feeling unsteady on your feet, or slurred speech. If you notice any of those, contact your doctor right away. More serious signs — confusion, muscle twitching, seizures — are a medical emergency. That's why regular blood tests to check your lithium level are so important; we want to catch any problem before it becomes serious.
Do I need to watch what I eat or drink while taking lithium?
Yes — and this is really important. Lithium levels in your blood are closely tied to how much sodium (salt) and water you have in your body. If you suddenly cut back on salt, sweat a lot, get sick with vomiting or diarrhea, or become dehydrated, your lithium level can spike into the danger zone. Aim to keep your salt intake fairly consistent from day to day, drink enough fluids, and call your doctor if you're dealing with a fever, prolonged diarrhea, or anything that makes you lose a lot of fluid.
Can I take ibuprofen or other over-the-counter pain relievers with lithium?
You need to be very careful here. Common over-the-counter pain relievers like ibuprofen (Advil, Motrin) and naproxen (Aleve) are NSAIDs, and they can reduce how well your kidneys clear lithium — which means your lithium level can climb higher than it should. Acetaminophen (Tylenol) is generally a safer choice for pain relief, but always check with your pharmacist or doctor before adding anything new, even something sold without a prescription.
Is it safe to take lithium during pregnancy?
This is a conversation you should have with your doctor as soon as possible if you're pregnant or thinking about becoming pregnant. Lithium can potentially affect the baby's heart, especially if taken in the first trimester, and toxicity in the newborn is also a concern close to delivery. That said, untreated bipolar disorder also carries real risks during pregnancy. If you stay on lithium during pregnancy, your blood levels will need to be monitored more closely, and the dose may be adjusted near your due date. Don't stop lithium on your own — talk to your prescriber.
Will lithium affect my kidneys or thyroid over time?
Long-term lithium use can affect both. The kidneys bear the brunt because they're responsible for clearing all of the lithium from your body — over time, this can cause changes in kidney function or a condition where the kidneys struggle to concentrate urine. Your doctor will check kidney function regularly. Lithium can also interfere with your thyroid gland, most often causing it to become underactive (hypothyroidism), though rarely it can go the other way. Thyroid function is also monitored routinely — and if your thyroid does slow down, it can usually be managed with a thyroid supplement.
Is Lithium available over the counter?
Both — Lithium 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 Lithium first available?
Lithium has been available in the United States since at least 1970, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Lithium?
Lithium is supplied by 51 manufacturers listed in the FDA NDC Directory, including Hahnemann Laboratories, INC., Remedyrepack Inc., Hikma Pharmaceuticals USA Inc..

💬 Answers drafted from Lithium’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 Lithium comes

Lithium is available in 5 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.

Capsule

By mouth
Brands Lithium Carbonate
How this form is used
What it may be used for
  • Lithium Carbonate capsules are used to treat manic episodes of bipolar disorder
  • Lithium Carbonate capsules are used as maintenance therapy to reduce the frequency and severity of manic episodes in bipolar disorder
  • Established for use in patients 7 years and older for acute manic or mixed episodes and maintenance of bipolar I disorder
Important instructions
  • Lithium Carbonate capsules are taken by mouth
  • Blood lithium levels should be checked regularly — typically drawn 12 hours after the last dose
  • Follow your prescriber's instructions on how often to take each dose; do not adjust the dose on your own
Available strengths 3 strengths
102 FDA-listed product records

Extended-release tablet

By mouth
Brands Lithium Carbonate Lithobid
How this form is used
What it may be used for
  • Lithium Carbonate extended-release tablets are indicated for the treatment of manic episodes of bipolar disorder
  • Lithium Carbonate extended-release tablets are used as maintenance therapy to reduce the frequency and intensity of manic episodes
  • Lithobid is an extended-release formulation of lithium carbonate used for the same bipolar disorder indications
Important instructions
  • Extended-release tablets are taken by mouth; the extended-release design means peak levels in the blood are reached more gradually (about 2 to 6 hours after a dose) compared to immediate-release forms
  • Blood lithium levels must be monitored regularly throughout treatment
  • Do not crush or split extended-release tablets unless your pharmacist or prescriber confirms it is safe to do so
Available strengths 2 strengths
63 FDA-listed product records

Tablet

By mouth
Brands Lithium Carbonate
How this form is used
What it may be used for
  • Lithium Carbonate tablets are indicated for the treatment of manic episodes of manic-depressive illness (bipolar disorder)
  • Lithium Carbonate tablets are used as maintenance therapy to prevent or reduce the intensity of subsequent manic episodes
Important instructions
  • Lithium Carbonate tablets are taken by mouth
  • Regular monitoring of blood lithium levels is required throughout treatment
  • Follow your prescriber's instructions on dose timing and frequency
Available strengths 4 strengths
26 FDA-listed product records

Oral solution

By mouth
Brands Lithium bromatum Lithium Carb
How this form is used
What it may be used for
  • Lithium oral solution is indicated as monotherapy for the treatment of acute manic and mixed episodes of bipolar I disorder in patients 7 years and older
  • Lithium oral solution is indicated for maintenance treatment of bipolar I disorder in patients 7 years and older
Important instructions
  • Lithium oral solution is taken by mouth
  • Serum lithium concentrations must be monitored regularly during treatment
  • Follow your prescriber's dosing schedule carefully — do not change the amount or timing without medical guidance
Available strengths 5 strengths
18 FDA-listed product records

📊 Lithium across the U.S. market

How Lithium 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.

5
Dose forms
51
Manufacturers
18
Brand names
306
FDA-listed product records
1970
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) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Hahnemann Laboratories, INC.27%
Remedyrepack Inc.16%
Hikma Pharmaceuticals USA Inc.8%
PD-Rx Pharmaceuticals, Inc.6%
Glenmark Pharmaceuticals Inc., USA5%
Bryant Ranch Prepack5%
Other makers34%

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

📈 How widely Lithium is used

A general measure of how commonly Lithium 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 Lithium 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.

1,098,757
Medicaid prescriptions filled (Q1–Q4 2025)
$18.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Lithium prescribed? Of the 1,596 medications we measure, Lithium ranks #163 by Medicaid prescriptions — more than 90% of them.

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

Utilization by Lithium 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.

Other Lithium products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

1,098,757 Medicaid prescriptions (Q1–Q4 2025) 100% of Lithium prescriptions shown $18.5M gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 36 of 491 listed NDC products with Medicaid activity.

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 Lithium, 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 36 of 491 listed Lithium NDCs with Medicaid activity.

🔍 Compare Lithium products

A representative set of FDA-listed product records for Lithium — 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 306 products — FDA National Drug Code Directory. See every product, package size and price: browse all 306 Lithium 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) Lithium RxCUI 6448 2 dose forms · 1 strength
  1. Dose form (SCDF) Oral Capsule RxCUI 846385 In current FDA listings
    Clinical drug / strength (SCD) orotate 5 MG RxCUI 846386
  2. Dose form (SCDF) Oral Solution RxCUI 440967 In current FDA listings

Look up RxCUI 6448 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

Lithobid Eskalith Eskalith CR Lithium Carbonate Lithium Phosphoricum Lithium carbonicum Lithium Bromatum Lithium Metallicum Lithium Muriaticum Lithium Sulphuratum Lithium Fluoratum Lithium Iodatum Lithium Oxydatum Lithium Carbonate ER Lithium Carbonate Lithium Carbonate Lithium Carb

🏭 Manufacturers & labelers

Hahnemann Laboratories, INC. 81 Remedyrepack Inc. 46 Hikma Pharmaceuticals USA Inc. 23 PD-Rx Pharmaceuticals, Inc. 17 Glenmark Pharmaceuticals Inc., USA 15 Bryant Ranch Prepack 14 A-S Medication Solutions 11 Alembic Pharmaceuticals Inc. 8 Alembic Pharmaceuticals Limited 8 American Health Packaging 6 Camber Pharmaceuticals, Inc. 6 Coupler LLC 4 PAI Holdings, LLC dba PAI Pharma 4 Boiron 4 Advagen Pharma Ltd 3 Mylan Pharmaceuticals Inc. 3 Washington Homeopathic Products 3 ANI Pharmaceuticals, Inc. 3 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 3 AvKARE 3 Rising Pharmaceuticals, Inc. 2 Rising Pharma Holdings, Inc. 2 Energique, Inc. 2 NCS HealthCare of KY, LLC dba Vangard Labs 2

…and 16 more on the FDA NDC directory.

RxNorm drug class

Lithium belongs to the Lithium class.

Drug family (ATC) Lithium

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 Aug 31, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Lithium.
📈
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 Lithium after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
61
NDC products indexed
306
Distinct labelers/manufacturers represented
51
Linked representative label
Remedyrepack Inc.
Linked label effective
Aug 31, 2026
Composite sections available
22
Linked SPL Set ID
be1346df-4a39-45e8-874b-e2a496847fd5
Linked SPL Document ID
5a5d5889-cbba-dc8e-e063-6294a90a623b
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 61 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. Remedyrepack 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.