FDA-filed SPL labeling · retrieved through openFDA

Tolterodine

Tolterodine is an antimuscarinic medicine used to treat overactive bladder — including the urge to urinate frequently, sudden strong urges, and urge-related leakage.

Brand names DetrolDetrol LATolterodine Tartarate
Drug class ⓘ Cholinergic Muscarinic Antagonists
Rx Forms 4 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 25 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 25, 2025
Clinical labels in scope ⓘ25
AvailabilityRx
Earliest approval/marketing year ⓘ1998
FDA-listed product records ⓘ122
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 23, 2026
⭐ Tolterodine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Tolterodine is a well-established prescription treatment for overactive bladder that helps reduce urgency, frequent urination, and leakage. Dry mouth is the most common complaint, but most people tolerate it well. Take it exactly as prescribed, and let your doctor know about all other medications you use — especially strong antifungals or antibiotics — since some can raise tolterodine levels in your body.
How we write & review this content — our editorial policy →

📖 Tolterodine: Patient Information Guide

A plain-language walkthrough of Tolterodine — 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▾

Tolterodine is approved across all its available forms to treat overactive bladder.

  • Urge urinary incontinence — leaking urine when a sudden urge strikes
  • Urgency — a sudden, strong need to urinate that is hard to delay
  • Urinary frequency — urinating more often than normal

Detrol and Tolterodine Tartrate tablets, as well as Detrol LA and Tolterodine Tartrate extended-release capsules, are all approved for this same set of symptoms. No other uses are listed in the prescribing information for any of these products.

⚙️How it works▾

Tolterodine works by blocking muscarinic receptors — the docking sites that the chemical messenger acetylcholine uses to trigger bladder contractions. By blocking these receptors, tolterodine reduces the overactive squeezing of the bladder that causes urgency, frequency, and leakage. The liver converts tolterodine into an active metabolite (called 5-HMT) that carries much of the therapeutic effect. Both the original drug and 5-HMT are highly selective for muscarinic receptors and have little activity at other receptor types.

About 7% of Caucasians and about 2% of African Americans process tolterodine more slowly (called poor metabolizers) because of a genetic difference in the CYP2D6 enzyme. In these individuals, tolterodine levels run higher and 5-HMT levels are lower — which can influence both effectiveness and side effect risk. Prescribers may account for this when selecting a dose.

💊How it's taken▾

Tolterodine comes as immediate-release tablets taken twice daily and as extended-release capsules taken once daily. Extended-release capsules should be swallowed whole with water — never crushed or chewed. Food does not affect the absorption of the extended-release capsule, so it can be taken at any time. Tablets may be taken with or without food as well, though food does increase absorption somewhat — this is not considered a safety concern and no dose change is needed.

  • Always follow your prescriber's exact directions; doses may be adjusted based on how well your kidneys and liver are working or other medications you take
  • If you miss a dose, follow the guidance on your label or ask your pharmacist — do not double up
🤒Side effects — in detail▾

The most common side effects of tolterodine are typical of medicines that work by blocking muscarinic receptors:

  • Dry mouth (most frequently reported — affects about 1 in 3 people taking the tablet form)
  • Constipation
  • Headache
  • Dizziness or vertigo
  • Abdominal pain
  • Blurred vision or trouble focusing (accommodation abnormalities)
  • Dry eyes (xerophthalmia)
  • Drowsiness
  • Indigestion (dyspepsia)

Serious reactions — including severe allergic reactions (anaphylaxis, angioedema with throat swelling), inability to urinate, confusion, hallucinations, or a fast/irregular heartbeat — require immediate medical attention. These are less common but have been reported in post-marketing use.

⚠️Warnings & precautions▾
  • Severe allergic reactions: Anaphylaxis and angioedema (life-threatening airway swelling) have occurred — even after the first dose. Stop tolterodine and seek emergency care if you have trouble breathing, throat tightening, or a sudden blood pressure drop.
  • Urinary retention: Tolterodine can make it harder to empty your bladder. Use with extra caution if you already have a bladder outflow obstruction.
  • Stomach and bowel slowing: Like all antimuscarinics, tolterodine slows gut movement. It should be used carefully in people with GI blockages or conditions like intestinal atony (a poorly moving bowel).
  • Drowsiness and brain effects: Tolterodine can cause dizziness, drowsiness, confusion, and disorientation — especially early in treatment or after a dose increase. Avoid driving or operating machinery until you know how it affects you.
  • Heart rhythm (QT prolongation): At higher-than-recommended exposures, tolterodine can lengthen the QT interval (a measure of heart electrical activity). People with a known history of QT prolongation or those on certain heart-rhythm drugs need special consideration.
  • Narrow-angle glaucoma: Tolterodine is contraindicated in uncontrolled narrow-angle glaucoma and should be used with caution even in treated cases.
  • Liver and kidney disease: Both conditions slow how tolterodine is cleared — lower doses are required for moderate liver or severe kidney impairment, and the extended-release capsule is not recommended at all in severe liver disease or very low kidney function.
🔀What it interacts with▾

Several medications can change how tolterodine works in your body, or make its side effects worse:

  • Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir) — these raise tolterodine blood levels significantly; a lower dose of the extended-release capsule is recommended when any of these are used together
  • Fluoxetine (CYP2D6 inhibitor) — changes how tolterodine is broken down, but the overall active drug level rises only modestly; no dose change needed, but your doctor should know
  • Other anticholinergic (antimuscarinic) drugs — combining them with tolterodine stacks up the anticholinergic effects, worsening dry mouth, constipation, blurred vision, and drowsiness
  • Warfarin, oral contraceptives, and diuretics — no clinically meaningful interaction was found in studies; these can generally be used together without special precautions related to tolterodine

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▾
  • Do not take if you have urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma — these are absolute contraindications
  • Do not take if you are allergic to tolterodine, any of its ingredients, or to fesoterodine fumarate extended-release tablets (it converts to the same active form in the body)
  • Liver disease: If you have mild to moderate liver impairment, a lower dose is used; the extended-release capsule should not be used in severe liver disease
  • Kidney disease: If you have severe kidney impairment, a lower dose is needed; the extended-release capsule is not recommended when kidney function is very low
  • Bladder or bowel obstruction: Tell your doctor if you have any blockage in your urinary or digestive tract, or a condition that slows gut movement
  • Narrow-angle glaucoma being treated: Use with caution and only under close medical supervision
  • Myasthenia gravis (a nerve-muscle disorder causing weakness): use with caution
  • Heart rhythm problems: Tell your doctor if you have a history of prolonged QT interval or take antiarrhythmic medications such as quinidine, procainamide, amiodarone, or sotalol
  • Older adults and those with dementia: Post-marketing reports describe worsening confusion and disorientation, especially in patients taking cholinesterase inhibitors for dementia — discuss risks carefully with your doctor
🚑If you take too much▾

Taking too much tolterodine can cause severe anticholinergic effects — things like extreme dry mouth, inability to urinate, confusion, fast heart rate, and blurred vision. Heart rhythm monitoring (an ECG) is recommended if an overdose occurs. In a reported case, a young child who accidentally swallowed several tablets was treated with activated charcoal, observed overnight, and fully recovered.

📡Pharmacodynamics — effects in the body▾

Tolterodine's most measurable effect is on the bladder: it increases the amount of urine left after urinating (residual urine) and reduces the pressure the bladder muscle generates during filling. These effects reflect its antimuscarinic action on the lower urinary tract — calming an overactive bladder rather than fully suppressing normal bladder function. At doses higher than the recommended therapeutic range, tolterodine can also lengthen the QT interval on an ECG (a measure of heart electrical recovery time), and this effect correlates with how much tolterodine is in the bloodstream.

🔬Pharmacokinetics — how your body processes it▾

Tolterodine is well absorbed after oral dosing and is extensively processed by the liver into its main active form, 5-HMT. The extended-release capsule releases the drug slowly, reaching peak blood levels 2 to 6 hours after a dose, while the tablet form peaks within 1 to 2 hours. About 7% of Caucasians and 2% of African Americans carry a genetic variation that causes them to process tolterodine more slowly (via the CYP2D6 enzyme), leading to higher tolterodine levels and lower 5-HMT levels. Most of the drug and its breakdown products are eliminated in the urine over about 7 days.

📦How to store it▾

Tolterodine Tartrate Extended-release Capsules, USP are available containing 2 mg or 4 mg of tolterodine tartrate. Store at 25° (77°F); excursions permitted to 15° to 30°C (59 to 86°F) . Protect from light.

📄 Written from Tolterodine’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 →

178

Supplements & herbs that interact with Tolterodine

178 supplements and herbal products have documented interactions with Tolterodine 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 · 5
  • Moderate · 130
  • Minor · 43
ACTIVATED CHARCOAL Major GRAPEFRUIT Major HENBANE Major SCOPOLIA Major ST. JOHN'S WORT Major 1,3-DMAA Moderate ACACIA RIGIDULA Moderate ACTIVE HEXOSE CORRELATED COMPOUND (AHCC) Moderate +170 more
Every supplement checked against Tolterodine — ranked by severity The full interaction hub: 5 major · 130 moderate · 43 minor · every one linked to its full report. Check Tolterodine 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 Tolterodine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does tolterodine do, and how quickly will I notice a difference? ▾
Tolterodine calms the bladder by blocking the nerve signals that cause it to squeeze too often or too urgently. Most people start noticing fewer urgent trips to the bathroom and less leakage within the first few weeks of treatment. It won't be instant, so give it a fair trial and check in with your doctor if nothing seems to be changing after a few weeks.
The dry mouth is really bothersome — is there anything I can do about it? ▾
Dry mouth is the most common complaint with tolterodine, and it happens because the same receptors that calm your bladder also affect your saliva glands. Sipping water frequently, sucking on sugar-free candy or gum, and staying well hydrated can help. If it's severe enough to interfere with eating or speaking, let your doctor know — they may adjust your dose.
Is it safe to drive while I'm taking this? ▾
Not until you know how tolterodine affects you personally. It can cause dizziness and drowsiness, especially when you first start or if the dose is increased. Once you've been on it for a bit and you feel alert and steady, driving is generally fine — but err on the side of caution at first and avoid heavy machinery until you're sure.
I take a few other medications. Are there any I should be worried about? ▾
The main ones to flag are strong antifungals like ketoconazole or itraconazole, and antibiotics like clarithromycin — these can raise tolterodine levels in your blood and may require a lower dose. Also mention any other bladder medications or anything your doctor may describe as an 'anticholinergic,' because combining them can amplify side effects like dry mouth and constipation. Warfarin, birth control pills, and common water pills are generally fine alongside tolterodine.
Are there any serious warning signs I should call my doctor or 911 about? ▾
Yes — and a couple of these are urgent. If you suddenly have trouble breathing, feel your throat swelling, or your blood pressure drops sharply, that's a potential severe allergic reaction — call 911 immediately. Also call your doctor promptly if you can't urinate at all, feel severely confused or disoriented, notice a rapid or fluttering heartbeat, or develop severe abdominal pain. These are uncommon but real risks worth knowing about.
I have some liver and kidney issues — can I still take tolterodine? ▾
Possibly, but your doctor will need to adjust things. If you have mild to moderate liver disease, a lower dose is typically used. Severe liver disease is a reason to avoid the extended-release capsule altogether. Similarly, if your kidneys are working poorly, a lower dose is recommended — and if your kidney function is very low, the extended-release capsule isn't recommended. Always make sure your prescriber knows your full kidney and liver history before starting.
Is Tolterodine available over the counter? ▾
Tolterodine 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 Tolterodine first available? ▾
Tolterodine has been available in the United States since at least 1998, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Tolterodine? ▾
Tolterodine is supplied by 36 manufacturers listed in the FDA NDC Directory, including Teva Pharmaceuticals USA, Inc., Slate Run Pharmaceuticals, LLC, Greenstone LLC.

💬 Answers drafted from Tolterodine’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

📊Tolterodine supplement interactions178 checked — ranked by severity 🌿Drug & Supplement CheckerTolterodine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Tolterodine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Tolterodine comes

Tolterodine is available in 4 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.

Extended-release capsule

By mouth
Brands Detrol LA
How this form is used
What it may be used for
  • Detrol LA capsules are indicated for overactive bladder with symptoms of urgency, urge urinary incontinence, and urinary frequency
  • Tolterodine Tartrate Extended Release capsules are indicated for overactive bladder with symptoms of urgency, urge urinary incontinence, and urinary frequency
Important instructions
  • Detrol LA and Tolterodine Tartrate extended-release capsules are taken once daily by mouth
  • Swallow the capsule whole with water — do not crush, chew, or open it
  • Food does not affect how the extended-release capsule works, so it can be taken with or without a meal
  • Patients with mild to moderate liver disease, severe kidney impairment, or who take strong CYP3A4 inhibitors should take a lower once-daily dose as directed by their prescriber
Available strengths 2 strengths
2 mg 4 mg
69 FDA-listed product records ⓘ

Tablet

By mouth
Brands Detrol Tolterodine Tartarate
How this form is used
What it may be used for
  • Detrol tablets are indicated for overactive bladder with symptoms of urgency, urge urinary incontinence, and urinary frequency
  • Tolterodine Tartrate tablets are indicated for overactive bladder with symptoms of urgency, urge urinary incontinence, and urinary frequency
Important instructions
  • Tablets are taken by mouth twice daily
  • Food can increase how much tolterodine your body absorbs from tablets, but no dose adjustment is needed
  • Follow your prescriber's directions for the exact schedule that is right for you
Available strengths 2 strengths
1 mg 2 mg
35 FDA-listed product records ⓘ

Capsule

By mouth
Available strengths 2 strengths
2 mg 4 mg
2 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Available strengths 2 strengths
1 mg 2 mg
2 FDA-listed product records ⓘ

📊 Tolterodine across the U.S. market

How Tolterodine 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.

4
Dose forms ⓘ
36
Manufacturers
5
Brand names
122
FDA-listed product records ⓘ
1998
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 (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Teva Pharmaceuticals USA, Inc.8%
Slate Run Pharmaceuticals, LLC7%
Greenstone LLC7%
Major Pharmaceuticals6%
Viatris Specialty LLC5%
American Health Packaging5%
Other makers63%

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

📈 How widely Tolterodine is used

A general measure of how commonly Tolterodine 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 Tolterodine 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.

61,080
Medicaid prescriptions filled (Q1–Q4 2025)
$2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tolterodine prescribed? Of the 1,596 medications we measure, Tolterodine ranks #595 by Medicaid prescriptions — more than 63% of them.

Where Tolterodine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #595 of 1,596
#590 Halobetasol Topical 62,734 Rx #591 Clomipramine 62,585 Rx #592 Sildenafil 61,941 Rx #593 Rilpivirine 61,411 Rx #594 Acetaminophen Rectal 61,212 Rx #595 Tolterodine 61,080 Rx #596 Dextromethorphan 60,739 Rx #597 Piperacillin and Tazob... 60,527 Rx #598 Piperacillin / Tazobac... 60,527 Rx #599 Canagliflozin 60,010 Rx #600 Miconazole Topical 59,616 Rx

Utilization by Tolterodine 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 4 mg 24 hr extended release oral capsule is the most-dispensed Tolterodine product — about 63% of these Medicaid prescriptions.

24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule Most dispensed

38,434 Medicaid prescriptions (Q1–Q4 2025) 63% of Tolterodine prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $32 per prescription (gross)

Summed across the 19 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855189

24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule

12,044 Medicaid prescriptions (Q1–Q4 2025) 20% of Tolterodine prescriptions shown $425,336 gross reimbursement (before rebates) ≈ $35 per prescription (gross)

Summed across the 14 of 44 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855182

tolterodine tartrate 2 MG Oral Tablet

8,676 Medicaid prescriptions (Q1–Q4 2025) 14% of Tolterodine prescriptions shown $284,591 gross reimbursement (before rebates) ≈ $33 per prescription (gross)

Summed across the 6 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855194

tolterodine tartrate 1 MG Oral Tablet

1,926 Medicaid prescriptions (Q1–Q4 2025) 3% of Tolterodine prescriptions shown $52,039 gross reimbursement (before rebates) ≈ $27 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 855178

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 Tolterodine, 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 44 of 158 listed Tolterodine NDCs with Medicaid activity.

🔍 Compare Tolterodine products

A representative set of FDA-listed product records for Tolterodine — 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 122 of 122 products — FDA National Drug Code Directory. See every product, package size and price: browse all 122 Tolterodine 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) Tolterodine RxCUI 119565 2 dose forms · 4 strengths
  2. Dose form (SCDF) Oral Tablet RxCUI 374164 In current FDA listings
    Clinical drug / strength (SCD) tartrate 1 MG RxCUI 855178 tartrate 2 MG RxCUI 855194

Look up RxCUI 119565 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

Detrol Detrol LA Tolterodine Tartarate

🏭 Manufacturers & labelers

Teva Pharmaceuticals USA, Inc. 10 Slate Run Pharmaceuticals, LLC 8 Greenstone LLC 8 Major Pharmaceuticals 7 Viatris Specialty LLC 6 American Health Packaging 6 ANI Pharmaceuticals, Inc. 6 Pharmacia & Upjohn Company LLC 5 Macleods Pharmaceuticals Limited 4 Unichem Pharmaceuticals (USA), Inc. 4 Torrent Pharmaceuticals Limited 4 Rising Pharma Holdings, Inc. 4 Pharmacia and Upjohn Company LLC 4 Mylan Pharmaceuticals Inc. 4 A-S Medication Solutions 4 Ajanta Pharma USA Inc. 4 Golden State Medical Supply, Inc. 4 Athem LLC 4 Camber Pharmaceuticals, Inc. 4 Viatris Pharmaceuticals LLC 2 Marlex Pharmaceuticals Inc 2 Drug Ocean LLC 2 Catalent Pharma Solutions, LLC 2 Remedyrepack Inc. 2

…and 12 more on the FDA NDC directory.

RxNorm drug class

Tolterodine belongs to the Cholinergic Muscarinic Antagonist class.

Pharmacologic class Cholinergic Muscarinic Antagonist
Drug family (ATC) Drugs for urinary frequency and incontinence
How it works Cholinergic Muscarinic Antagonists

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 25, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tolterodine.
📈
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 Tolterodine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
25
NDC products indexed
122
Distinct labelers/manufacturers represented
36
Linked representative label ⓘ
American Health Packaging
Linked label effective
Nov 25, 2025
Composite sections available
24
Linked SPL Set ID
8cd23ff7-71ba-4391-95bd-a3a7f347713d
Linked SPL Document ID
447233c1-c996-9569-e063-6294a90a30be
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 25 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. American Health Packaging 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.