Flavoxate Hydrochloride 100 mg Tablet, 100-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Cholinergic Muscarinic Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Flavoxate is used to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) relieve painful, frequent, or nighttime urination and urgency that may occur with infections of the prostate, bladder, or kidneys. Flavoxate is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles. However, flavoxate is not an antibiotic; it does not cure infections.
Read the full MedlinePlus article ↗- No — and that's an important distinction. Flavoxate is a symptom reliever, not an antibiotic. It helps calm the spasms in your urinary tract that cause the burning, urgency, and fr...
- Will flavoxate actually cure my bladder infection?
- In a clinical study, flavoxate started working in about 55 minutes, with the strongest effect hitting around the 112-minute mark — so roughly two hours after your dose. You likely...
- How long does it take for flavoxate to start working?
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
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UNII 1IVH67816N
Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII VH2XOU12IE
Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.398 | $39.82 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.6307 | $63.07 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.9602 | $96.02 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Flavoxate Hydrochloride 100 mg 00574-0115-01 | Padagis | 100 tablets | $0.398 | AB | Availability likely | — |
| Flavoxate Hydrochloride 100 mgthis 42806-0058-01 | Epic | 100 tablets | $0.398 | AB | Availability likely | — |
| Flavoxate Hydrochloride 100 mg 24658-0720-01 | PuraCap | 100 tablets | $0.547 | AB | FDA listed | +37% |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 42806-0058-01 You're viewing this | 100 TABLET in 1 BOTTLE (42806-058-01) | $0.3982 / ea | $39.82 | 2011-02-21 | Active |
| 42806-0058-10 | 1000 TABLET in 1 BOTTLE (42806-058-10) | — | — | 2011-02-21 | Active |
You're viewing the smallest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 42806-0058-01?
What is the difference between NDC 42806-0058-01 and NDC 42806-0058-10?
What NDC number is used to bill for this package of Flavoxate Hydrochloride 100 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Flavoxate hydrochloride tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Adults and children over 12 years of age One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.
⛔ Contraindications ▾
CONTRAINDICATIONS Flavoxate hydrochloride is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.
⚠️ Warnings ▾
WARNINGS Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Gastrointestinal: Nausea, vomiting, dry mouth. CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.
Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug). Cardiovascular: Tachycardia and palpitation. Allergic : Urticaria and other dermatoses, eosinophilia and hyperpyrexia.
Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation. Renal: Dysuria.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects-Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate hydrochloride. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in children below the age of 12 years have not been established.
🆘 Overdosage ▾
OVERDOSAGE The oral LD 50 for flavoxate hydrochloride in rats is 4273 mg/kg. The oral LD 50 for flavoxate hydrochloride in mice is 1837 mg/kg. It is not known whether flavoxate hydrochloride is dialyzable.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle. In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the flavoxate hydrochloride was excreted in the urine within 24 hours.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ Є58 ” on one side and plain on the other side, and are available as follows: NDC 42806-058-01 Bottles of 100 NDC 42806-058-10 Bottles of 1000 Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container. Distributed by Epic Pharma, LLC Laurelton, NY 11413 Rev.
07-2023-00 MF058REV07/23 OE1140
📋 Description ▾
DESCRIPTION Flavoxate hydrochloride tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic. Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4 H -1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C 24 H 25 NO 4 •HCl.
The molecular weight is 427.94. The structural formula appears below. Each tablet for oral administration contains 100 mg flavoxate hydrochloride.
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin. Structure Formula
💬 Information for Patients ▾
Information for Patients Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.