Prescription medicine
Flavoxate First approved as Urispas
Flavoxate (Urispas) is a prescription medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $0.389 per flavoxate HCl 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the flavoxate FDA label on DailyMed (effective December 27, 2023, Epic Pharma, LLC); the NDA 16769 record on Drugs@FDA; every flavoxate label on DailyMed.
Highlights of the record
FDA label of December 27, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFlavoxate 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.
Forms and strengths
- 100 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- January 15, 1970 Urispas, Ortho Mcneil Janssen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first August 28, 2003; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.389 per tablet Flavoxate HCl 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 101 through July 30, 2026
What is flavoxate used for?
From the label: indications and usageFlavoxate 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.
Conditions named in the indications of flavoxate's FDA labels, with every medicine labeled for each:
From other flavoxate labelsPain: 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 …
FDA pharmacologic class: Cholinergic Muscarinic Antagonist.
Source: FDA drug label (Flavoxate Hydrochloride), Epic Pharma, LLC, effective December 27, 2023 (SPL set b4260d7e-2ab3-49f6-aa57-bae19a23d82a), via openFDA; the full label on DailyMed
Is there a generic for flavoxate (Urispas)?
The FDA approved the first generic flavoxate on August 28, 2003. 3 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists flavoxate from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1970 earliest approval on file
- 2003 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for flavoxate (Urispas)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.389 per Flavoxate HCl 100 mg tablet, down 52% from $0.814 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Flavoxate HCl 100 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Flavoxate HCl 100 mg tablet | Generic | $0.389 per tablet | $11.68 | -52% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for flavoxate?
The FDA Adverse Event Reporting System holds 101 reports that list flavoxate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 57 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as flavoxate?
34 other medicines are given the same way (oral) and in the same FDA class as flavoxate or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Aspirin | Pain | none listed | $0.0142 per tablet 81 mg tablet | A presentation being discontinued |
| Acetaminophen and hydrocodone | Pain | 38 labelers | $0.152 per tablet 10-325 mg tablet | No current entry |
| Diclofenac | Pain | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Acetaminophen and oxycodone | Pain | 30 labelers | $0.183 per tablet 7.5-325 mg tablet | A presentation being discontinued |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
| Morphine | Pain | 17 labelers | $0.226 per tablet 15 mg tablet | In shortage |
| Phenazopyridine | Pain | none listed | $0.154 per tablet 100 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other cholinergic muscarinic antagonists
- the pharmacologic class, with prices and generics
- Flavoxate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other