Over-the-counter medicine
Phenazopyridine
Phenazopyridine is an over-the-counter medicine. No generic is listed; pharmacies paid $0.154 per phenazopyridine 100 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Over the counter
Check it at the source: the phenazopyridine FDA label on DailyMed (effective July 14, 2026); every phenazopyridine label on DailyMed.
Highlights of the record
FDA label of July 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePhenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.
Forms and strengths
- 99.5 mg
Tablet.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.154 per tablet Phenazopyridine 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2016 0 Class I among all firms' recalls; latest October 28, 2016; 2 more by firms not listed as its makers
- FAERS reports
- 4,284 through July 30, 2026
What is phenazopyridine used for?
From the label: indications and usagePhenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. […]
Conditions named in the indications of phenazopyridine's FDA labels, with every medicine labeled for each:
From other phenazopyridine labelsPain: INDICATIONS AND USAGE Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery …
Urinary tract infections: Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than …
Source: FDA drug label (PHENAZOPYRIDINE HYDROCHLORIDE), Genus Lifesciences Inc., effective July 14, 2026 (SPL set 991b3b97-9cea-4c48-90a4-ebff55417d98), via openFDA; the full label on DailyMed
Is there a generic for phenazopyridine?
No generic phenazopyridine is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for phenazopyridine?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.154 per Phenazopyridine 100 mg tablet, down 10% from $0.170 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Phenazopyridine 100 mg tablet (generic)
- Pyridium 200 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ft urinary pain rlf 95 mg tablet | Generic | $0.132 per tablet | $3.95 | +2% |
| Ft urinary pain rlf 99.5 mg tablet | Generic | $0.184 per tablet | $5.52 | +6% |
| Gnp urinary pain rlf 99.5 mg | Generic | $0.184 per unit | n/a | +6% |
| Phenazopyridine 100 mg tablet | Generic | $0.154 per tablet | $4.62 | -10% |
| Phenazopyridine 200 mg tablet | Generic | $0.176 per tablet | $5.28 | -0.8% |
| Phenazopyridine HCl 95 mg tablet | Generic | $0.132 per tablet | $3.95 | +2% |
| Urinary pain relief 95 mg tablet | Generic | $0.132 per tablet | $3.95 | +2% |
| Urinary pain relief 99.5 mg tablet | Generic | $0.184 per tablet | $5.52 | +6% |
| Uro-pain 95 mg tablet | Generic | $0.132 per tablet | $3.95 | +2% |
| Uro-pain 99.5 mg tablet | Generic | $0.184 per tablet | $5.52 | +6% |
| Pyridium 200 mg tablet | Brand | $5.46 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $163.89 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has phenazopyridine been recalled?
The FDA's Enforcement Report lists 6 recalls naming phenazopyridine since 2016: 0 Class I (the most serious), 6 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of phenazopyridine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 31, 2024 | Class II | RemedyRepack Inc. not a listed maker | Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg. |
| May 28, 2024 | Class II | Winder Laboratories, LLC not a listed maker | Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg. |
| October 28, 2016 | Class II | Nationwide Laboratories, LLC | CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. |
| October 24, 2016 | Class II | Burel Pharmaceuticals Inc | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for phenazopyridine?
The FDA Adverse Event Reporting System holds 4,284 reports that list phenazopyridine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 289 are coded as a death and 1,386 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.
Reports received each year
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 phenazopyridine?
34 other medicines are given the same way (oral) and in the same FDA class as phenazopyridine 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 |
| Etodolac | Pain | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does phenazopyridine compare with medicines for the same use?
2 side-by-side pages set phenazopyridine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Phenazopyridine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other