Phenazopyridine
Phenazopyridine is a urinary pain reliever used to quickly ease the pain, burning, urgency, and frequency caused by irritation of the urinary tract.
🧬 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 132 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 →
Phenazopyridine is a short-term urinary pain reliever that passes into the urine and numbs the irritated lining of the bladder, easing burning, urgency and frequency, but it does not treat a UTI; it is an old standby, available as a generic and over the counter. It is usually well tolerated over a short course, and nearly everyone notices bright orange or red urine, which is expected. Bluish or grayish skin is a sign of methemoglobinemia (blood that cannot carry oxygen well) and needs emergency care. Stop after 2 days with an antibiotic, and skip it with kidney disease, severe liver disease or G-6-PD deficiency (a red blood cell enzyme disorder).
Clinical pearls
- Give any urine sample for a suspected UTI before your first dose, since the orange dye can color urine test strips.
- Take it with or after meals and a full glass of water to keep nausea and stomach upset down.
- Products like Azo-Standard are this same drug, so do not double up with a prescription bottle of phenazopyridine.
- Yellowing of the skin or eyes is not the expected dye effect; call your prescriber, since it can signal liver trouble.
Patient information guide A plain-language walkthrough of Phenazopyridine, written from its FDA label.
What Phenazopyridine is used for
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Phenazopyridine relieves the painful symptoms caused by irritation of the lower urinary tract lining. It does not cure infections — it only eases discomfort while the underlying cause is treated.
- Relief of urinary pain, burning, urgency, and frequent urination caused by a urinary tract infection (UTI)
- Symptom relief from urinary tract irritation caused by trauma, surgery, or endoscopic (camera-based) procedures
- Comfort relief during or after passage of medical instruments (sounds or catheters) through the urinary tract
- Cystex Max UTI Pain Relief: indicated for fast relief of urinary pain, burning, urgency, and frequency associated with UTIs
- GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet: indicated for relief of urinary pain, burning, urgency, and frequency associated with UTIs
- CVS Health Urinary Pain Relief and Kroger Urinary Pain Relief: indicated for fast relief of urinary pain, burning, urgency, and frequency associated with UTIs
How Phenazopyridine works
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Phenazopyridine is taken by mouth, but it works locally — in your urine. Once absorbed, it passes quickly into the urinary tract and acts as a topical analgesic (a local painkiller) on the lining of the urinary tract, dulling the pain signals right where the irritation is happening. The exact molecular mechanism is not fully understood. It can reduce or eliminate the need for stronger systemic pain medications, and it works alongside antibiotic therapy without interfering with it.
Phenazopyridine dosage
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Phenazopyridine tablets are taken by mouth, typically three times a day, with or after meals. Take each dose with a full glass of water. The drug should not be used for more than 2 days, particularly when taken alongside an antibiotic for a UTI — there is no evidence it provides added benefit beyond that point.
- Adults and children 12 and older: 3 times daily, with or after meals, for up to 2 days
- Children under 12: only use under a doctor's direction
- Stop use once your symptoms are under control, or sooner if your doctor advises
Dosing details from the FDA-approved label
From the Phenazopyridine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults (Rx phenazopyridine 100 mg tablets)
- Average adult dosage is two tablets 3 times a day after meals
- Maximum: When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, administration should not exceed 2 days
- Adults (Rx phenazopyridine 200 mg tablets)
- Average adult dosage is one tablet 3 times a day after meals
- Maximum: When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, administration should not exceed 2 days
- Adults (Uricalm)
- Swallow two (2) tablets with water after meals as needed up to 3 times daily for 2 days maximum
- Swallow whole
- Do not crush or chew
- Maximum: Do not use more than 12 tablets in 2 days
- Drink 6 to 8 eight glasses of water daily; for use by normally healthy adults only
- Persons under 18 years of age (Uricalm)
- Use only as directed by a doctor
- Adults and children 12 years and older (OTC urinary pain relief)
- Take 2 tablets 3 times daily with or after meals as needed for up to two days
- Maximum: Do not use for more than 2 days (12 tablets) without consulting a doctor
- Take with a full glass of water
- Children under 12 years (OTC urinary pain relief)
- Do not use without consulting a doctor
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION 100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals. 200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals. When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine Hydrochloride should not exceed 2 days.
Read the full Dosage and Administration section on DailyMed →
Phenazopyridine side effects
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The most commonly reported side effects of phenazopyridine include:
Common side effects
- Headache
- Nausea, vomiting, or diarrhea
- Rash or itching
- Orange or red discoloration of urine and other body fluids
- Skin discoloration
When to get medical help
- Call your doctor if you develop yellowing of the skin or eyes (jaundice) — this can signal liver problems
- Seek immediate help if you notice bluish or grayish skin discoloration, which can be a sign of methemoglobinemia (a blood oxygen problem)
- Contact a doctor if you have signs of a serious allergic reaction: rash, difficulty breathing, or severe swelling
- Get medical help right away if you develop signs of kidney problems: swelling, very little urine, or unusual fatigue
- Stop use and call your doctor if you develop visual disturbances or signs of meningitis (severe headache, stiff neck, sensitivity to light)
More serious reactions — including methemoglobinemia (a blood oxygen problem causing bluish skin), hemolytic anemia (red blood cell breakdown), liver toxicity, kidney toxicity, and aseptic meningitis (brain lining inflammation without infection) — have been reported, especially with overdose or in people with kidney or liver problems. Seek emergency care if you experience bluish or grayish skin, yellowing of the eyes or skin, extreme fatigue, or severe headache with stiff neck.
Phenazopyridine warnings and precautions
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- Cancer risk in animals: Animal studies have shown increased tumor rates with phenazopyridine. Human evidence is inconclusive, but this is one reason it is approved only for short-term use.
- Overdose risk: Taking too much — or using a normal dose with impaired kidneys — can cause methemoglobinemia (blood can't carry oxygen) and hemolytic anemia (red blood cell breakdown). These are medical emergencies.
- Kidney and liver toxicity: Renal and hepatic toxicity have been reported, usually linked to overdose or hypersensitivity. Do not use if you have kidney insufficiency or severe liver disease.
- Not a treatment for infection: This drug only masks symptoms. Using it without also treating the underlying cause can delay necessary care.
- G-6-PD deficiency: People with this red blood cell enzyme deficiency are at heightened risk of hemolytic anemia and should avoid this drug.
Phenazopyridine interactions
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Systematic drug interaction studies have not been conducted for phenazopyridine. The medical literature to date has not identified significant drug interactions. However, tell your doctor and pharmacist about all medications you take, especially if you have kidney or liver conditions that could affect how the drug is cleared.
- No specific clinically significant drug interactions have been reported in the available evidence
Interactions listed in the FDA-approved label
From the Phenazopyridine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Other drugs: The interaction of Phenazopyridine Hydrochloride with other drugs has not been studied in a systematic manner; the medical literature to date suggests that no significant interactions have been reported.
Read the label’s full interactions text
Drug Interactions The interaction of Phenazopyridine Hydrochloride with other drugs has not been studied in a systematic manner. However, the medical literature to date suggests that no significant interactions have been reported.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Phenazopyridine
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- Do not use if you have kidney insufficiency (the kidneys clear this drug, and buildup can be toxic)
- Do not use if you have severe liver disease or severe hepatitis
- Do not use if you have pyelonephritis of pregnancy (a serious kidney infection during pregnancy)
- Use with caution if you have stomach or gastrointestinal problems
- People with G-6-PD deficiency are at higher risk of hemolytic anemia with this drug
- Older adults are more likely to have reduced kidney function and may be at greater risk of toxic side effects
- Children under 12 should only use this medication under a doctor's direct guidance
- Do not use if you are allergic to phenazopyridine or any of its ingredients
Phenazopyridine overdose
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Taking more than recommended — or taking a normal dose when your kidneys aren't working well — can cause toxic levels to build up in your blood. The most serious result is methemoglobinemia, where your blood loses its ability to carry oxygen properly, causing bluish or grayish skin discoloration. Hemolytic anemia (breakdown of red blood cells) can also occur. If you suspect an overdose, seek emergency medical care immediately.
What Phenazopyridine does in the body
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Phenazopyridine acts as a local analgesic (painkiller) on the lining (mucosa) of the lower urinary tract after it is excreted into the urine. It relieves pain, burning, urgency, and frequency by acting directly on the tissue where the irritation is occurring, rather than working through the bloodstream like systemic pain relievers. This targeted action can reduce or eliminate the need for stronger oral or injectable pain medications.
How your body processes Phenazopyridine
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Phenazopyridine is taken orally and its full pharmacokinetic profile has not been formally characterized. It and its breakdown products (metabolites) are rapidly eliminated by the kidneys. In a small study of healthy individuals, about 90% of the daily dose appeared in the urine within 24 hours — roughly 41% as unchanged drug and 49% as metabolites.
How to store Phenazopyridine
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STORE at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Phenazopyridine
17 supplements and herbal products have documented interactions with Phenazopyridine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
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.
Phenazopyridine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Phenazopyridine — the kind of thing our pharmacy team would talk through with you at the counter.
Does phenazopyridine actually treat my UTI, or does it just help with the pain?
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Why is my urine turning orange or red? Should I be worried?
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How long can I take this medication?
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Are there any people who definitely should not take this?
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What side effects should I actually call the doctor about?
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Can I take this if I'm not sure I have a UTI?
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Is Phenazopyridine available over the counter?
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When was Phenazopyridine first available?
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Who makes Phenazopyridine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Phenazopyridine on HelloPharmacist
Phenazopyridine forms and strengths (how it comes)
Phenazopyridine is available in 1 form. 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.
Tablet
How this form is used
- Cystex Max UTI Pain Relief: fast relief from urinary pain, burning, urgency, and frequency associated with urinary tract infections
- GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet: relief from urinary pain, burning, urgency, and frequency associated with urinary tract infections
- CVS Health Urinary Pain Relief: fast relief from urinary pain, burning, urgency, and frequency associated with urinary tract infections
- Kroger Maximum Strength Urinary Pain Relief and Kroger Urinary Pain Relief: fast relief from urinary pain, burning, urgency, and frequency associated with urinary tract infections
- Adults and children 12 and older: take tablets 3 times daily with or after meals as needed, for up to 2 days; take with a full glass of water
- GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet: do not use for more than 2 days (12 tablets) without consulting a doctor
- Gencare-Urinary Pain Relief Maximum Strength: children under 12 should not use without consulting a doctor
- Cystex Max UTI Pain Relief: treatment should not exceed 2 days without consulting a doctor
Phenazopyridine on the U.S. market: products, makers and brands
How Phenazopyridine 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.
56 companies list 114 Phenazopyridine product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1990. Brand names on the directory include Azo-Standard, Baridium, Nefrecil and 13 more; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (4) · Granule (1) · Kit (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Phenazopyridine is used (Medicaid data)
A general measure of how commonly Phenazopyridine 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 Phenazopyridine 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.
How commonly is Phenazopyridine prescribed? Of the 1,601 medications we measure, Phenazopyridine ranks #265 by Medicaid prescriptions — more than 83% of them.
Utilization by Phenazopyridine 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.
phenazopyridine hydrochloride 200 MG Oral Tablet Most dispensed
Summed across the 6 of 281 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1094104
phenazopyridine hydrochloride 100 MG Oral Tablet
Summed across the 4 of 222 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1094107
phenazopyridine hydrochloride 95 MG Oral Tablet
Summed across the 4 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1094126
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 Phenazopyridine, 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 14 of 544 listed Phenazopyridine NDCs with Medicaid activity.
Compare Phenazopyridine products
A representative set of FDA-listed product records for Phenazopyridine — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 100 mg | Oral | A-S Medication Solutions × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | A-S Medication Solutions × 4 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Advanced Rx LLC | UNAPPROVED DRUG OTHER | View NDC → |
| 95 mg | Oral | AmerisourceBergen Drug Corp | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | AmerisourceBergen Drug Corp | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | Amneal Pharmaceuticals LLC | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | Amneal Pharmaceuticals LLC | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Bonafide Health, LLC dba Uqora | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | Bryant Ranch Prepack × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | Bryant Ranch Prepack × 3 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Cadence Health | UNAPPROVED DRUG OTHER | View NDC → |
| 95 mg | Oral | Cardinal Health | UNAPPROVED DRUG OTHER | View NDC → |
| 97.5 mg | Oral | Cardinal Health | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Cardinal Health | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Chain Drug Consortium, LLC | UNAPPROVED DRUG OTHER | View NDC → |
| 95 mg | Oral | Chain Drug Marketing Association × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Chain Drug Marketing Association × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | Chartwell RX, LLC | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | Chartwell RX, LLC | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Clarion Brands, LLC | OTC MONOGRAPH DRUG | View NDC → |
| 99.5 mg | Oral | Cvs Pharmacy Inc | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | Direct Rx | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | Direct_Rx | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Discount Drug Mart, Inc | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Dolgencorp, Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Family Dollar Services Inc | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | Genus Lifesciences Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | Genus Lifesciences Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Get Stix Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | GPT Pharmaceuticals Private Limited | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Harris T eeter, LLC | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | i-Health, Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Insight Pharmaceuticals LLC | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Ixxa, Inc | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Kroger Company | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Medtech Products Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Meijer Distribution Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | Northwind Health Company, LLC | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | Northwind Health Company, LLC | UNAPPROVED DRUG OTHER | View NDC → |
| 95 mg | Oral | NuCare Pharmaceuticals,Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | NuCare Pharmaceuticals, Inc. × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | NuCare Pharmaceuticals,Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | NuCare Pharmaceuticals,Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Nuvicare Llc | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | PD-Rx Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | PD-Rx Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Pioneer Life Sciences, LLC | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | Preferred Pharmaceuticals Inc | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Preferred Pharmaceuticals Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | Preferred Pharmaceuticals Inc. × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | Preferred Pharmaceuticals Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 95 mg | Oral | Proficient Rx LP | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | Proficient Rx LP × 3 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | Proficient Rx LP × 3 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | Redpharm Drug | UNAPPROVED DRUG OTHER | View NDC → |
| 95 mg | Oral | Reese Pharmaceutical Co × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Reese Pharmaceutical Co × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 100 mg | Oral | Remedyrepack Inc. × 3 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 200 mg | Oral | Remedyrepack Inc. × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Retail Business Services , LLC. | UNAPPROVED DRUG OTHER | View NDC → |
| 95 mg | Oral | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 95 mg | Oral | Rite Aid | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Rite Aid | UNAPPROVED DRUG OTHER | View NDC → |
| 95 mg | Oral | Rugby Laboratories | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Safeway | UNAPPROVED DRUG OTHER | View NDC → |
| 95 mg | Oral | Skopko | UNAPPROVED DRUG OTHER | View NDC → |
| 95 mg | Oral | Strategic Sourcing Services LLC × 3 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 99.5 mg | Oral | Strategic Sourcing Services LLC × 3 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 💊Kits | ||||
| — | — | Bonafide Health, LLC dba Uqora | UNAPPROVED DRUG OTHER | View NDC → |
Showing 94 of 114 products — FDA National Drug Code Directory. See every product, package size and price: browse all 114 Phenazopyridine NDCs →
Phenazopyridine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Phenazopyridine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Phenazopyridine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Phenazopyridine FDA approval history
How Phenazopyridine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Phenazopyridine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Phenazopyridine recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10, Lots: Lot#: 1142404 Exp. Date 02/27/2027 FDA record D-0545-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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.
RxCUI 8120 1 dose form · 7 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 373303In current FDA listingsClinical drug / strength (SCD) hydrochloride 100 MGRxCUI 1094107hydrochloride 150 MGRxCUI 1094351hydrochloride 200 MGRxCUI 1094104hydrochloride 95 MGRxCUI 1094126hydrochloride 97.2 MGRxCUI 1094160hydrochloride 97.5 MGRxCUI 1094357hydrochloride 99.5 MGRxCUI 1094147
Look up RxCUI 8120 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.
Phenazopyridine supply and shortage status
Whether Phenazopyridine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Phenazopyridine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 200 mg | $5.46 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Phenazopyridine brand names
Phenazopyridine is sold under 16 brand names in the FDA directory — Azo-Standard, Baridium, Nefrecil, Phenazodine and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Phenazopyridine: manufacturers and labelers
56 companies list Phenazopyridine products with the FDA. By number of product records, the largest are Proficient Rx LP, A-S Medication Solutions, Strategic Sourcing Services LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 32 more on the FDA NDC directory.
Phenazopyridine drug class (RxNorm)
Phenazopyridine belongs to the Other urologicals class.
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.
Sources for this Phenazopyridine page
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.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Amneal Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →