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Uricalm Maximum Strength Phenazopyridine Hydochloride 99.5 mg Tablet, Film Coated, 24-count — NDC 52389-0241-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Uricalm Maximum Strength Phenazopyridine Hydochloride 99.5 mg Tablet, Film Coated, 24-count — NDC 52389-241-24 (Billing 52389-0241-24)

by Kobayashi Healthcare International, Inc. · 1 BLISTER PACK in 1 CARTON / 24 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of 24 tablets of Uricalm Maximum Strength Phenazopyridine Hydochloride 99.5 mg Tablet, Film Coated from Kobayashi Healthcare International, Inc., marketed since Apr 2008 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 52389-0241-24
🏷️ FDA NDC (as labeled) 52389-241-24 billing pads the product segment with a zero
This package
Contains24-count Pack sizes3 compare ↓
Main listing for product 52389-241 · Also comes in: 24 tablets 52389-241-48 28 tablets 52389-241-28
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 52389-241-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
52389 labeler · 241 product · 24 package
Package marketed since
Apr 29, 2008
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0072959415242
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52389-241-24
Product NDC 52389-241
11-digit billing NDC 52389024124
RxCUI 1094147, 1094149
UNII 0EWG668W17
UPC 0072959415242
SPL Set ID 1d94b45c-ee0b-499d-aca2-e8cd8dd490d2
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-04-29
Route ORAL
Dosage form TABLET, FILM COATED
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1094147
Why two NDCs? The FDA registers this code as 52389-241-24 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 52389-0241-24. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other urologicals class.

Drug family (ATC) Other urologicals
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Phenazopyridine relieves urinary tract pain, burning, irritation, and discomfort, as well as urgent and frequent urination caused by urinary tract infections, surgery, injury, or examination procedures. However, phenazopyridine is not an antibiotic; it does not cure infections.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It only helps with the pain — it doesn't kill the bacteria causing the infection. Think of it as taking the edge off while your antibiotic does the real work. If you have a UTI, yo...
  • Does phenazopyridine actually treat my UTI, or does it just help with the pain?
  • That's completely expected with phenazopyridine — it's one of the most common things people notice. The drug itself has an orange-red dye, and it passes into your urine, which is w...
  • Why is my urine turning orange or red? Should I be worried?
📖 Read our full Phenazopyridine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 24 tablets 28 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
52389-0241-24 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 24 TABLET, FILM COATED in 1 BLISTER PACK 2008-04-29 — Active
52389-0241-28 52389-241-28 1 BLISTER PACK in 1 CARTON / 28 TABLET, FILM COATED in 1 BLISTER PACK 2014-02-20 — Active
52389-0241-48 52389-241-48 2 BLISTER PACK in 1 CARTON / 24 TABLET, FILM COATED in 1 BLISTER PACK 2021-10-18 — Active

Pack size FAQ

What quantity is in this package?
This is a 24-count package — 1 blister pack in 1 carton / 24 tablet, film coated in 1 blister pack.
How does this package differ from NDC 52389-0241-28?
Both are Uricalm Maximum Strength Phenazopyridine Hydochloride 99.5 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 24-count one, while NDC 52389-0241-28 is the 28 tablets package.
What NDC number is used to bill for this package of Uricalm Maximum Strength Phenazopyridine Hydochloride 99.5 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Neighbor Maximum Strength Urinary Pain Relief 99.5 mg 46122-0628-53 AmerisourceBergen 12 tablets $0.184 — Availability likely —
URO-PAIN Maximum Strength 99.5 mg 57237-0330-21 Rising 12 tablets $0.184 — Availability likely —
Leader Maximum Strength Urinary Pain Relief 99.5 mg 70000-0523-01 Cardinal 12 tablets $0.184 — Availability likely —
Foster and Thrive Maximum Strength Urinary Pain Relief 99.5 mg 70677-1230-01 Strategic 12 tablets $0.184 — Availability likely —
HealthMart Maximum Strength Urinary Pain Relief 99.5 mg 62011-0412-01 Strategic 12 tablets $0.186 — FDA listed —
Sunmark Maximum Strength Urinary Pain Relief 99.5 mg 70677-0078-01 Strategic 12 tablets $0.186 — FDA listed —
Wallgreens Maximum Strength Urinary Pain Relief 99.5 mg 00363-8455-12 Walgreens 12 tablets — — FDA listed —
Preferred Maximum Strength Urinary Pain Relief 99.5 mg 10956-0210-12 Reese 12 tablets — — FDA listed —
Vexia Maximum Strength Urinary Pain Relief 99.5 mg 10956-0703-24 Reese 24 tablets — — FDA listed —
Maximum Strength Urinary Pain Relief 99.5 mg 11673-0270-24 TARGET 24 tablets — — FDA listed —
Rite Aid Maximum Strength Urinary Pain Relief 99.5 mg 11822-3111-02 Rite 12 tablets — — FDA listed —
Signature Care Maximum Strength Urinary Pain Relief 99.5 mg 21130-0792-24 Safeway 24 tablets — — FDA listed —
Kroger Maximum Strength Urinary Pain Relief 99.5 mg 30142-0221-24 THE 24 tablets — — FDA listed —
Maximum Strength Urinary Pain Relief 99.5 mg 30142-0756-24 KROGER 24 tablets — — FDA listed —
TopCare Maximum Strength Urinary Pain Relief 99.5 mg 36800-0510-12 TOPCO 12 tablets — — FDA listed —
Meijer Maximum Strength Urinary Pain Relief 99.5 mg 41250-0342-12 Meijer 12 tablets — — FDA listed —
Walmart Maximum Strength Urinary Pain Relief 99.5 mg 49035-0297-12 Walmart 12 tablets — — FDA listed —
AZO Urinary Pain Relief Maximum Strength 99.5 mg 49973-0247-12 i-Health, 12 tablets — — FDA listed —
Phenazopyridine Hydrochloride 99.5 mg 50696-0003-01 GPT 25000 tablets — — FDA listed —
Uricalm Maximum Strength 99.5 mgthis 52389-0241-24 Kobayashi 24 tablets — — FDA listed —
Discount Drugmart Maximum Strength Urinary Pain Relief 99.5 mg 53943-0336-12 Discount 12 tablets — — FDA listed —
Family Dollar Maximum Strength Urinary Pain Relief 99.5 mg 55319-0211-12 Family 12 tablets — — FDA listed —
Dollar General Maximum Strength Urinary Pain Relief 99.5 mg 55910-0631-12 Dolgencorp, 12 tablets — — FDA listed —
Uristat Ultra 99.5 mg 63029-0105-12 Medtech 12 tablets — — FDA listed —
Monistat Maintain 99.5 mg 63736-0020-12 Insight 12 tablets — — FDA listed —
Quality Choice Maximum Strength Urinary Pain Relief 99.5 mg 63868-0297-12 Chain 12 tablets — — FDA listed —
Premier Value Maximum Strength Urinary Pain Relief 99.5 mg 68016-0129-12 Chain 12 tablets — — FDA listed —
Preferred Maximum Strength Urinary Pain Relief 99.5 mg 68788-7778-01 Preferred 12 tablets — — Discontinued —
Harris Teeter Maximum Strength Urinary Pain Relief 99.5 mg 69256-0767-12 Harris 12 tablets — — FDA listed —
Cystex Max UTI Pain Relief 99.5 mg 69693-0514-24 Clarion 24 tablets — — FDA listed —
CVS Maximum Strength Urinary Pain Relief 99.5 mg 69842-0713-12 CVS 12 tablets — — FDA listed —
RIGHT REMEDIES Maximum Strength Urinary Pain Relief 99.5 mg 70692-0163-39 Strive 72 tablets — — FDA listed —
GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet 99.5 mg 70692-0178-08 Strive 8 tablets — — FDA listed —
Care One Maximum Strength Urinary Pain Relief 99.5 mg 72476-0210-12 Retail 12 tablets — — FDA listed —
Uti Pain Relief 99.5 mg 73436-2441-02 Cadence 12 tablets — — FDA listed —
Urinary Pain Relief 99.5 mg 73581-0909-72 YYBA 72 tablets — — Discontinued —
Urinary Pain Relief 99.5 mg 73581-0919-12 YYBA 120 tablets — — FDA listed —
Uqora Maximum UTI Pain Relief 99.5 mg 73712-0114-12 Bonafide 12 tablets — — FDA listed —
Maximum Strength Urinary Pain Relief 99.5 mg 80513-0517-72 Advanced 72 tablets — — FDA listed —
Stix Maximum Strength Urinary Pain Relief 99.5 mg 80584-0113-24 Get 24 tablets — — FDA listed —
Cheeky Bonsai UTI Pain Relief 99.5 mg 81860-0113-24 IXXA, 24 tablets — — FDA listed —
Quality Choice Maximum Strength Urinary Pain Relief 99.5 mg 83324-0199-12 Chain 12 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2008
On the market since
Apr 2008
📍
2026
Currently FDA-listed
18 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color red
ShapeRound
ImprintALVA;1
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII TZ8Z31B35M
    Cochineal is a natural red colorant derived from insects, used to give medicines and supplements their red or pink appearance. It helps make tablets and capsules visually identifiable.
  • UNII 0MVO31Q3QS
    A fruit extract from cranberries used as a natural flavor and coloring agent in medicines. It may also provide antioxidant properties to help preserve the product's stability.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 6T47AS764T
    Red 40 Lake is a synthetic colorant made by combining Red 40 dye with aluminum hydroxide. It's used to give tablets, capsules, and other medicines a red or pink color for identification and appearance.
  • UNII GYP6Z2JR6Q
    FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • 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.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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.
  • 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.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.
  • 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.

19 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesCarmine, Citric Acid, Cornstarch, Cranberry Extract, Croscarmellose Sodium, FD&C Red No. 40, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Pregelatinized Starch, Silicon Dioxide, Talc, Titanium Dioxide and Triacetin.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerKobayashi Healthcare International, Inc.
Labeler code52389
First marketedApr 2008
Product typeHuman Otc Drug
Portfolio26 products on file

More NDCs from Kobayashi Healthcare International, Inc. labeler code 52389

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 💬 Information for Patients 📄 Do Not Use 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

Uses Prompt temporary relief of: pain during urination burning sensation of urgency increased frequency associated with urinary tract infections.

⏱️ Dosage and Administration 85 words ▾

Directions Read all package directions and warnings before use. Use only as directed. Do not exceed recommended dosage. Adults: 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. 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 should use only as directed by a doctor.

⚠️ Warnings 1 words ▾

Warnings

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Phenazopyridine hydrochloride, 99.5 mg

🧪 Inactive Ingredients 44 words ▾

Inactive ingredients Carmine, Citric Acid, Cornstarch, Cranberry Extract, Croscarmellose Sodium, FD&C Red No. 40, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Pregelatinized Starch, Silicon Dioxide, Talc, Titanium Dioxide and Triacetin.

🎯 Purpose 3 words ▾

Purpose Urinary Analgesic

💬 Information for Patients 141 words ▾

Other information WARNING: this product contains a chemical known to the State of California to cause cancer. Precaution: Carcinogenesis: Long-term administration of phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver) . Although no association between phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. **Contents sealed: Each URICALM dark red colored, round shaped tablet bears the identifying mark "ALVA" and a "1" on the reverse side, and is sealed in a clear plastic blister with with foil backing.

Do not use if seal appears broken or if product contents do not match product description. This product may stain soft contact lenses. This product can interfere with laboratory tests including urine, glucose (sugar) and ketones.

You may report serious side effects to the phone number provided under Questions? below.

📄 Do Not Use 23 words ▾

Do not use if you have liver or kidney problems allergies to foods, preservatives or dyes had a hypersensitive reaction to phenazopyridine hydrochloride.

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking any other medications.

📄 When Using This Product 34 words ▾

When using this product stomach upset may occur; taking this product with or after meals may reduce stomach upset you may experience a reddish-orange discoloration of the urine which is a non-harmful temporary effect.

📄 Stop Use and Ask a Doctor If 39 words ▾

Stop use and ask a doctor if your symptoms do not go away after two days or become worse you experience fever, chills, back pain or bloody urine you suspect you are having an adverse reaction to this medication.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

📄 Questions or Comments 2 words ▾

Questions? 1-800-792-2582.

📄 Patient Package Insert ~3 min read ▾

Product Insert Uricalm 199 mg Strong per dose The Highest Dose of Clinically Proven Phenazopyridine Hydrochloride Available Over the Counter, Plus Cranberry URICALM provides the maximum non-prescription strength of clinically proven Phenazopyridine Hydrochloride to relieve pain, burning, increased frequency, and sensation of urgency associated with urinary tract infections. Phenazopyridine Hydrochloride is the #1 doctor recommended ingredient for fast relief of UTI pain. Plus, URICALM contains cranberry, which is used extensively by those concerned about urinary tract health.

Active ingredient (in each tablet): Phenazopyridine Hydrochloride 99.5 mg Purpose: Urinary analgesic Uses: Prompt temporary relief of pain during urination burning sensation of urgency increased frequency associated with urinary tract infections. Warnings Do not use if you have liver or kidney problems allergies to foods, preservatives or dyes had a hypersensitive reaction to phenazopyridine hydrochloride When using this product stomach upset may occur; taking this product with or after meals may reduce stomach upset you may experience a reddish-orange discoloration of the urine which is a non-harmful temporary effect.

Ask a doctor or pharmacist before use if you are taking any other medications. Stop use and ask a doctor if your symptoms do not go away after two days or become worse you experience fever, chills, back pain or bloody urine. you suspect you are having an adverse reaction to this medication If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

In case of overdose, get medical help or contact a poison control center right away. Directions: Read all package directions and warnings before use. Use only as directed.

Do not exceed recommended dosage. Adults: 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. Do not use more than 12 tablets in 2 days Drink 6 to 8 glasses of water daily. For use by normally healthy persons only.

Persons under 18 years of age should use only as directed by a doctor. Other information: WARNING: This product contains a chemical known to the State of California to cause cancer. Precaution: Carcinogenesis: Long-term administration of phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver).

Although no association between phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. **Contents sealed: Each URICALM dark red colored, round shaped tablet bears the identifying mark "ALVA" and a "1" on the reverse side, and is sealed in a clear plastic blister with foil backing. Do not use if seal appears broken or if product contents do not match product description. This product may stain soft contact lenses.

This product can interfere with laboratory tests including urine, glucose (sugar) and ketones. You may report serious side effects to the phone number provided under Questions? below. Inactive ingredients: Carmine, citric acid, corn starch, cranberry fruit extract, croscarmellose sodium, FD&C Red No.

40, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, talc, titanium dioxide and triacetin.

Questions? 1-800-792-2582 www.URICALM.com Uricalm 199 mg de concentración por dosis Contiene la dosis más alta de phenazopyridine hydrochloride clínicamente comprobado disponible en venta sin receta, además de arándano URICALM ofrece la dosis más alta de chlorhidrato de fenazopyridina clínicamente comprobado de venta sin receta para aliviar el dolor, el ardor, el aumento en la frequencia y la sensación de necesidad urgente de orinar asociados con las infecciones del tracto urinario. El chlorhidrato de fenazopiridina es el ingrediente N. o 1… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 1 words ▾

PDP

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Kobayashi Healthcare International, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 24 tablets (52389-0241-48), 28 tablets (52389-0241-28). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Kobayashi Healthcare International, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 52389-0237-28 · Kobayashi 52389-0242-10 · Kobayashi →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.