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URO-PAIN Maximum Strength Phenazopyridine Hydrochloride 99.5 mg Tablet, 12-count — NDC 57237-0330-21 package photo

URO-PAIN Maximum Strength Phenazopyridine Hydrochloride 99.5 mg Tablet, 12-count

by Rising Pharma Holdings, Inc. · 1 BLISTER PACK in 1 CARTON (57237-330-21) / 12 TABLET in 1 BLISTER PACK
NDC 57237-0330-21
🏷️ FDA NDC (as labeled) 57237-330-21 billing pads the product segment with a zero
This package
Contains12-count Cost per ea$0.1847 NADAC Per package$2.22 / 12 tablets Pack sizes2 compare ↓
Also comes in: 24 tablets 57237-0330-42
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 57237-330-21
Product NDC 57237-330
11-digit billing NDC 57237033021
NCPDP billing unit EA — each (per item)
RxCUI 1094147
UNII 0EWG668W17
SPL Set ID a8e51a62-366c-4533-a5a4-7f996f6f6bd0
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-06
Route ORAL
Dosage form TABLET
Substance PHENAZOPYRIDINE HYDROCHLORIDE
GPI-14 56300010100353
GCN Seq No 079502
GCN 46004
HICL code 004108
Ingredient (HICL) Phenazopyridine Hcl
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R5
Therapeutic class — intermediate (HIC2) Urinary Tract Anesthetic/Analgesic Agents
HIC3 code R5A
Therapeutic class — specific (HIC3) Urinary Tract Anesthetic/Analgesic Agnt (Azo-Dye)
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name URO-PAIN 99.5 MG TABLET
FDB brand name Uro-Pain
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 57237-330-21 — 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 → 57237-0330-21. 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.

🏭 Manufacturer & labeler

LabelerRising Pharma Holdings, Inc.
Labeler code57237
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio525 products on file
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.

🩺 Clinical

Label name URO-PAIN 99.5 MG TABLET Ingredient Phenazopyridine Hcl
📖 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
  • No — and this is really important to understand. Phenazopyridine only relieves the pain, burning, and urgency. It does not kill the bacteria causing your infection. You still need...
  • Will phenazopyridine actually cure my UTI?
  • Yes, completely expected. Phenazopyridine turns urine — and sometimes tears, sweat, or other body fluids — a vivid orange or red color. It's harmless, but it can stain contact lens...
  • My urine turned bright orange — is that normal?
📖 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.

💊 What it looks like

Color red
ShapeCapsule
Imprintp99
Size9 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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • 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 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 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 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 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.

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

The official label also statesInactive ingredients   carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.

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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.185 $2.22 / 12 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.197 $0.175
▲ Up 6% over the last 9 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Neighbor Maximum Strength Urinary Pain Relief 99.5 mg 46122-0628-53 AmerisourceBergen 12 tablets $0.185 — Availability likely —
URO-PAIN Maximum Strength 99.5 mgthis 57237-0330-21 Rising 12 tablets $0.185 — Availability likely —
Leader Maximum Strength Urinary Pain Relief 99.5 mg 70000-0523-01 Cardinal 12 tablets $0.185 — Availability likely —
Foster and Thrive Maximum Strength Urinary Pain Relief 99.5 mg 70677-1230-01 Strategic 12 tablets $0.185 — Availability likely —
HealthMart Maximum Strength Urinary Pain Relief 99.5 mg 62011-0412-01 Strategic 12 tablets $0.186 — FDA listed +1%
Sunmark Maximum Strength Urinary Pain Relief 99.5 mg 70677-0078-01 Strategic 12 tablets $0.186 — FDA listed +1%
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 mg 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 —
Gencare-Urinary Pain Relief Maximum Strength 99.5 mg 72090-0072-01 Pioneer 72 tablets — — FDA listed —
Nuvicare-Urinary Pain Relief Maximum Strength 99.5 mg 84324-0042-01 NUVICARE 24 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
57237-0330-21 You're viewing this 1 BLISTER PACK in 1 CARTON (57237-330-21) / 12 TABLET in 1 BLISTER PACK $0.1847 / ea $2.22 2023-12-06 Active
57237-0330-42 1 BLISTER PACK in 1 CARTON (57237-330-42) / 24 TABLET in 1 BLISTER PACK $0.1847 / ea $4.43 2023-12-06 Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1847 NADAC).

Pack size FAQ

What quantity is in NDC 57237-0330-21?
NDC 57237-0330-21 is a 12-count package — 1 blister pack in 1 carton / 12 tablet in 1 blister pack.
What is the difference between NDC 57237-0330-21 and NDC 57237-0330-42?
Both are URO-PAIN Maximum Strength Phenazopyridine Hydrochloride 99.5 mg Tablet — the drug itself is identical. NDC 57237-0330-21 is the 12-count package, while NDC 57237-0330-42 is the 24 tablets package.
What NDC number is used to bill for this package of URO-PAIN Maximum Strength Phenazopyridine Hydrochloride 99.5 mg Tablet?
Bill NDC 57237-0330-21 — the 11-digit billing format is 57237033021. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

🧭 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) ✓ Available
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.
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 FDA registers it as 57237-330-21, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 57237-0330-21, written without dashes as 57237033021. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 57237-0330-21, the first segment (57237) is the labeler code FDA assigned to Rising Pharma Holdings, Inc.; the middle segment (0330) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (21) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Rising Pharma Holdings, 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 1 other package presentation of this same product, including 24 tablets (57237-0330-42). 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?
Rising Pharma Holdings, 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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

⏱️ Dosage and Administration 56 words ▾

Directions Adults and children 12 years and older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor. Children under 12: Do not use without consulting a doctor.

⚠️ Warnings 156 words ▾

Warnings Ask a doctor before use if you have kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to Phenazopyridine Hydrochloride Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician. When using this product stomach upset may occur, taking this product with or after meals may reduce stomach upset your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.

Stop use and ask doctor if your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication. If pregnant or breastfeeding, ask a healthcare professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use.

Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Phenazopyridine Hydrochloride 99.5 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.

🎯 Purpose 4 words ▾

Purpose Urinary tract analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 57237-0327-03 · Rising 57237-0331-03 · Rising →
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.