Rugby Phenazopyridine HCl Urinary Tract Analgesic PHENAZOPYRIDINE HYDROCHLORIDE 95 mg Tablet, 30-count
by Rugby Laboratories · 1 BLISTER PACK in 1 CARTON (0536-1411-07) / 30 TABLET in 1 BLISTER PACK
NDC 00536-1411-07
🏷️ FDA NDC (as labeled)
0536-1411-07
billing pads the labeler segment with a zero
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 →
🆔 Identity & classification
FDA NDC (as labeled)
0536-1411-07
Product NDC
0536-1411
11-digit billing NDC
00536141107
NCPDP billing unit
EA — each (per item)
RxCUI
1094126
UNII
0EWG668W17
SPL Set ID
7519c0ac-586a-4aa5-a7fe-0e10cbc4bfc6
DEA schedule
Non-controlled
Marketing category
UNAPPROVED DRUG OTHER
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-12-07
Route
ORAL
Dosage form
TABLET
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
GPI-14
56300010100303
GCN Seq No
016828
GCN
42123
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
PHENAZOPYRIDINE HCL 95 MG TAB
FDB brand name
Phenazopyridine Hcl
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0536-1411-07 — a 4-4-2 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 labeler segment → 00536-1411-07. 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
LabelerRugby Laboratories
Labeler code00536
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio149 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 PHENAZOPYRIDINE HCL 95 MG TAB 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about PHENAZOPYRIDINE HYDROCHLORIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
red
ShapeRound
ImprintP95
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 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 J2B2A4N98G
Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
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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 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 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 AG9B65PV6B
A starch derivative made from corn that helps tablets and capsules break apart quickly when swallowed. It acts as a disintegrant, allowing the medicine to dissolve and be absorbed in your stomach and intestines.
-
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 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.
12 inactive ingredients listed in the exact product block matched to this NDC.
The official label also stateslactose, corn starch, croscarmellose sodium, microcrystalline cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate, pregelatinized starch, silicon dioxide, talc, 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.
💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.132 | $3.96 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $3.25 | $97.61 / 30 tablets |
| 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
▲ Up 5% 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Quality Choice Urinary Pain Relief 95 mg 63868-0117-30 | Chain | 30 tablets | $0.118 | — | FDA listed | save 11% |
| HealthMart Urinary Pain Relief 95 mg 62011-0325-01 | Strategic | 30 tablets | $0.120 | — | FDA listed | save 9% |
| Rugby Phenazopyridine HCl Urinary Tract Analgesic 95 mgthis 00536-1411-07 | Rugby | 30 tablets | $0.132 | — | Availability likely | — |
| Good Neighbor Pharmacy Urinary Pain Relief 95 mg 46122-0337-65 | AmerisourceBergen | 30 tablets | $0.132 | — | Availability likely | — |
| Sunmark Urinary Pain Relief 95 mg 49348-0076-44 | Strategic | 30 tablets | $0.132 | — | Availability likely | — |
| Uro-Pain 95 mg 57237-0331-03 | Rising | 30 tablets | $0.132 | — | Availability likely | — |
| Leader Urinary Pain Relief 95 mg 70000-0243-01 | Cardinal | 30 tablets | $0.132 | — | Availability likely | — |
| Foster and Thrive Neighbor Pharmacy Urinary Pain Relief 95 mg 70677-1229-01 | Strategic | 30 tablets | $0.132 | — | Availability likely | — |
| Walgreens Urinary Pain Relief 95 mg 00363-7775-30 | Walgreens | 30 tablets | — | — | FDA listed | — |
| CVS Health Urinary Pain Relief 95 mg 10956-0001-30 | Reese | 30 tablets | — | — | FDA listed | — |
| Preferred Urinary Pain Relief 95 mg 10956-0551-30 | Reese | 30 tablets | — | — | FDA listed | — |
| Rite Aid Urinary Pain Relief 95 mg 11822-8855-06 | Rite | 30 tablets | — | — | FDA listed | — |
| Kroger Urinary Pain Relief 95 mg 30142-0564-30 | THE | 30 tablets | — | — | FDA listed | — |
| TopCare Urinary Pain Relief 95 mg 36800-0040-30 | TOPCO | 30 tablets | — | — | FDA listed | — |
| Skopko Urinary Pain Relief 95 mg 37012-0098-01 | Skopko | 32 tablets | — | — | FDA listed | — |
| Azo 95 mg 49973-0301-31 | i-Health, | 30 tablets | — | — | FDA listed | — |
| Phenazopyridine Hydrochloride 95 mg 68071-2273-03 | NuCare | 30 tablets | — | — | FDA listed | — |
| Good Neighbor Pharmacy Urinary Pain Relief 95 mg 71205-0584-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Quality Choice Urinary Pain Relief 95 mg 83324-0201-30 | Chain | 30 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00536-1411-07, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
326
Units reimbursed last 4 qtrs
5.6K
Gross reimbursed last 4 qtrs
$18.2K
Avg / prescription
$55.75
Avg / unit
$3.2538
Latest quarter Q4 2025
71Rx
Medicaid pays / ea
$3.2538
gross reimbursed
vs
NADAC / ea
$0.1321
acquisition cost
=
Spread
+$3.1217
+2363% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 0 Rx Managed care · 326 Rx
State Medicaid map
Units reimbursed · per 100k residents
1.356.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00536-1411-07 You're viewing this | 1 BLISTER PACK in 1 CARTON (0536-1411-07) / 30 TABLET in 1 BLISTER PACK | 2023-12-07 | Active |
🧭 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) | ✓ Available |
“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 0536-1411-07, 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: 00536-1411-07, written without dashes as 00536141107. 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 00536-1411-07, the first segment (00536) is the labeler code FDA assigned to Rugby Laboratories; the middle segment (1411) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 Rugby Laboratories. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rugby Laboratories 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 ▾
Uses fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
⏱️ Dosage and Administration ▾
Directions ■ Adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed ■ Children under 12 years: consult a doctor ■ Do not use for more than 2 days (12 tablets) without consulting a doctor
⚠️ Warnings ▾
Warning Do not exceed recommended dosage Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician
🧪 Active Ingredient ▾
Active Ingredient Phenazopyridine Hydrochloride 95 mg
🧪 Inactive Ingredients ▾
Inactive Ingredients lactose, corn starch, croscarmellose sodium, microcrystalline cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate, pregelatinized starch, silicon dioxide, talc, and triacetin. image of carton
🎯 Purpose ▾
Purpose Urinary Analgesic
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.