NDC 49348-0076-44 — Sunmark Urinary Pain Relief PHENAZOPYRIDINE

🆔 Identity & classification

FDA NDC (as labeled) 49348-076-44

Product NDC 49348-076

11-digit billing NDC 49348007644

NCPDP billing unit EA — each (per item)

RxCUI 1094126

UNII 0EWG668W17

UPC 0010939679444

SPL Set ID 76653afb-7829-4fa4-acd0-aaac41ce0bf2

DEA schedule Non-controlled

Marketing category UNAPPROVED DRUG OTHER

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2013-07-01

Route ORAL

Dosage form TABLET

Substance PHENAZOPYRIDINE HYDROCHLORIDE

GPI-14 56300010100303

GPI class SM Urinary Pain Relief

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 SM URINARY PAIN RLF 95 MG TAB

FDB brand name Urinary Pain Relief

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 49348-076-44 — 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 → 49348-0076-44. 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

LabelerStrategic Sourcing Services LLC

Labeler code49348

First marketedJul 2013

Product typeHuman Otc Drug

Portfolio315 products on file

🔎 All NDCs from Strategic Sourcing Services LLC

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 SM URINARY PAIN RLF 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?

📖 Read our full Phenazopyridine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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	$0.5641	$16.92 / 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 15% over the last 24 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 mg 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 mgthis 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

🏛️

2013

On the market since

Jul 2013

📍

2026

Currently FDA-listed

13 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 49348-0076-44, 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

11

Units reimbursed last 4 qtrs

236

Gross reimbursed last 4 qtrs

$133.13

Avg / prescription

$12.10

Avg / unit

$0.5641

Latest quarter Q4 2025

0Rx

Medicaid pays / ea

$0.5641

gross reimbursed

vs

NADAC / ea

$0.1321

acquisition cost

=

Spread

+$0.4320

+327% 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 ⓘ

100% MCO

Fee-for-service · 0 Rx Managed care · 11 Rx

State Medicaid map

Units reimbursed · per 100k residents

11.911.9

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

🏆 Top states by units · per 100k residents

1 Nebraska 11.9 /100k

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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sunmark Urinary Pain Relief (this brand).

Top reported reactions

Sulphaemoglobinaemia27

Pain25

Nausea22

Myocardial Infarction18

Urinary Tract Infection17

Fatigue16

Headache16

Age at onset

Adolescent2

Adult31

Elderly21

Reporter sex

Male · 25%

Female · 75%

Serious outcomes

Hospitalization117

Life-threatening18

Death14

Disabling8

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
49348-0076-44 You're viewing this	1 BLISTER PACK in 1 CARTON (49348-076-44) / 30 TABLET in 1 BLISTER PACK	2013-07-01	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	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 49348-076-44, 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: 49348-0076-44, written without dashes as 49348007644. 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 49348-0076-44, the first segment (49348) is the labeler code FDA assigned to Strategic Sourcing Services LLC; the middle segment (0076) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (44) 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 Strategic Sourcing Services LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Strategic Sourcing Services LLC 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 13 words ▾

Uses fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.

⏱️ Dosage and Administration 48 words ▾

Directions ■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed ■ Children under 12: consult a doctor ■ Do not use for more than 2 days (12 tablets) without consulting a doctor

⚠️ Warnings 6 words ▾

Warning Do not exceed recommended dosage

🧪 Active Ingredient 6 words ▾

Active Ingredient Phenazopyridine Hydrochloride 95 mg

🧪 Inactive Ingredients 31 words ▾

Inactive Ingredients lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate. May also contain: corn starch, croscarmellose sodium, polyvinylpyrrolidone, pregelatinized starch and silicon dioxide. image of carton

🎯 Purpose 3 words ▾

Purpose Urinary Analgesic

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

🔗 Related NDC lookups

🧪 All Phenazopyridine Hydrochloride NDCsSame ingredient 🏭 All Strategic labeler NDCsLabeler code 49348

Sunmark Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE 95 mg Tablet, 30-count

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Listed without an FDA application

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups