NDC 49973-0301-31 — AZO Urinary Pain Relief 95 mg Tablet, 30-count

🆔 Identity & classification

FDA NDC (as labeled) 49973-301-31

Product NDC 49973-301

11-digit billing NDC 49973030131

NCPDP billing unit EA — each (per item)

RxCUI 1094126, 1094192

UNII 0EWG668W17

SPL Set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

DEA schedule Non-controlled

Marketing category UNAPPROVED DRUG OTHER

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2012-05-24

Route ORAL

Dosage form TABLET

Substance PHENAZOPYRIDINE HYDROCHLORIDE

Why two NDCs? The FDA registers this code as 49973-301-31 — 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 → 49973-0301-31. 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

Labeleri-Health, Inc.

Labeler code49973

First marketedMay 2012

Product typeHuman Otc Drug

Portfolio4 products on file

🔎 All NDCs from i-Health, Inc.

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

📗 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.

💊 What it looks like

Color brown

ShapeRound

ImprintW

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 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 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 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 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 microcrystalline cellulose, pregelatinized corn starch, hypromellose, povidine, croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable magnesium stearate. 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 system	Per each	Per 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.

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	—
HealthMart Urinary Pain Relief 95 mg 62011-0325-01	Strategic	30 tablets	$0.120	—	FDA listed	—
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 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 mgthis 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

🏛️

2012

On the market since

May 2012

📍

2026

Currently FDA-listed

14 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.

🔬 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 AZO (this brand).

Top reported reactions

Fatigue46

Urinary Tract Infection44

Nausea41

Pain35

Diarrhoea33

Headache32

Dizziness29

Age at onset

Child2

Adolescent2

Adult34

Elderly35

Reporter sex

Male · 16%

Female · 84%

Unknown · 0%

Serious outcomes

Hospitalization104

Life-threatening9

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
49973-0301-31 You're viewing this	15 BLISTER PACK in 1 BOX (49973-301-31) / 2 TABLET in 1 BLISTER PACK	2012-05-24	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)	✓ 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 FDA registers it as 49973-301-31, 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: 49973-0301-31, written without dashes as 49973030131. 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 49973-0301-31, the first segment (49973) is the labeler code FDA assigned to i-Health, Inc.; the middle segment (0301) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (31) 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 i-Health, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

i-Health, 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 or 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 114 words ▾

Warnings Please read insert for important precautions. Ask a doctor before use if you have kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to Phenazopyridine Hydrochloride. Caution: Do not use this product 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 your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication.

🧪 Active Ingredient 11 words ▾

Drug Facts Active ingredient (in each tablet) Phenazopyridine Hydrochloride 95 mg

🧪 Inactive Ingredients 24 words ▾

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

🎯 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 Urinary Pain Relief NDCsSame ingredient 🏭 All i-Health, labeler NDCsLabeler code 49973