Care One Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg Tablet, 12-count — NDC 72476-0210-12 package photo

Care One Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg Tablet, 12-count

by Retail Business Services , LLC. · 1 BLISTER PACK in 1 CARTON (72476-210-12) / 12 TABLET in 1 BLISTER PACK
NDC 72476-0210-12
🏷️ FDA NDC (as labeled) 72476-210-12 billing pads the product segment with a zero
This package
Contains12-count Pack sizes2 compare ↓
Also comes in: 24 tablets 72476-0210-24
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) 72476-210-12
Product NDC 72476-210
11-digit billing NDC 72476021012
RxCUI 1094147
UNII 0EWG668W17
SPL Set ID f526a9f5-2e57-4bc2-9d3c-85e51266ee0e
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-20
Route ORAL
Dosage form TABLET
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 72476-210-12 — 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 → 72476-0210-12. 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

LabelerRetail Business Services , LLC.
Labeler code72476
First marketedSep 2019
Product typeHuman Otc Drug
Portfolio23 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

📖 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 →
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • UNII 9B9691B2N9
    Magnesium silicate is a mineral compound used in tablets and capsules as a glidant and anti-caking agent. It helps powder ingredients flow smoothly during manufacturing and prevents clumping in the final product.

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

The official label also statesLactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.

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 DailyMedingredient 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 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
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 mg 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
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 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 mgthis 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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 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 Care One Maximum Strength Urinary Pain Relief (this brand).

Top reported reactions

Sulphaemoglobinaemia27
Pain25
Nausea22
Myocardial Infarction18
Urinary Tract Infection17
Fatigue16
Headache16

Reporter sex

201 reports

Serious outcomes

Hospitalization117
Death14
Disabling8
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 40 0
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 NDCDescription Marketing startStatus
72476-0210-12 You're viewing this 1 BLISTER PACK in 1 CARTON (72476-210-12) / 12 TABLET in 1 BLISTER PACK 2019-09-20 Active
72476-0210-24 1 BLISTER PACK in 1 CARTON (72476-210-24) / 24 TABLET in 1 BLISTER PACK 2019-09-20 Active

Pack size FAQ

What quantity is in NDC 72476-0210-12?
NDC 72476-0210-12 is a 12-count package — 1 blister pack in 1 carton / 12 tablet in 1 blister pack.
What is the difference between NDC 72476-0210-12 and NDC 72476-0210-24?
Both are Care One Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg Tablet — the drug itself is identical. NDC 72476-0210-12 is the 12-count package, while NDC 72476-0210-24 is the 24 tablets package.
What NDC number is used to bill for this package of Care One Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg Tablet?
Bill NDC 72476-0210-12 — the 11-digit billing format is 72476021012. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 72476-210-12, 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: 72476-0210-12, written without dashes as 72476021012. 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 72476-0210-12, the first segment (72476) is the labeler code FDA assigned to Retail Business Services , LLC.; the middle segment (0210) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 Retail Business Services , LLC.. 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 (72476-0210-24). 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?
Retail Business 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 15 words

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

⏱️ Dosage and Administration 53 words

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 image of carton

⚠️ Warnings 6 words

Warnings Do not exceed recommended dosage

🧪 Active Ingredient 10 words

Active ingredient (in each tablet) Phenazopyridine Hydrochloride 99.5 mg .

🧪 Inactive Ingredients 15 words

Inactive ingredients Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.

🎯 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 ↗
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.