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Sunmark Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg Tablet, 12-count — NDC 70677-0078-1 (Billing 70677-0078-01)

by Strategic Sourcing Services LLC · 1 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK

This is a package of 12 tablets of Sunmark Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg Tablet from Strategic Sourcing Services LLC, marketed since Sep 2019 and currently FDA-listed; retail pharmacies pay about $0.1863 per tablet (NADAC). It is this product's only package size.

NDC 70677-0078-01
🏷️ FDA NDC (as labeled) 70677-0078-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70677-0078-1
Product NDC 70677-0078
11-digit billing NDC 70677007801
NCPDP billing unit EA — each (per item)
RxCUI 1094147
UNII 0EWG668W17
UPC 0010939940445
SPL Set ID cbc5de43-0f89-4e71-a764-749ef0ba2dfa
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-12
Route ORAL
Dosage form TABLET
Substance PHENAZOPYRIDINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 56300010100353
GPI class SM Urinary Pain Relief
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 SM URINARY PAIN RLF 99.5 MG TB
FDB brand name Urinary Pain Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 079502
  • GCN: 46004
  • GPI-14 (Medi-Span): 56300010100353
  • HICL (First Databank): 004108
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1094147
Why two NDCs? The FDA registers this code as 70677-0078-1 — a 5-4-1 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 package segment → 70677-0078-01. 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.

Clinical

Label name SM URINARY PAIN RLF 99.5 MG TB Ingredient Phenazopyridine Hcl
📗 Our plain-language guide HelloPharmacist
  • It only helps with the pain — it doesn't kill the bacteria causing the infection. Think of it as taking the edge off while your antibiotic does the real work. If you have a UTI, yo...
  • Does phenazopyridine actually treat my UTI, or does it just help with the pain?
  • That's completely expected with phenazopyridine — it's one of the most common things people notice. The drug itself has an orange-red dye, and it passes into your urine, which is w...
  • Why is my urine turning orange or red? Should I be worried?
📖 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.

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 $0.186 $2.24 / 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 2021 Mar 2022 Oct 2022 Feb 2024 $0.198 $0.151
▲ Up 23% over the last 12 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70677-0078-01 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK 2019-09-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Neighbor Maximum Strength Urinary Pain Relief 99.5 mg 46122-0628-53 AmerisourceBergen 12 tablets $0.184 — Availability likely save 1%
URO-PAIN Maximum Strength 99.5 mg 57237-0330-21 Rising 12 tablets $0.184 — Availability likely save 1%
Leader Maximum Strength Urinary Pain Relief 99.5 mg 70000-0523-01 Cardinal 12 tablets $0.184 — Availability likely save 1%
Foster and Thrive Maximum Strength Urinary Pain Relief 99.5 mg 70677-1230-01 Strategic 12 tablets $0.184 — Availability likely save 1%
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 mgthis 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 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

🏛️
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.

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.

Manufacturer & labeler

LabelerStrategic Sourcing Services LLC
Labeler code70677
First marketedSep 2019
Product typeHuman Otc Drug
Portfolio316 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.

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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children
🎯 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

📄 Ask a Doctor Before Use If 24 words ▾

Ask doctor before use if you have ■ kidney disease ■ allergies to food, preservatives or dyes ■ had a hypersensitive reaction to phenazopyridine

📄 When Using This Product 44 words ▾

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 a Doctor If 27 words ▾

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 Breast-Feeding 11 words ▾

If pregnant or breast feeding, Ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

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

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

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 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

Life-threatening18
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.

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) — 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
← 70677-0064-01 · Strategic 70677-0081-01 · Strategic →
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.