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Azo Urinary Tract Defense Antibacterial Protection Methenamine, Sodium salicylate 162 mg; 162.5 mg Tablet, 48-count

by i-Health, Inc. · 2 BLISTER PACK in 1 BOX (49973-011-48) / 24 TABLET in 1 BLISTER PACK
NDC 49973-0011-48
🏷️ FDA NDC (as labeled) 49973-011-48 billing pads the product segment with a zero
This package
Contains48-count Pack sizes3 compare ↓
Also comes in: 18 tablets 49973-0011-18 24 tablets 49973-0011-24
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 49973-011-48
Product NDC 49973-011
11-digit billing NDC 49973001148
RxCUI 1489932, 1721434
UNII J50OIX95QV, WIQ1H85SYP
SPL Set ID ba13a608-e4c5-4465-8be8-be0fd1fd46ae
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-11-06
Route ORAL
Dosage form TABLET
Substance METHENAMINE; SODIUM SALICYLATE
Why two NDCs? The FDA registers this code as 49973-011-48 — 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 → 49973-0011-48. 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 antibacterials class.

Drug family (ATC) Other antibacterials
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 marketedNov 2015
Product typeHuman Otc Drug
Portfolio4 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 is this product?

This is an oral tablet containing methenamine and sodium salicylate, marketed as an over-the-counter urinary tract product. Methenamine is typically used in urinary antiseptics and functions by converting to formaldehyde in acidic urine to help reduce bacteria. Sodium salicylate is a salicylate compound commonly used in over-the-counter products for pain and inflammation relief. This product is marketed without an approved FDA application.

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 red
ShapeRound
ImprintAZOUD
Size1 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.

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 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: 18 tablets 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 Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 46122-0622-62 AmerisourceBergen 24 tablets $0.177 — Availability likely —
URO-PAIN Dual Action Antibacterial Protection 162 mg/1; 162.5 mg 57237-0332-42 Rising 24 tablets $0.177 — Availability likely —
Walgreens Pain Relief plus UTI Bacteria Control 162 mg/1; 162.5 mg 00363-1277-48 Walgreen 48 tablets — — FDA listed —
Walgreens Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 00363-4404-24 Walgreen 24 tablets — — FDA listed —
Preferred Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 10956-0763-24 Reese 24 tablets — — FDA listed —
Rite Aid Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 11822-4892-04 Rite 24 tablets — — FDA listed —
TopCare Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 36800-0314-24 Topco 24 tablets — — FDA listed —
Meijer Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 41250-0557-24 Meijer 24 tablets — — FDA listed —
Azo Urinary Tract Defense Antibacterial Protection 162 mg/1; 162.5 mgthis 49973-0011-48 i-Health, 48 tablets — — FDA listed —
Cvs Dual Action Pain Relief 162 mg/1; 162.5 mg 51316-0777-48 CVS 48 tablets — — FDA listed —
Quality Choice Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 63868-0187-24 Chain 24 tablets — — FDA listed —
Premier Value Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 68016-0003-24 Chain 24 tablets — — FDA listed —
Cystex Plus 162 mg/1; 162.5 mg 69693-0512-20 Clarion 20 tablets — — FDA listed —
Cystex 162 mg/1; 162.5 mg 69693-0513-24 Clarion 24 tablets — — FDA listed —
Cystex 162 mg/1; 162.5 mg 69693-0518-24 Clarion 24 tablets — — FDA listed —
CVS Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 69842-0314-24 CVS 24 tablets — — FDA listed —
Uti Infection Control 162 mg/1; 162.5 mg 73436-1221-02 CADENCE 12 tablets — — FDA listed —
Quality Choice Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 83324-0198-24 Chain 24 tablets — — FDA listed —
Gencare-Urinary Tract Defense 162 mg/1; 162.5 mg 72090-0065-01 PIONEER 48 tablets — — FDA listed —
Nuvicare-Urinary Tract Defense 162 mg/1; 162.5 mg 84324-0041-01 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

🏛️
2015
On the market since
Nov 2015
📍
2026
Currently FDA-listed
11 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 Methenamine, Sodium salicylate — the ingredient across all brands.

Top reported reactions

Nausea13
Urinary Tract Infection12
Fatigue11
Headache11
Malaise11
Pain9
Cystitis8

Age at onset

Adult3
Elderly3

Reporter sex

105 reports
Male · 5%
Female · 95%

Serious outcomes

Hospitalization28
Death9
Life-threatening3
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 16 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
49973-0011-18 1 BLISTER PACK in 1 BOX (49973-011-18) / 18 TABLET in 1 BLISTER PACK 2018-04-23 Active
49973-0011-24 1 BLISTER PACK in 1 BOX (49973-011-24) / 24 TABLET in 1 BLISTER PACK 2016-03-01 Active
49973-0011-48 You're viewing this 2 BLISTER PACK in 1 BOX (49973-011-48) / 24 TABLET in 1 BLISTER PACK 2025-12-15 Active

Pack size FAQ

What quantity is in NDC 49973-0011-48?
NDC 49973-0011-48 is a 48-count package — 2 blister pack in 1 box / 24 tablet in 1 blister pack.
What is the difference between NDC 49973-0011-48 and NDC 49973-0011-18?
Both are Azo Urinary Tract Defense Antibacterial Protection Methenamine, Sodium salicylate 162 mg; 162.5 mg Tablet — the drug itself is identical. NDC 49973-0011-48 is the 48-count package, while NDC 49973-0011-18 is the 18 tablets package.
What NDC number is used to bill for this package of Azo Urinary Tract Defense Antibacterial Protection Methenamine, Sodium salicylate 162 mg; 162.5 mg Tablet?
Bill NDC 49973-0011-48 — the 11-digit billing format is 49973001148. 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 — 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) — 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 49973-011-48, 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: 49973-0011-48, written without dashes as 49973001148. 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 49973-0011-48, the first segment (49973) is the labeler code FDA assigned to i-Health, Inc.; the middle segment (0011) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (48) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 18 tablets (49973-0011-18), 24 tablets (49973-0011-24). 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?
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 🤰 Pregnancy 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 11 words ▾

Uses Temporarily relieves: pain & burning frequency and urgency of urination

⏱️ Dosage and Administration 32 words ▾

Directions: Adults and children 12 years and over: take 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids. Children under 12 years: ask a doctor.

⚠️ Warnings ~2 min read ▾

Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. If changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding.

The chance is higher if you: take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others) have 3 or more alcoholic drinks every day while using this product have stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug are age 60 or older take more or for a longer time than directed Do not use: if you are on a sodium restricted diet if you are allergic to salicylates (including aspirin) unless directed by a doctor if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems unless directed by a doctor Ask a doctor before use if you have frequent, burning urination for the first time the stomach bleeding warning applying to you history of stomach problems, such as heartburn high blood pressure heart disease liver cirrhosis bleeding problems diuretic use ulcers kidney disease reached age 60 or older Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug When using this product do not take more than the recommended dosage Stop and ask a doctor if product has been used for 3 days you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have blood or black stools, have stomach pain that does not get better ringing in the ears or a loss of hearing occurs If pregnant or breast feeding, ask a health professional before use.

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

🤰 Pregnancy 11 words ▾

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

🧪 Active Ingredient 17 words ▾

Drug Facts Active Ingredients (in each tablet): Methenamine 162 mg Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug)

🧪 Inactive Ingredients 37 words ▾

Inactive Ingredients: Benzoic Acid, Cellulose, Croscarmellose Sodium, Edible black ink, FD&C Red #40 Lake, FD&C Yellow #6 Lake, Hydroxypropyl Cellulose, Hydroxypropyl Methylcellulose, Magnesium Stearate, Methacrylic Acid - Ethyl Acrylate Copolymer, Silica, Stearic Acid, Titanium Dioxide, Triethyl Citrate

🎯 Purpose 5 words ▾

Purpose Antibacterial Analgesic (pain reliever)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49967-0996-01 · L'Oreal 49973-0247-12 · i-Health, →
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.