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URO-PAIN Dual Action Antibacterial Protection Methenamine, Sodium salicylate 162 mg; 162.5 mg Tablet, 24-count — NDC 57237-0332-42 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

URO-PAIN Dual Action Antibacterial Protection Methenamine, Sodium salicylate 162 mg; 162.5 mg Tablet, 24-count — NDC 57237-332-42 (Billing 57237-0332-42)

by Rising Pharma Holdings, Inc. · 1 BLISTER PACK in 1 BOX / 24 TABLET in 1 BLISTER PACK

This is a package of 24 tablets of URO-PAIN Dual Action Antibacterial Protection Methenamine, Sodium salicylate 162 mg; 162.5 mg Tablet from Rising Pharma Holdings, Inc., marketed since Dec 2023 and currently FDA-listed; retail pharmacies pay about $0.1759 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 57237-0332-42
🏷️ FDA NDC (as labeled) 57237-332-42 billing pads the product segment with a zero
This package
Contains24-count Cost per ea$0.1759 NADAC Per package$4.22 / 24 tablets Pack sizes2 compare ↓
Main listing for product 57237-332 · Also comes in: 18 tablets 57237-332-81
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 57237-332-42 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
57237 labeler · 332 product · 42 package
Package marketed since
Dec 6, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
24 EA per package
Barcode (UPC-A, from the NDC)
3 5723733242 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57237-332-42
Product NDC 57237-332
11-digit billing NDC 57237033242
NCPDP billing unit EA — each (per item)
RxCUI 1489932
UNII J50OIX95QV, WIQ1H85SYP
SPL Set ID f8ff15be-e537-4acc-a6e6-5934ff8b48ae
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-06
Route ORAL
Dosage form TABLET
Substance METHENAMINE; SODIUM SALICYLATE

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

GCN Seq No 065961
GCN 28102
HICL code 036801
Ingredient (HICL) Methenamine/Sodium Salicylate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2G
Therapeutic class — specific (HIC3) Antibiotic, Antibacterial, Misc.
AHFS code 08:36.00.00
AHFS class Urinary Anti-Infectives
FDB label name URO-PAIN DUAL 162-162.5 MG TAB
FDB brand name Uro-Pain Dual Action
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 065961
  • GCN: 28102
  • HICL (First Databank): 036801
  • AHFS class code: 08:36.00.00
  • RxCUI (RxNorm): 1489932
Why two NDCs? The FDA registers this code as 57237-332-42 — 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 → 57237-0332-42. 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.

Clinical

Label name URO-PAIN DUAL 162-162.5 MG TAB Ingredient Methenamine/Sodium Salicylate
🧪 What is this product?

URO-Pain is an unapproved oral tablet containing methenamine and sodium salicylate. Methenamine is commonly used in urinary products for its antibacterial properties in the urinary tract. Sodium salicylate is a pain reliever and anti-inflammatory agent typically used to reduce discomfort. 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.

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 $0.176 $4.22 / 24 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 2025 Mar 2026 Jun 2026 Sep 2026 $0.180 $0.166
▲ Up 6% over the last 10 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 Per unit Per pack Marketing startMarketing endStatus
57237-0332-42 You're viewing this Main listing 1 BLISTER PACK in 1 BOX / 24 TABLET in 1 BLISTER PACK $0.1759 / ea $4.22 2023-12-06 — Active
57237-0332-81 57237-332-81 1 BLISTER PACK in 1 BOX / 18 TABLET in 1 BLISTER PACK — — 2023-12-06 — Active

Pack size FAQ

What quantity is in this package?
This is a 24-count package — 1 blister pack in 1 box / 24 tablet in 1 blister pack.
How does this package differ from NDC 57237-0332-81?
Both are URO-PAIN Dual Action Antibacterial Protection Methenamine, Sodium salicylate 162 mg; 162.5 mg Tablet — the drug itself is identical. This page's package is the 24-count one, while NDC 57237-0332-81 is the 18 tablets package.
What NDC number is used to bill for this package of URO-PAIN Dual Action Antibacterial Protection Methenamine, Sodium salicylate 162 mg; 162.5 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

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 $0.176 — Availability likely —
URO-PAIN Dual Action Antibacterial Protection 162 mg/1; 162.5 mgthis 57237-0332-42 Rising 24 tablets $0.176 — 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 mg 49973-0011-18 i-Health, 18 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 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.

What it looks like

Color red
ShapeRound
ImprintURO
Size10 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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • 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 NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII SMD1X3XO9M
    Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

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

The official label also statesInactive 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

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.

Manufacturer & labeler

LabelerRising Pharma Holdings, Inc.
Labeler code57237
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio525 products on file

More NDCs from Rising Pharma Holdings, Inc. labeler code 57237

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 🤰 Pregnancy 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

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

⏱️ Dosage and Administration 33 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 bloody or black stools, have stomach pain that does not get better ringing in the ears or a loss of hearing occurs If pregnant or breastfeeding, ask a health professional before use.

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

🤰 Pregnancy 10 words ▾

If pregnant or breastfeeding, ask a health professional before use.

🧪 Active Ingredient 18 words ▾

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

🧪 Inactive Ingredients 39 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)

📄 Do Not Use 54 words ▾

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 48 words ▾

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 31 words ▾

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 12 words ▾

When using this product: do not take more than the recommended dosage

📄 Stop Use and Ask a Doctor If 50 words ▾

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 bloody or black stools, have stomach pain that does not get better ringing in the ears or a loss of hearing occurs

📄 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.

📄 Other Information 38 words ▾

Other Information: each tablet contains 25 mg of sodium store at 59°-86°F (15°-30°C) in a dry place protect from light Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged

📄 Questions or Comments 24 words ▾

Questions or comments? Call 1-844-474-7464 Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India Mfg License Code: RA/Drug/RAJ.-1750 Issued: 09/2023

📄 Package Label / Principal Display Panel 43 words ▾

Case Label NDC 57237-332-42 URO-PAIN Dual Action Antibacterial Urinary Pain Relief Methenamine and Sodium Salicylate (NSAID) Tablets 162 mg; 162.5 mg * Helps inhibit the progression of infection until you see your healthcare professional. URO is not intended to replace medical care. uro-pain-label01

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 Methenamine, Sodium salicylate — the ingredient across all brands.

Top reported reactions

Nausea13
Urinary Tract Infection12
Fatigue11
Headache11
Malaise11
Pain9
Cystitis8

Reporter sex

105 reports

Serious outcomes

Death9
Life-threatening3
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 16 1
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 ✓ Available
Inactive ingredients (structured) ✓ 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 Rising Pharma Holdings, 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 1 other package presentation of this same product, including 18 tablets (57237-0332-81). 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?
Rising Pharma Holdings, 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.
← 57237-0331-03 · Rising 57237-0333-01 · Rising →
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.