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Dimethyl Sulfoxide .54 g/mL Irrigant — NDC 84897-052-01 (Billing 84897-0052-01)

by Renova Pharmaceuticals LLC · 1 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS

This is a package of Dimethyl Sulfoxide .54 g/mL Irrigant from Renova Pharmaceuticals LLC, marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 84897-0052-01
🏷️ FDA NDC (as labeled) 84897-052-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 6, 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) 84897-052-01
Product NDC 84897-052
11-digit billing NDC 84897005201
RxCUI 562359
UNII YOW8V9698H
UPC 0384897052015
Application # ANDA220173
SPL Set ID 8f699de6-9d09-48da-9d95-4001d7008587
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-01
Route INTRAVESICAL
Dosage form IRRIGANT
Substance DIMETHYL SULFOXIDE
TE code (Orange Book) AT · RLD · RS
Quick answers
  • RxCUI (RxNorm): 562359
Why two NDCs? The FDA registers this code as 84897-052-01 — 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 → 84897-0052-01. 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, Other topical products for joint and muscular pain
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

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 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.
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
84897-0052-01 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS 2025-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rimso-50 .54 g/mL 67457-0177-50 Mylan 1 vial — AT FDA listed —
Dimethyl Sulfoxide .54 g/mLthis 84897-0052-01 Renova 1 vial — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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

  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

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

LabelerRenova Pharmaceuticals LLC
Application holderRENOVA PHARMACEUTICALS LLC
FDA applicationANDA220173 (ANDA)
Labeler code84897
First marketedDec 2025
Product typeHuman Prescription 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 51 words ▾

INDICATIONS AND USAGE Dimethyl sulfoxide is indicated for the symptomatic relief of patients with interstitial cystitis. Dimethyl sulfoxide has not been approved as being safe and effective for any other indication. There is no clinical evidence of effectiveness of dimethyl sulfoxide in the treatment of bacterial infections of the urinary tract.

⏱️ Dosage and Administration 141 words ▾

DOSAGE AND ADMINISTRATION Instillation of 50 mL of dimethyl sulfoxide directly into the bladder may be accomplished by catheter or asepto syringe and allow to remain for 15 minutes. Application of an analgesic lubricant gel such as lidocaine jelly to the urethra is suggested prior to insertion of the catheter to avoid spasm. The medication is expelled by spontaneous voiding.

It is recommended that the treatment be repeated every two weeks until maximum symptomatic relief is obtained. Thereafter, time intervals between therapy may be increased appropriately. Administration of oral analgesic medication or suppositories containing belladonna and opium prior to the instillation of dimethyl sulfoxide can reduce bladder spasm.

In patients with severe interstitial cystitis with very sensitive bladders, the initial treatment, and possibly the second and third (depending on patient response) should be done under anesthesia. (Saddle block has been suggested).

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 55 words ▾

WARNINGS Dimethyl sulfoxide can initiate the liberation of histamine and there has been occasional hypersensitivity reaction with topical administration of dimethyl sulfoxide. This hypersensitivity has been reported in one patients receiving intravesical dimethyl sulfoxide. The physician should be cognizant of this possibility in prescribing dimethyl sulfoxide. If anaphylactoid symptoms develop, appropriate therapy should be instituted.

🤒 Adverse Reactions 73 words ▾

ADVERSE REACTIONS A garlic-like taste may be noted by the patient within a few minutes after instillation of dimethyl sulfoxide. This taste may last several hours and because of the presence of metabolites, an odor on the breath and skin may remain for 72 hours. Transient chemical cystitis has been noted following instillation of dimethyl sulfoxide.

The patient may experience moderately severe discomfort on administration. Usually this becomes less prominent with repeated administration.

🆘 Overdosage 63 words ▾

OVERDOSAGE The oral LD 50 of dimethyl sulfoxide in the dog is greater than 10 gm/kg. It is improbable that this dosage level could be obtained with intravesical instillation of dimethyl sulfoxide in the patient. In case of accidental oral ingestion, specific measures should be taken to induce emesis. Additional measures which may be considered are gastric lavage, activated charcoal and force diuresis.

🧬 Clinical Pharmacology 107 words ▾

CLINICAL PHARMACOLOGY Dimethyl sulfoxide is metabolised in man by oxidation to dimethyl sulfone or by reduction to dimethyl sulfide. Dimethyl sulfoxide and dimethyl sulfone are excreted in the urine and feces. Dimethyl sulfide is eliminated through the breath and skin and is responsible for the characteristics odor from patients on dimethyl sulfoxide medication.

Dimethyl sulfone can persist in serum for longer than two weeks after a single intravesical instillation. No residual accumulation of dimethyl sulfoxide has occurred in man or lower animals who have received treatment for protracted periods of time. Following topical application, dimethyl sulfoxide is absorbed and generally distributed in the tissues and body fluids.

📦 How Supplied / Storage and Handling 62 words ▾

HOW SUPPLIED Vials contain 50 mL of sterile and non-pyrogenic dimethyl sulfoxide (50% w/w dimethyl sulfoxide aqueous solution). Dimethyl sulfoxide is clear and colorless. NDC 84897-052-01 carton containing a 50 mL vial Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from strong light. Distributed by: Renova Pharmaceuticals LLC 161 Dwight Place, Fairfield, NJ 07004 Rev. 06/2026

📦 Storage and Handling 30 words ▾

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from strong light. Distributed by: Renova Pharmaceuticals LLC 161 Dwight Place, Fairfield, NJ 07004 Rev. 06/2026

📋 Description 97 words ▾

DESCRIPTION Dimethyl Sulfoxide (DMSO) Irrigation, USP 50% w/w Aqueous Solution for intravesical instillation. Each mL contains 0.54 gm dimethyl sulfoxide STERILE AND NON-PYROGENIC. Intravesical instillation for the treatment of interstitial cystitis.

NOT FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION. The active component of irrigation is dimethyl sulfoxide which has the empirical formula C 2 H 6 OS, and is structurally represented as: Dimethyl sulfoxide is a clear, colorless and essentially odorless liquid which is miscible with water and most organic solvents. Other physical characteristics include: molecular weight 78.13, melting point 18.3°C, and a specific gravity of 1.096. image description

💬 Information for Patients ~2 min read ▾

INFORMATION FOR PATIENTS (Physician Copy) Dimethyl Sulfoxide is a sterile solution of 50% dimethyl sulfoxide (DMSO) and 50% water that has been approved by the U.S. Food and Drug Administration for use in the symptomatic relief of patients with interstitial cystitis. Dimethyl Sulfoxide will be instilled in the bladder on an inpatient or out-patient basis, which will be determined by your physician.

Some data indicate that dimethyl sulfoxide could change the effectiveness of medication(s) that you may be presently receiving. Be sure to mention the name and dosage of all medicines you are taking to your physician before a Dimethyl Sulfoxide instillation. A garlic-like taste may be noted by the patient within a few minutes after instillation of Dimethyl Sulfoxide.

This taste may last several hours. An odor on the breath and skin may be present and remain for up to 72 hours. Some patients may experience discomfort on administration of the drug.

Usually this becomes less prominent with repeated administration. If you are pregnant or nursing, ask your physician about the advisability of using Dimethyl Sulfoxide. Some eye changes have been observed in animals treated with DMSO in large doses for prolonged periods.

Therefore your doctor may want you to have eye evaluations, including slit lamp examinations prior to and periodically during treatment. Dimethyl Sulfoxide Irrigation, USP 50% w/w Distributed by: Renova Pharmaceuticals LLC 161 Dwight Place, Fairfield, NJ 07004 Rev. 06/2026 Code: PON/DRUGS/08 22 2288

INFORMATION FOR PATIENTS (Patient Copy) Dimethyl Sulfoxide is a sterile solution of 50% dimethyl sulfoxide (DMSO) and 50% water that has been approved by the U.S. Food and Drug Administration for use in the symptomatic relief of patients with interstitial cystitis. Dimethyl Sulfoxide will be instilled in the bladder on an inpatient or out-patient basis, which will be determined by your physician.

Some data indicate that dimethyl sulfoxide could change the effectiveness of medication(s) that you may be presently receiving. Be sure to mention the name and dosage of all medicines you are taking to your physician before a Dimethyl Sulfoxide instillation. A garlic-like taste may be noted by the patient within a few minutes after instillation of Dimethyl Sulfoxide.

This taste may last several hours. An odor on the breath and skin may be present and remain for up to 72 hours. Some patients may experience discomfort on administration of the drug.

Usually this becomes less prominent with repeated administration. If you are pregnant or nursing, ask your physician about the advisability of using Dimethyl Sulfoxide. Some eye changes have been observed in animals treated with DMSO in large doses for prolonged periods.

Therefore your doctor may want you to have eye evaluations, including slit lamp examinations prior to and periodically during treatment. Distributed by: Renova Pharmaceuticals LLC 161 Dwight Place, Fairfield, NJ 07004 Rev. 06/2026

⚠️ Precautions ~1 min read ▾

PRECAUTIONS Changes in the refractive index and lens opacities have been seen in monkeys, dogs and rabbits given high doses of dimethyl sulfoxide chronically. Since lens changes were noted in animals, full eye evaluations, including slit lamp examinations, are recommended prior to and periodically during treatment. Approximately every six months patients receiving dimethyl sulfoxide should have a biochemical screening, particularly liver and renal function tests, and complete blood count.

Intravesical instillation of dimethyl sulfoxide may be harmful to patients with urinary tract malignancy because of dimethyl sulfoxide-induced vasodilation. Some data indicate that dimethyl sulfoxide potentiates other concomitantly administered medications. Dimethyl sulfoxide caused teratogenic responses in hamsters, rats and mice when administered intraperitoneally at high doses (2.5 to 12 gm/kg).

Oral or topical doses of dimethyl sulfoxide did not cause problems of reproduction in rats, mice and hamsters. Topical doses (5 gm/kg first two days, then 2.5 gm/kg - last eight days) produced terata in rabbits, but in another study, topical doses of 1.1 gm/kg days 3 through 16 of gestation failed to produce any abnormalities. There are no adequate and well controlled studies in pregnant women.

Dimethyl sulfoxide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dimethyl sulfoxide is administered to a nursing woman.

Safety and effectiveness in children have not been established. Information available to be given to the patient is reprinted at the end of this text.

🔒 Drug Abuse and Dependence 6 words ▾

DRUG ABUSE AND DEPENDENCE None known.

📄 Package Label / Principal Display Panel 32 words ▾

PRINCIPAL DISPLAY PANEL - 50 mL Vial NDC 84897-052-01 Dimethyl Sulfoxide Irrigation, USP 50% w/w 50% w/w Aqueous Solution For Irrigation Only Not for Injection Rx only 50 mL Vial containerlabel cartonlabel

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Rimso-50 (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Rimso-50. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$103.7K
Claims incl. refills
73
Beneficiaries
45
Spend / beneficiary
$2,305.48
Spend / claim
$1,421.19
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 DIMETHYL SULFOXIDE — the ingredient across all brands.

Top reported reactions

Headache48
Nausea48
Abdominal Pain41
Pyrexia39
Pain38
Dyspepsia28
Constipation27

Age at onset

Infant1
Child2
Adolescent2
Adult20
Elderly17

Reporter sex

239 reports
Male · 35%
Female · 65%

Serious outcomes

Life-threatening20
Disabling5
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 28 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

Finished prescription product
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 ✓ Available
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

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 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 Renova Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Renova Pharmaceuticals 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 84897-0013-25 · Renova 84897-0057-60 · Renova →
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.