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Methylene Blue

Methylene blue is a dye-based medicine given by vein (IV) in a medical setting to treat acquired methemoglobinemia, a condition where the blood can't carry oxygen well.

Brand names ProvayblueArthcal 1% METHYLENE BLUEOzipco 1% METHYLENE BLUE
Drug classes Oxidation-reduction Activity
Rx/OTC Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 14 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 8, 2026
Methylene Blue at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Methylene blue is a dye given by vein as the first-choice treatment for acquired methemoglobinemia (blood that carries oxygen poorly); the body turns it into leucomethylene blue, which restores hemoglobin's iron to its oxygen-carrying form, and the injection, on the market since about 2016, is available generically. Most people tolerate its one or two doses well, though urine turns blue and headache or nausea can occur. Its boxed warning is for serotonin syndrome, which can be fatal with SSRI or SNRI antidepressants, MAOIs and opioids, so give your care team your full medication list. It is not given in pregnancy or with G6PD deficiency, an inherited enzyme shortage.

Clinical pearls

  • A pulse oximeter (finger oxygen clip) can read falsely low after methylene blue, so a blood test may be used instead.
  • Avoid serotonin-boosting medicines, including dextromethorphan cough medicines, linezolid and bupropion, for 72 hours after the last dose.
  • Report tiredness, paleness or dark urine in the following days, since red blood cell breakdown can show up late.
  • Stop breastfeeding during treatment and for up to 8 days afterward.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Methylene blue injection can cause serious or even fatal serotonin syndrome when used with certain medicines. These include SSRI and SNRI antidepressants, MAOIs and opioids.

Serotonin syndrome is a dangerous buildup of serotonin activity. Warning signs include agitation, hallucinations, confusion, fast heartbeat, sweating, fever, tremor, muscle stiffness or twitching, seizures, nausea, vomiting and diarrhea. Tell your care team about every medicine you take before treatment.

Read the full warning on DailyMed →
How you get itPrescription and over the counter
Comes asInjection, Oral solution
Earliest FDA record2016
Companies listing it with the FDA15
FDA label last updatedMay 28, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Methylene Blue, written from its FDA label.

What Methylene Blue is used for

▾

Methylene blue injection is used for one main medical condition.

  • Provayblue and other methylene blue injection products (intravenous): acquired methemoglobinemia in children and adults.
  • Arthcal 1% and Ozipco 1% METHYLENE BLUE (extracorporeal solutions): the label gives mixing directions with water or use per research protocols, not a medical indication.

How Methylene Blue works

▾

Methylene blue is a water-soluble dye. The body first converts it into leucomethylene blue. That form restores the iron in methemoglobin to its normal state, turning it back into working hemoglobin that can carry oxygen.

Methylene Blue dosage

▾

Methylene blue injection is given into a vein by a healthcare professional, usually over about 5 to 30 minutes. It is never given under the skin.

  • A second dose may be given one hour later if methemoglobin stays high or symptoms persist.
  • If the condition doesn't resolve after 2 doses, other treatments are considered.
  • People with moderate or severe kidney impairment get a single dose.
  • The injection may be diluted in 5% dextrose to reduce pain at the site, particularly in children.

Because it's given in a medical setting, missed doses are not a concern. Arthcal and Ozipco solutions are mixed with water as directed on their labels.

Dosing details from the FDA-approved label

From the Methylene Blue prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Methemoglobinemia (general patients)
    • 1 mg/kg intravenously over 5-30 minutes
    • If the methemoglobin level remains greater than 30% or if clinical signs and symptoms persist, a repeat dose of 1 mg/kg may be given one hour after the first dose
    • If methemoglobinemia does not resolve after 2 doses, consider alternative interventions; do not administer subcutaneously
  • Patients with moderate or severe renal impairment (eGFR 15-59 mL/min/1.73 m2)
    • Single dose of 1 mg/kg
    • If methemoglobin level remains greater than 30% or clinical symptoms persist 1 hour after dosing, consider alternative interventions
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Administer 1 mg/kg intravenously over 5-30 minutes. ( 2.1 ) If methemoglobin level remains above 30% or if clinical symptoms persist, give a repeat dose of up to 1 mg/kg one hour after the first dose.( 2.1 ) Administer a single dose of 1 mg/kg in patients with moderate or severe renal impairment. ( 2.2 ) 2.1 Dosage and Administration Ensure patent venous access prior to administration of methylene blue injection. Do not administer methylene blue injection subcutaneously. Administer methylene blue injection 1 mg/kg intravenously over 5-30 minutes. If the methemoglobin level remains greater than 30% or if clinical signs and symptoms persist, a repeat dose of methylene blue injection 1 mg/kg may be given one hour after the first dose. If methemoglobinemia does not resolve after 2 doses of methylene blue injection, consider initiating alternative interventions for treatment of methemoglobinemia. 2.2 Recommended Dosage for Renal Impairment The recommended dosage of methylene blue injection in patients with moderate or severe renal impairment (eGFR 15-59 mL/min/1.73 m 2 ) is a single dose of 1 mg/kg. If the methemoglobin level remains greater than 30% or if the clinical symptoms persist 1 hour after dosing, consider initiating alternative interventions for the treatment of methemoglobinemia. 2.3 Preparation Methylene blue injection is hypotonic and may be diluted before use in a solution of 50 mL 5% Dextrose Injection in order to avoid local pain, particularly in the pediatric population. Use the diluted solution immediately after preparation. Avoid diluting with sodium chloride solutions, because it has been demonstrated that chloride reduces the solubility of methylene blue. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard unused portion. 2.4 Instructions for Use of prefilled syringe Remove the Pre-filled Syringe from the carton Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it contains particulate matter. Figure 1 3. Hold the syringe upright on the Luer Lock part/luer cover of the syringe barrel. With the other hand, take hold of the cap/closure and gently turn anti-clockwise as shown in the figure 2.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Methylene Blue side effects

▾

The most common side effects in studies were:

Common side effects

  • Headache
  • Nausea
  • Diarrhea
  • Low potassium (hypokalemia)
  • Low magnesium (hypomagnesemia)
  • Muscle jerks (myoclonus)
  • Seizure-like episodes

When to get medical help

  • Get help right away for signs of serotonin syndrome: agitation, hallucinations, confusion, fast heartbeat, sweating, fever, tremor, muscle stiffness or twitching, seizures, vomiting or diarrhea.
  • Get help right away for signs of a severe allergic reaction: swelling, hives, wheezing or trouble breathing.
  • Tell your care team about unusual tiredness, paleness or dark urine in the days after treatment, since anemia from red blood cell breakdown (hemolysis) can be delayed by a day or more.
  • Report confusion, dizziness or vision changes.
  • Tell your care team if your methemoglobinemia doesn't improve after 2 doses or comes back.

Methylene Blue warnings and precautions

▾
  • Serotonin syndrome (boxed warning): can be fatal with SSRIs, SNRIs, MAOIs, opioids and other serotonin-boosting drugs.
  • Allergic reactions, including anaphylaxis, have been reported.
  • Hemolytic anemia: red blood cells can break down, sometimes a day or more after treatment, and may require transfusion.
  • Possible lack of effect: it may not work well for methemoglobinemia caused by aniline or dapsone, or in G6PD deficiency.
  • False pulse oximeter readings: oxygen levels may read falsely low.
  • Dizziness, confusion and vision changes: avoid driving or machinery until these pass.
  • Blue urine can interfere with urine tests that use a blue indicator.

Methylene Blue interactions

▾

Methylene blue acts like a monoamine oxidase inhibitor, so it can clash with many drugs that raise serotonin.

  • SSRIs and SNRIs: risk of serious or fatal serotonin syndrome.
  • MAOIs: same risk.
  • Bupropion, buspirone, clomipramine, mirtazapine and linezolid: also raise serotonin activity.
  • Opioids and dextromethorphan: can increase serotonin syndrome risk.
  • Avoid serotonin-boosting drugs for 72 hours after the last dose.
  • If use together can't be avoided, the lowest dose is chosen and you are watched closely for up to 4 hours.

Interactions listed in the FDA-approved label

From the Methylene Blue prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Serotonergic drugs (SSRIs, SNRIs, MAOIs, bupropion, buspirone, clomipramine, mirtazapine, linezolid, opioids, dextromethorphan): Concomitant use with drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome, with potential for serious CNS reactions including potentially fatal serotonin syndrome; methylene blue is a potent reversible inhibitor of monoamine oxidase. Avoid concomitant use; if intravenous use cannot be avoided, choose the lowest possible dose and observe the patient closely for CNS effects for up to 4 hours after administration.
Read the label’s full interactions text

7. DRUG INTERACTIONS Clinically significant drug interactions with methylene blue injection are described below: The concomitant use of methylene blue injection with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Although the mechanism is not clearly understood, literature reports suggest methylene blue injection is a potent reversible inhibitor of monoamine oxidase. Avoid concomitant use of methylene blue injection with medicinal products that enhance serotonergic transmission including antidepressants like SSRIs (selective serotonin reuptake inhibitors), SNRIs (serotonin and norepinephrine reuptake inhibitors), MAOIs (monoamine oxidase inhibitors), bupropion, buspirone, clomipramine, mirtazapine, linezolid, opioids, and dextromethorphan because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome. If the intravenous use of methylene blue injection cannot be avoided in patients treated with serotonergic medicinal products, choose the lowest possible dose and observe the patient closely for CNS effects for up to 4 hours after administration [see Warning and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )] .

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Methylene Blue against a supplement or herb →

Before taking Methylene Blue

▾
  • Pregnancy: methylene blue can cause fetal harm and is contraindicated in women who are or may become pregnant.
  • Breastfeeding: stop during treatment and for up to 8 days afterward.
  • G6PD deficiency: can cause severe red blood cell breakdown, and it may not work.
  • Past severe allergic reaction to a methylene blue product: should not be used.
  • Kidney impairment: moderate or severe impairment means a single dose; older adults get the fewest doses needed.
  • Liver impairment: longer monitoring is needed because the drug clears more slowly.
  • Children, including newborns: used for acquired methemoglobinemia based on case series.

Methylene Blue overdose

▾

Large doses can cause low blood pressure, wheezing, nausea, vomiting, chest pain, shortness of breath, fast heartbeat, tremor, confusion and blue staining of the skin and urine. Very high doses can cause severe red blood cell breakdown and death. Treatment is observation, monitoring of the heart, lungs, blood and nervous system, and supportive care.

What Methylene Blue does in the body

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Low concentrations of methylene blue speed up the conversion of methemoglobin to hemoglobin. It also stains tissues. At an IV dose studied in a thorough QT study, it had no effect on heart rhythm measurements (QT, PR or QRS intervals).

How your body processes Methylene Blue

▾

Methylene blue is highly bound to proteins in the blood (about 94%) and has a half-life of about 24 hours. The liver breaks it down mainly by attaching sugar-like groups (conjugation), with some help from CYP enzymes. About 40% leaves in the urine unchanged. Kidney impairment raises the amount of drug in the body.

How to store Methylene Blue

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Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Do not refrigerate or freeze. protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Methylene Blue: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Methylene Blue — the kind of thing our pharmacy team would talk through with you at the counter.

What is methylene blue injection used for?

▾
It treats acquired methemoglobinemia, a condition where your blood can't carry oxygen well. It's used in both adults and children. It's given in a medical setting, so your care team handles the dosing.

How will I get it?

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It's given slowly into a vein, usually over 5 to 30 minutes. A second dose may be given an hour later if needed. It must never be injected under the skin.

Can I take it with my antidepressant or pain medicine?

▾
This is the big one. Methylene blue can cause serious or even fatal serotonin syndrome when combined with SSRIs, SNRIs, MAOIs, opioids and some other drugs. Tell your care team about everything you take, and avoid serotonin-boosting drugs for 72 hours after your last dose.

What side effects should I expect?

▾
Headache, nausea and diarrhea are common. Some people have low potassium or magnesium, muscle jerks or seizure-like episodes. Your urine may turn blue, which is expected.

When should I call for help?

▾
Get help right away for confusion, hallucinations, fever, tremor, stiff muscles, seizures, swelling or trouble breathing. Also report unusual tiredness, paleness or dark urine in the days afterward, since anemia can show up late.

Is it safe in pregnancy or while breastfeeding?

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It can cause fetal harm and is contraindicated in women who are or may become pregnant. If you're breastfeeding, you should stop during treatment and for up to 8 days afterward.

Is Methylene Blue available over the counter?

▾
Both. Some Methylene Blue products are sold over the counter and others need a prescription. According to their FDA listings, the oral solution form is sold over the counter and the injection form needs a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Methylene Blue first available?

▾
The earliest FDA record we hold for Methylene Blue is from 2016: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Methylene Blue was first used.

Who makes Methylene Blue?

▾
15 companies currently list Methylene Blue products in the FDA's NDC Directory, including American Regent, Inc., Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Methylene Blue on HelloPharmacist

🌿Drug & Supplement CheckerMethylene Blue vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Methylene Blue NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Methylene Blue Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Methylene Blue forms and strengths (how it comes)

Methylene Blue is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Methylene Blue inactive ingredients by manufacturer.

Injection

Into a vein
Brands Provayblue
How this form is used
What it may be used for
  • Provayblue is used to treat acquired methemoglobinemia in children and adults.
  • Methylene blue injection products are labeled for acquired methemoglobinemia in children and adults.
Important instructions
  • Provayblue is given into a vein over about 5 to 30 minutes and must not be given under the skin.
  • Provayblue may be diluted in 5% dextrose to reduce local pain, and sodium chloride solutions should be avoided.
  • Provayblue may be repeated once after one hour if methemoglobin stays high or symptoms persist.
Available strengths 3 strengths
5 mg/mL 10 mg/mL 50 mg/10 mL
38 FDA-listed product records ⓘ

Oral solution

Extracorporeal
Brands Arthcal 1% METHYLENE BLUE Ozipco 1% METHYLENE BLUE
How this form is used
Important instructions
  • Arthcal 1% and Ozipco 1% METHYLENE BLUE directions say to mix 1 mL (20 drops) of the solution with 200 mL of water, or use according to established research protocols.
Available strengths 1 strength
1 g/100 mL
2 FDA-listed product records ⓘ

Methylene Blue on the U.S. market: products, makers and brands

How Methylene Blue appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

15 companies list 25 Methylene Blue product records with the FDA, mostly as injection, oral solution; the earliest marketing or approval year on record is 2016. Brand names on the directory include Provayblue, Arthcal 1% METHYLENE BLUE, Ozipco 1% METHYLENE BLUE; the rest are generics.

2
Dose forms ⓘ
15
Labelers (makers, repackagers, distributors)
4
Brand names
25
FDA-listed product records ⓘ
2016
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (33) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

American Regent, Inc.16%
Zydus Lifesciences Limited12%
Zydus Pharmaceuticals USA Inc.12%
Amneal Pharmaceuticals LLC8%
Bpi Labs Llc8%
Steriscience Specialties Private Limited8%
Other makers36%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Methylene Blue is used (Medicaid data)

A general measure of how commonly Methylene Blue is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Methylene Blue is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

582
Medicaid prescriptions filled (Q1–Q4 2025)
$32,925 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Methylene Blue prescribed? Of the 1,601 medications we measure, Methylene Blue ranks #1,352 by Medicaid prescriptions — more than 16% of them.

Where Methylene Blue ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,352 of 1,601
#1,347 Estrogen and Bazedoxif... 608 Rx #1,348 Molnupiravir 597 Rx #1,349 Amikacin Oral Inhalati... 597 Rx #1,350 Apraclonidine Ophthalm... 593 Rx #1,351 Tiopronin 587 Rx #1,352 Lamivudine and Zidovud... 582 Rx #1,353 Ifosfamide Injection 582 Rx #1,354 Methylene Blue 582 Rx #1,355 Loteprednol Etabonate... 571 Rx #1,356 Alosetron 566 Rx #1,357 Cabazitaxel Injection 554 Rx

Utilization by Methylene Blue product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

10 ML methylene blue 5 MG/ML Injection

582 Medicaid prescriptions (Q1–Q4 2025) 100% of Methylene Blue prescriptions shown $32,925 gross reimbursement (before rebates) ≈ $57 per prescription (gross)

Summed across the 2 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1788984

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Methylene Blue, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 26 listed Methylene Blue NDCs with Medicaid activity.

Compare Methylene Blue products

A representative set of FDA-listed product records for Methylene Blue — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 25 of 25 products — FDA National Drug Code Directory. See every product, package size and price: browse all 25 Methylene Blue NDCs →

Methylene Blue side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Methylene Blue — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Methylene Blue are serotonin syndrome, drug interaction, hypotension; about 89% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

1,774
Reports mentioning it
89%
Reported as serious
12
Distinct effects shown
Most reported effects
Serotonin Syndrome
469
Drug Interaction
360
Hypotension
208
Toxicity To Various Agents
140
Overdose
107
Intentional Overdose
100
Encephalopathy
83
Acute Kidney Injury
79
Toxic Encephalopathy
76
Confusional State
75
Age groups
Adult · 188Elderly · 49Infant · 7Adolescent · 7Neonate · 3Child · 3

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Methylene Blue in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Methylene Blue FDA approval history

How Methylene Blue went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Methylene Blue was first approved by the FDA in 2016 (Brand: PROVAYBLUE · Provepharm Sas); the first generic version was approved in 2023. It remains available in U.S. pharmacies today.

2016
Brand approved
Brand: PROVAYBLUE · Provepharm Sas
2023
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Methylene Blue recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Methylene Blue recalls since July 2021.

✅No Methylene Blue recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Methylene Blue RxCUI 6878 5 dose forms · 9 strengths
  2. Dose form (SCDF) Oral Solution RxCUI 385008 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 248834
  3. Dose form (SCDF) Oral Tablet RxCUI 372856 No current FDA listing
    Clinical drug / strength (SCD) 65 MG RxCUI 197964
  5. Dose form (SCDF) Topical Solution RxCUI 385023 No current FDA listing
    Clinical drug / strength (SCD) 20 MG/ML RxCUI 198751

Look up RxCUI 6878 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Methylene Blue brand names

Methylene Blue is sold under 3 brand names in the FDA directory — Provayblue, Arthcal 1% METHYLENE BLUE, Ozipco 1% METHYLENE BLUE. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Provayblue Arthcal 1% METHYLENE BLUE Ozipco 1% METHYLENE BLUE

Who makes Methylene Blue: manufacturers and labelers

15 companies list Methylene Blue products with the FDA. By number of product records, the largest are American Regent, Inc., Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

American Regent, Inc. 4 Zydus Lifesciences Limited 3 Zydus Pharmaceuticals USA Inc. 3 Amneal Pharmaceuticals LLC 2 Bpi Labs Llc 2 Steriscience Specialties Private Limited 2 Beijing JUNGE Technology Co., Ltd. 1 Chengdu Shuode Pharmaceutical Co., Ltd 1 Fast Sold LLC 1 Glenmark Pharmaceuticals Inc., Usa 1 Hikma Pharmaceuticals USA Inc. 1 Meitheal Pharmaceuticals Inc. 1 Nexus Pharmaceuticals, LLC 1 OLIC (Thailand) Limited 1 Xiromed, Llc 1

Methylene Blue drug class (RxNorm)

Methylene Blue belongs to the Oxidation-Reduction Agent class.

Pharmacologic class Oxidation-Reduction Agent
Drug family (ATC) Antidotes, Tests for gastric secretion
How it works Oxidation-Reduction Activity

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Methylene Blue page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 28, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Methylene Blue.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Methylene Blue after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
14
Finished products in the current FDA directory
25
Companies listing them (makers, repackagers, distributors)
15
FDA labeler codes behind them ⓘ
15
Linked representative label ⓘ
American Regent, Inc.
Linked label effective
May 28, 2025
Composite sections available
25
Linked SPL Set ID
4f6848e5-35ed-4046-b13c-3032b5ba3232
Linked SPL Document ID
420bd985-ac55-44b9-b8a0-a5098220575b
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. American Regent, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →