FDA-filed SPL labeling · retrieved through openFDA

Orphenadrine

Orphenadrine is a muscle discomfort reliever used alongside rest and physical therapy for acute, painful musculoskeletal conditions.

Brand names DisipalNorflex
Drug class Muscle Relaxant
Rx Forms 2 Routes Oral · Intramuscular; Intravenous · Intramuscular, Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 21 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 →

At a glance
Linked label effectiveAug 10, 2026
Clinical labels in scope 21
AvailabilityRx
Earliest approval/marketing year 1957
FDA-listed product records 63
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Orphenadrine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Orphenadrine citrate helps relieve discomfort from acute, painful musculoskeletal conditions when combined with rest and physical therapy. It works best as part of a broader plan — not on its own. Because it has anticholinergic effects, side effects like dry mouth, dizziness, and blurred vision are common, so use it carefully and report anything concerning to your doctor.

📖 Orphenadrine: Patient Information Guide

A plain-language walkthrough of Orphenadrine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Orphenadrine citrate is approved to help relieve discomfort from acute, painful musculoskeletal conditions — always as part of a broader plan alongside rest and physical therapy.

  • Orphenadrine Citrate extended-release tablet: relief of discomfort associated with acute, painful musculoskeletal conditions (taken by mouth)
  • Orphenadrine Citrate injection: relief of discomfort associated with acute, painful musculoskeletal conditions (given by a healthcare professional intravenously or intramuscularly)
⚙️How it works

The exact way orphenadrine relieves discomfort isn't fully known — its benefit may be related to pain-relieving (analgesic) properties rather than directly loosening tight muscles. It also has anticholinergic activity, meaning it blocks certain signals in the nervous system. This nerve-blocking effect contributes to both some of its relief and many of its common side effects, like dry mouth and blurred vision.

💊How it's taken

Orphenadrine citrate is available as an extended-release tablet taken by mouth or as an injection given by a healthcare professional. The extended-release tablet is generally taken once in the morning and once in the evening. The injection is given intravenously or intramuscularly and can be repeated every 12 hours as needed.

  • Extended-release tablet: taken twice daily by mouth
  • Injection: administered by a healthcare provider every 12 hours as needed; oral tablets may then be used to maintain relief

Always take this medication exactly as your prescriber has directed. Do not adjust your dose without checking first.

🤒Side effects — in detail

Most side effects from orphenadrine are related to its anticholinergic (nerve-blocking) activity and tend to be more common at higher doses.

  • Dry mouth — usually the first side effect noticed
  • Dizziness or lightheadedness
  • Blurred vision or dilated pupils
  • Rapid or pounding heartbeat (tachycardia, palpitations)
  • Nausea, vomiting, or stomach irritation
  • Constipation
  • Drowsiness or headache
  • Difficulty starting to urinate

Reducing the dose often makes these side effects go away. However, get medical help right away if you experience hallucinations, severe confusion, fainting, or signs of an allergic reaction such as rash, swelling, or difficulty breathing.

⚠️Warnings & precautions
  • Dizziness and fainting: Some people feel lightheaded or may faint. Avoid driving or operating heavy machinery until you know how this drug affects you.
  • Sulfite allergy risk with the injection: Orphenadrine Citrate injection contains sodium metabisulfite, which can cause severe allergic reactions — including life-threatening anaphylaxis and serious asthma attacks — especially in people with asthma or sulfite sensitivity.
  • Rare serious blood condition: Very rare cases of aplastic anemia (where the bone marrow fails to produce enough blood cells) have been reported with orphenadrine tablets. No definite cause-and-effect link has been proven, but it is worth knowing.
  • Confusion in older adults: Elderly patients may experience mental confusion. Caregivers should watch for this, especially when starting the medication.
  • Anaphylaxis with injection: Rare but serious allergic reactions have occurred with intramuscular injection. Seek emergency help immediately if signs appear.
🔀What it interacts with

The FDA label for orphenadrine does not specify particular drug or food interactions.

    This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

    📋Before taking it
    • Do not use if you have glaucoma (high pressure in the eye)
    • Do not use if you have a blockage in your stomach or intestines (pyloric or duodenal obstruction, or a stenosing peptic ulcer)
    • Do not use if you have an enlarged prostate (prostatic hypertrophy) or a blocked bladder neck
    • Do not use if you have cardiospasm or megaesophagus (a condition where the esophagus is abnormally enlarged or doesn't work properly)
    • Do not use if you have myasthenia gravis (a disease causing muscle weakness)
    • Do not use if you have had an allergic reaction to orphenadrine before
    • Tell your provider if you have asthma or are sensitive to sulfites before receiving the injection form
    • Older adults should use with extra care — confusion is more likely in this group
    🚑If you take too much

    Taking too much orphenadrine is dangerous and can trigger severe anticholinergic effects — symptoms caused by blocking too many nerve signals throughout the body. The minimum lethal dose in adults has been reported to be 2 to 3 grams, though the range of toxicity is unpredictable. If an overdose is suspected, emergency treatment may include removing stomach contents when appropriate, repeated doses of activated charcoal, and close medical monitoring to manage any serious symptoms that arise.

    📡Pharmacodynamics — effects in the body

    Orphenadrine does not directly relax tight skeletal muscles in people. Its relief of musculoskeletal discomfort is thought to come mainly from its analgesic (pain-relieving) properties. It also blocks certain signals in the autonomic nervous system (anticholinergic activity), which accounts for side effects like dry mouth, blurred vision, and urinary hesitancy.

    📦How to store it

    Store at 20°-25°C (68°-77°F) . Dispense in a tight, light-resistant container.

    📄 Written from Orphenadrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

    35

    Supplements & herbs that interact with Orphenadrine

    35 supplements and herbal products have documented interactions with Orphenadrine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

    Severity mix
    • Major · 2
    • Moderate · 22
    • Minor · 11
    Every supplement checked against Orphenadrine — ranked by severity The full interaction hub: 2 major · 22 moderate · 11 minor · every one linked to its full report. Check Orphenadrine against your exact supplements

    Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

    🩺 Pharmacist Counseling Corner

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

    What exactly does orphenadrine do — does it just relax my muscles?
    It's a common assumption, but orphenadrine actually doesn't directly relax tense muscles. Researchers believe its benefit comes from pain-relieving properties — so it helps you feel less discomfort, which in turn may help your muscles feel less strained. It's always meant to work alongside rest and physical therapy, not replace them.
    How should I take the extended-release tablet?
    Take one extended-release tablet in the morning and one in the evening — that's twice a day. Try to stick to the same times each day. If you're unsure whether to take it with food or not, check your prescription label or ask your pharmacist, and always follow exactly what your doctor has prescribed.
    What side effects should I expect, and which ones should make me call the doctor?
    The most common ones are dry mouth, dizziness, blurred vision, drowsiness, and constipation — these are usually more bothersome at higher doses and often improve if the dose is lowered. What you want to call about right away: fainting, a racing heartbeat that worries you, hallucinations, confusion, or any signs of a serious allergic reaction like swelling, hives, or trouble breathing.
    Is it safe to drive or go to work while taking this?
    Be cautious until you know how orphenadrine affects you. It can cause dizziness, lightheadedness, or drowsiness — and in some people, even brief fainting spells. Until you're confident those effects aren't happening to you, it's wise to avoid driving or operating heavy machinery.
    Are there any health conditions that mean I shouldn't take this medication?
    Yes — orphenadrine is not right for everyone. You should not take it if you have glaucoma, an enlarged prostate, a bladder blockage, certain stomach or intestinal obstructions, a condition called myasthenia gravis (a muscle weakness disease), or if you've had an allergic reaction to it before. Make sure your prescriber knows your full health history before starting it.
    What should I do if I think I've taken too much?
    An overdose of orphenadrine is a medical emergency — call 911 or go to the nearest emergency room immediately. You can also call Poison Control at 1-800-222-1222. Too much of this drug can cause severe and dangerous effects throughout your body, and it needs to be treated by medical professionals right away.
    Is Orphenadrine available over the counter?
    Orphenadrine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
    When was Orphenadrine first available?
    Orphenadrine has been available in the United States since at least 1957, based on FDA approval history (Drugs@FDA) and product marketing records.
    Who makes Orphenadrine?
    Orphenadrine is supplied by 32 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, Advanced Rx Pharmacy of Tennessee, LLC.

    💬 Answers drafted from Orphenadrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

    🧰 Keep exploring

    💊 How Orphenadrine comes

    Orphenadrine 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.

    Extended-release tablet

    By mouth
    How this form is used
    What it may be used for
    • Orphenadrine Citrate extended-release tablet is used to relieve discomfort from acute, painful musculoskeletal conditions as part of a plan that includes rest and physical therapy
    Important instructions
    • Orphenadrine Citrate extended-release tablet is taken by mouth twice daily — one tablet in the morning and one in the evening
    • Orphenadrine Citrate extended-release tablet may be used to maintain relief after initial treatment with the injection form
    • Follow your prescriber's directions closely — do not adjust your dose on your own
    Available strengths 1 strength
    49 FDA-listed product records

    Injection

    Into a muscle · Into a vein
    How this form is used
    What it may be used for
    • Orphenadrine Citrate injection is used to relieve discomfort from acute, painful musculoskeletal conditions as part of a treatment plan including rest and physical therapy
    Important instructions
    • Orphenadrine Citrate injection is given by a healthcare professional into a vein (intravenously) or into a muscle (intramuscularly)
    • Orphenadrine Citrate injection may be repeated every 12 hours as directed
    • Orphenadrine Citrate injection should be inspected visually for particles or discoloration before use
    • Orphenadrine Citrate injection contains sodium metabisulfite — tell your provider if you have asthma or sulfite sensitivity before receiving it
    Available strengths 2 strengths
    7 FDA-listed product records

    📊 Orphenadrine across the U.S. market

    How Orphenadrine 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.

    2
    Dose forms
    32
    Manufacturers
    2
    Brand names
    63
    FDA-listed product records
    1957
    First marketed

    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 (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

    Bryant Ranch Prepack10%
    A-S Medication Solutions8%
    Advanced Rx Pharmacy of Tennessee, LLC8%
    St. Mary's Medical Park Pharmacy6%
    Preferred Pharmaceuticals, Inc.6%
    Proficient Rx LP5%
    Other makers57%

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

    📈 How widely Orphenadrine is used

    A general measure of how commonly Orphenadrine 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 Orphenadrine 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.

    91,158
    Medicaid prescriptions filled (Q1–Q4 2025)
    $1.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

    How commonly is Orphenadrine prescribed? Of the 1,596 medications we measure, Orphenadrine ranks #525 by Medicaid prescriptions — more than 67% of them.

    Where Orphenadrine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

    Utilization by Orphenadrine 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.

    The 100 mg 12 hr extended release oral tablet is the most-dispensed Orphenadrine product — about 73% of these Medicaid prescriptions.

    12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet Most dispensed

    66,639 Medicaid prescriptions (Q1–Q4 2025) 73% of Orphenadrine prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $19 per prescription (gross)

    Summed across the 3 of 115 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 994521

    2 ML orphenadrine citrate 30 MG/ML Injection

    24,519 Medicaid prescriptions (Q1–Q4 2025) 27% of Orphenadrine prescriptions shown $440,174 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

    Summed across the 4 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 994541

    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 Orphenadrine, 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 7 of 123 listed Orphenadrine NDCs with Medicaid activity.

    🔍 Compare Orphenadrine products

    A representative set of FDA-listed product records for Orphenadrine — 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 63 of 63 products — FDA National Drug Code Directory. See every product, package size and price: browse all 63 Orphenadrine NDCs →

    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) Orphenadrine RxCUI 7715 4 dose forms · 6 strengths
    1. Dose form (SCDF) Extended Release Oral Tablet RxCUI 373158 In current FDA listings
      Clinical drug / strength (SCD) 12 HR orphenadrine citrate 100 MG RxCUI 994521
    2. Dose form (SCDF) Oral Solution RxCUI 373159 No current FDA listing
      Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 994837 hydrochloride 5 MG/ML RxCUI 994847
    3. Dose form (SCDF) Oral Tablet RxCUI 373157 No current FDA listing
      Clinical drug / strength (SCD) citrate 100 MG RxCUI 994841 hydrochloride 50 MG RxCUI 994824

    Look up RxCUI 7715 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.

    🏷️ Sold under these brand names

    Disipal Norflex

    🏭 Manufacturers & labelers

    Bryant Ranch Prepack 6 A-S Medication Solutions 5 Advanced Rx Pharmacy of Tennessee, LLC 5 St. Mary's Medical Park Pharmacy 4 Preferred Pharmaceuticals, Inc. 4 Proficient Rx LP 3 PD-Rx Pharmaceuticals, Inc. 3 Remedyrepack Inc. 3 Direct_Rx 2 Hikma Pharmaceuticals USA Inc. 2 Lake Erie Medical DBA Quality Care Products LLC 2 Lupin Pharmaceuticals, Inc. 2 NuCare Pharmaceuticals, Inc. 2 Denton Pharma, Inc. DBA Northwind Pharmaceuticals 2 RPK Pharmaceuticals, Inc. 1 Sagent Pharmaceuticals 1 RedPharm Drug, Inc. 1 RedPharm Drug 1 Sandoz Inc 1 R.L.Fine Chem Private Limited 1 W. R. Grace & Co.-conn. 1 Professional Compounding Centers of America dba PCCA 1 Professional Compounding Centers of America 1 PROCOS S.p.A. 1

    …and 8 more on the FDA NDC directory.

    RxNorm drug class

    Orphenadrine belongs to the Muscle Relaxant class.

    Pharmacologic class Muscle Relaxant
    Drug family (ATC) Ethers chemically close to antihistamines, Ethers, chemically close to antihistamines

    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.

    🔬 Where this comes from

    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 Aug 10, 2026
    🏭
    Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Orphenadrine.
    📈
    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 Orphenadrine after exact ingredient or ingredient-combination matching and applicable route/form matching
    Clinical labels in scope
    21
    NDC products indexed
    63
    Distinct labelers/manufacturers represented
    32
    Linked representative label
    Remedyrepack Inc.
    Linked label effective
    Aug 10, 2026
    Composite sections available
    13
    Linked SPL Set ID
    7905e80f-b60b-48e8-8e63-a3e50211bfe4
    Linked SPL Document ID
    58b04f1a-5563-1f8a-e063-6294a90ae8cb
    Open the linked representative label on DailyMed ↗

    How we combine label and product data

    HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 21 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

    For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Remedyrepack Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

    This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.