FDA-filed SPL labeling · retrieved through openFDA

Cyclobenzaprine

Cyclobenzaprine is a muscle relaxant used to relieve muscle spasm associated with acute, painful musculoskeletal conditions, and Tonmya (the sublingual form) is specifically indicated for the treatment of fibromyalgia in adults.

Brand names AmrixFlexerilTonmyaFexmidCyclobenzaprine Hci
Drug classes ⓘ Centrally-mediated Muscle Relaxation
Rx Forms 3 Routes Oral · Sublingual
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 224 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 effectiveNov 13, 2025
Clinical labels in scope ⓘ224
AvailabilityRx
Earliest approval/marketing year ⓘ1977
FDA-listed product records ⓘ627
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026 🚨Class I recall on record
⭐ Cyclobenzaprine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Cyclobenzaprine is a short-term muscle relaxant that works alongside rest and physical therapy to relieve muscle spasm and pain from acute musculoskeletal injuries. Tonmya, its sublingual form, is specifically approved for fibromyalgia in adults. It causes significant drowsiness, must not be combined with MAO inhibitors, and is generally not recommended for older adults or people with liver disease.
How we write & review this content — our editorial policy →

📖 Cyclobenzaprine: Patient Information Guide

A plain-language walkthrough of Cyclobenzaprine — 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▾

Cyclobenzaprine is a muscle relaxant available in several formulations with distinct approved uses.

  • Oral tablets (including Fexmid and Cyclobenzaprine Hydrochloride tablets) are used alongside rest and physical therapy to relieve muscle spasm, pain, tenderness, and limited movement caused by acute, painful musculoskeletal conditions — intended for short-term use only (up to 2–3 weeks).
  • Extended-release capsules (Amrix and Cyclobenzaprine Hydrochloride extended-release capsules) are indicated for the same short-term relief of muscle spasm from acute, painful musculoskeletal conditions, used alongside rest and physical therapy.
  • Tonmya (sublingual tablet) is separately indicated for the treatment of fibromyalgia in adults — this is a distinct approval not shared by the oral tablet or capsule forms.
  • Cyclobenzaprine in any form has not been found effective for spasticity related to central nervous system diseases (such as cerebral palsy or spinal cord disease).
⚙️How it works▾

Cyclobenzaprine works primarily in the brainstem — not directly on the muscles or at the point where nerves meet muscle fibers. It reduces the nerve signals that keep muscles in a state of excessive tension (hyperactivity), calming skeletal muscle spasm without blocking normal muscle function. It influences both the gamma and alpha motor systems — the pathways the nervous system uses to regulate muscle tone.

Structurally, cyclobenzaprine is closely related to tricyclic antidepressants and shares several of their pharmacological properties, including sedation and anticholinergic (atropine-like) effects, which explains many of its side effects and drug interactions.

💊How it's taken▾

The dose and timing depend on which formulation you are prescribed — do not assume different forms are interchangeable.

  • Oral tablets (Cyclobenzaprine Hydrochloride, Fexmid, and others): typically taken multiple times a day by mouth; older adults and those with liver problems should take lower or less frequent doses.
  • Extended-release capsules (Amrix, Cyclobenzaprine Hydrochloride ER): taken once daily by mouth at the same time each day; taking with food increases absorption. Swallow whole, or sprinkle contents on a tablespoon of applesauce and swallow without chewing — do not use other foods. Not recommended in elderly patients or anyone with liver impairment.
  • Tonmya sublingual tablets: placed under the tongue at bedtime once daily; moisten your mouth with water first. The dose starts lower for the first two weeks, then increases. Do not swallow, cut, crush, or chew.

All forms are meant for short-term use. Oral tablets and capsules are not recommended beyond 2–3 weeks. Always follow your prescriber's exact instructions.

🤒Side effects — in detail▾

The most commonly reported side effects include:

  • Dry mouth
  • Dizziness
  • Drowsiness (somnolence)
  • Fatigue
  • Constipation
  • Nausea
  • Upset stomach (dyspepsia)
  • Blurred vision
  • Headache
  • Confusion or nervousness

Drowsiness and dry mouth are the most frequently reported effects overall. Seek medical help right away if you experience signs of serotonin syndrome (confusion, fever, rapid heartbeat, muscle twitching), chest pain, irregular heartbeat, seizures, or a severe allergic reaction such as facial or tongue swelling.

⚠️Warnings & precautions▾
  • Serotonin syndrome: Combining cyclobenzaprine with SSRIs, SNRIs, tramadol, bupropion, meperidine, verapamil, tricyclic antidepressants, or MAO inhibitors can trigger a potentially life-threatening reaction. Symptoms include confusion, agitation, hallucinations, rapid heart rate, high fever, sweating, muscle rigidity, and vomiting. Stop the medication and seek emergency care immediately if these occur.
  • MAO inhibitor combination is absolutely forbidden: Using cyclobenzaprine at the same time as an MAO inhibitor — or within 14 days of stopping one — can cause hyperpyretic crisis (dangerously high fever), seizures, and death.
  • Heart effects: Because of its structural similarity to tricyclic antidepressants, cyclobenzaprine can cause heart rhythm abnormalities. It must not be used in people with certain pre-existing heart conditions.
  • Sedation and CNS depression: It strongly amplifies the effects of alcohol and sedatives — avoid driving or operating machinery until you know how it affects you.
  • Older adults: Drug levels are significantly higher and last longer in people over 65. The extended-release capsule form is not recommended in this group.
  • Liver disease: Cyclobenzaprine builds up more in people with liver impairment. Extended-release capsules are not recommended for anyone with liver disease; oral tablets require caution and lower doses in mild impairment.
🔀What it interacts with▾

Cyclobenzaprine interacts with several important drug classes — always tell your doctor and pharmacist everything you take.

  • MAO inhibitors (e.g., phenelzine, tranylcypromine, selegiline): potentially fatal — absolutely contraindicated together or within 14 days of stopping an MAO inhibitor.
  • Serotonergic drugs (SSRIs, SNRIs, tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil): serious risk of serotonin syndrome — a life-threatening condition.
  • Alcohol: cyclobenzaprine significantly increases alcohol's sedating effects.
  • Barbiturates and other CNS depressants (sedatives, sleep aids): additive sedation and CNS depression.
  • Tramadol: increases the risk of seizures in addition to serotonin syndrome risk.
  • Guanethidine and similar antihypertensive drugs: cyclobenzaprine may block their blood pressure-lowering effect.

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 take if you have had a recent heart attack, have heart rhythm problems, heart block, conduction disturbances, or congestive heart failure.
  • Do not take if you have hyperthyroidism (overactive thyroid).
  • Do not take if you are allergic to any component of the product — reactions can include hives, swelling of the face or tongue, or anaphylaxis.
  • Tell your doctor if you have liver disease — dose adjustment or avoidance may be necessary depending on severity and formulation.
  • Older adults (65+) should discuss risks carefully with their prescriber; the extended-release capsule is generally not recommended in this group.
  • Tell your doctor if you have a history of urinary retention, angle-closure glaucoma, or increased eye pressure — cyclobenzaprine's anticholinergic effects may worsen these.
  • Safety and effectiveness have not been established in children.
  • If you are pregnant or breastfeeding: limited safety data are available. Discuss the risks and benefits with your prescriber before use.
🚑If you take too much▾

Taking too much cyclobenzaprine can be serious — and deaths have occurred, especially when combined with alcohol or other drugs. The most common signs of overdose are extreme drowsiness and a fast heart rate, but more dangerous effects can include seizures, severe low blood pressure, heart rhythm problems, coma, and a rare condition called neuroleptic malignant syndrome. If an overdose is suspected, call Poison Control (1-800-222-1222) or go to an emergency room right away — do not wait for symptoms to worsen.

📡Pharmacodynamics — effects in the body▾

Cyclobenzaprine reduces excessive skeletal muscle activity by acting on the central nervous system — specifically the brainstem — rather than on the muscles or nerve-muscle junctions directly. The result is a lowering of the nerve signals that keep muscles in a state of heightened tension, relieving spasm without blocking normal muscle function. It also has anticholinergic (atropine-like) effects throughout the body, which contribute to side effects such as dry mouth, urinary retention, and increased heart rate.

🔬Pharmacokinetics — how your body processes it▾

Cyclobenzaprine is taken up into the body through the gut, with oral bioavailability of roughly one-third to just over half of the dose. Tablets reach peak blood levels faster than extended-release capsules, which peak around 7–8 hours after dosing. The drug has a long half-life — meaning it stays in the body a long time — averaging around 18 hours for tablets and up to 32 hours for the extended-release form; in older adults, the half-life can stretch even longer. It is broken down mainly by liver enzymes and eliminated through the kidneys, primarily as glucuronide compounds.

📦How to store it▾

Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) .

📄 Written from Cyclobenzaprine’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 →

197

Supplements & herbs that interact with Cyclobenzaprine

197 supplements and herbal products have documented interactions with Cyclobenzaprine 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 · 5
  • Moderate · 146
  • Minor · 46
ACTIVATED CHARCOAL Major GRAPEFRUIT Major LITHIUM Major PROCAINE Major ST. JOHN'S WORT Major 1,3-DMAA Moderate 5-HTP Moderate ACACIA RIGIDULA Moderate +189 more
Every supplement checked against Cyclobenzaprine — ranked by severity The full interaction hub: 5 major · 146 moderate · 46 minor · every one linked to its full report. Check Cyclobenzaprine 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 Cyclobenzaprine — the kind of thing our pharmacy team would talk through with you at the counter.

What is cyclobenzaprine actually used for? ▾
It's a muscle relaxant prescribed to help ease muscle spasms, pain, and stiffness from acute musculoskeletal injuries — like a back strain or a pulled muscle. It's meant to be used together with rest and physical therapy, not on its own. One specific form, Tonmya (the under-the-tongue tablet), is approved for a different condition — fibromyalgia in adults. It's designed for short-term use, generally no more than 2 to 3 weeks for the oral forms.
Will this make me really drowsy? Can I drive? ▾
Yes, drowsiness is one of the most common side effects — it's real and can be significant. You should not drive, operate heavy machinery, or do anything that requires sharp focus until you know how it affects you. Alcohol makes the drowsiness much worse, so it's best to avoid it completely while you're taking cyclobenzaprine.
Are there any medications I absolutely cannot take with this? ▾
Yes — MAO inhibitors (a type of antidepressant, like phenelzine or selegiline) must never be combined with cyclobenzaprine. The combination can cause seizures and has been fatal. You also need to be very careful with other antidepressants like SSRIs or SNRIs, tramadol, bupropion, and similar drugs because of a serious risk called serotonin syndrome. Always tell every provider and pharmacist exactly what you take — including supplements.
What is serotonin syndrome and how would I know if I have it? ▾
Serotonin syndrome happens when there's too much serotonin activity in your nervous system — usually from combining certain medications. The warning signs come on quickly and can include confusion, agitation, hallucinations, a racing heart, high fever, heavy sweating, muscle twitching or stiffness, and sometimes nausea or diarrhea. If you notice any of these after starting or changing a medication, stop taking cyclobenzaprine and go to the emergency room right away — this is a medical emergency.
I'm older — is it safe for me to take cyclobenzaprine? ▾
It needs extra caution. Older adults tend to build up higher blood levels of cyclobenzaprine, and it stays in the body longer, which raises the risk of side effects like dizziness, confusion, and falls. The extended-release capsule form is generally not recommended for people 65 and older. If you're in this group and your doctor prescribes cyclobenzaprine, make sure they know your age and discuss the right form and lowest effective dose for you.
Can I sprinkle the extended-release capsule on food if I have trouble swallowing it? ▾
Yes — but only on applesauce, and only if you can swallow the applesauce without chewing it. Sprinkle the full contents of the capsule onto a tablespoon of applesauce and swallow it right away. Then rinse your mouth to make sure you got everything down. Don't use other foods — only applesauce has been tested. And this only applies to the extended-release capsule form; don't crush or chew Tonmya sublingual tablets under any circumstances.
Is Cyclobenzaprine available over the counter? ▾
Cyclobenzaprine 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 Cyclobenzaprine first available? ▾
Cyclobenzaprine has been available in the United States since at least 1977, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Cyclobenzaprine? ▾
Cyclobenzaprine is supplied by 101 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, Remedyrepack Inc..

💬 Answers drafted from Cyclobenzaprine’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

📊Cyclobenzaprine supplement interactions197 checked — ranked by severity 🌿Drug & Supplement CheckerCyclobenzaprine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Cyclobenzaprine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Cyclobenzaprine comes

Cyclobenzaprine is available in 3 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.

Tablet

By mouth
Brands Cyclobenzaprine Hci Fexmid
How this form is used
What it may be used for
  • Used as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions
  • Fexmid is indicated for relief of muscle spasm and its associated pain, tenderness, and limitation of motion
Important instructions
  • Taken by mouth multiple times a day — follow your prescriber's instructions on frequency
  • Not recommended for use longer than 2–3 weeks
  • Fexmid: less frequent dosing should be considered for older adults or those with liver impairment
  • Cyclobenzaprine Hydrochloride tablets: lower starting doses and slower increases are advised for elderly patients and those with mild liver impairment
Available strengths 3 strengths
5 mg 7.5 mg 10 mg
525 FDA-listed product records ⓘ

Extended-release capsule

By mouth
Brands Amrix
How this form is used
What it may be used for
  • Amrix is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions
  • Cyclobenzaprine Hydrochloride extended-release capsules are indicated for the same short-term muscle spasm relief alongside rest and physical therapy
Important instructions
  • Amrix: swallow capsules whole once daily, or sprinkle contents onto a tablespoon of applesauce and swallow immediately without chewing — rinse the mouth afterward
  • Cyclobenzaprine Hydrochloride extended-release capsules: may also be sprinkled on applesauce (not other foods) for patients unable to swallow the capsule intact
  • Taking the extended-release capsule with food increases drug absorption — take consistently at the same time each day
  • Not recommended for use longer than 2–3 weeks; not recommended in elderly patients or those with any degree of liver impairment
Available strengths 2 strengths
15 mg 30 mg
71 FDA-listed product records ⓘ

Sublingual tablet

Under the tongue
Brands Tonmya
How this form is used
What it may be used for
  • Tonmya is indicated for the treatment of fibromyalgia in adults
Important instructions
  • Tonmya: place under the tongue at bedtime — do not swallow whole, cut, crush, or chew the tablet
  • Tonmya: moisten your mouth with sips of water before placing the tablet under the tongue
  • Tonmya: the dose starts lower for the first two weeks, then increases to the target dose — follow your prescriber's schedule exactly
  • Tonmya: older adults and those with mild liver impairment use a lower dose; not recommended for moderate or severe liver impairment
Available strengths 1 strength
2.8 mg
3 FDA-listed product records ⓘ

📊 Cyclobenzaprine across the U.S. market

How Cyclobenzaprine 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.

3
Dose forms ⓘ
101
Manufacturers
8
Brand names
627
FDA-listed product records ⓘ
1977
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 (21) · Kit (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack11%
A-S Medication Solutions9%
Remedyrepack Inc.9%
NuCare Pharmaceuticals,Inc.6%
PD-Rx Pharmaceuticals, Inc.4%
Proficient Rx LP4%
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 Cyclobenzaprine is used

A general measure of how commonly Cyclobenzaprine 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 Cyclobenzaprine 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.

4,437,147
Medicaid prescriptions filled (Q1–Q4 2025)
$36.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cyclobenzaprine prescribed? Of the 1,597 medications we measure, Cyclobenzaprine ranks #48 by Medicaid prescriptions — more than 97% of them.

Where Cyclobenzaprine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #48 of 1,597
#43 Aripiprazole 5,031,681 Rx #44 Diclofenac Topical (ar... 4,673,607 Rx #45 Diclofenac Topical (ac... 4,673,607 Rx #46 Diclofenac 4,673,607 Rx #47 Lamotrigine 4,467,083 Rx #48 Cyclobenzaprine 4,437,147 Rx #49 Triamcinolone Topical 4,329,207 Rx #50 Duloxetine 4,105,865 Rx #51 Methadone 4,056,849 Rx #52 Guanfacine 4,043,576 Rx #53 Lisdexamfetamine 3,941,773 Rx

Utilization by Cyclobenzaprine 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 10 mg oral tablet is the most-dispensed Cyclobenzaprine product — about 70% of these Medicaid prescriptions.

cyclobenzaprine hydrochloride 10 MG Oral Tablet Most dispensed

3,085,116 Medicaid prescriptions (Q1–Q4 2025) 70% of Cyclobenzaprine prescriptions shown $24.9M gross reimbursement (before rebates) ≈ $8.09 per prescription (gross)

Summed across the 38 of 793 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 828348

cyclobenzaprine hydrochloride 5 MG Oral Tablet

1,327,582 Medicaid prescriptions (Q1–Q4 2025) 30% of Cyclobenzaprine prescriptions shown $10.6M gross reimbursement (before rebates) ≈ $7.98 per prescription (gross)

Summed across the 27 of 420 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 828320

cyclobenzaprine hydrochloride 7.5 MG Oral Tablet

23,067 Medicaid prescriptions (Q1–Q4 2025) <1% of Cyclobenzaprine prescriptions shown $668,333 gross reimbursement (before rebates) ≈ $29 per prescription (gross)

Summed across the 6 of 226 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 828299

24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule

1,002 Medicaid prescriptions (Q1–Q4 2025) <1% of Cyclobenzaprine prescriptions shown $70,418 gross reimbursement (before rebates) ≈ $70 per prescription (gross)

Summed across the 3 of 59 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 828358

24 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral Capsule

380 Medicaid prescriptions (Q1–Q4 2025) <1% of Cyclobenzaprine prescriptions shown $37,020 gross reimbursement (before rebates) ≈ $97 per prescription (gross)

Summed across the 3 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 828353

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 Cyclobenzaprine, 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 77 of 1,523 listed Cyclobenzaprine NDCs with Medicaid activity.

🔍 Compare Cyclobenzaprine products

A representative set of FDA-listed product records for Cyclobenzaprine — 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 200 of 627 products — FDA National Drug Code Directory. See every product, package size and price: browse all 627 Cyclobenzaprine 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) Cyclobenzaprine RxCUI 21949 3 dose forms · 6 strengths
  3. Dose form (SCDF) Sublingual Tablet RxCUI 2723103 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 2.8 MG RxCUI 2723106

Look up RxCUI 21949 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

Amrix Flexeril Tonmya Fexmid Cyclobenzaprine Hci

🏭 Manufacturers & labelers

Bryant Ranch Prepack 57 A-S Medication Solutions 46 Remedyrepack Inc. 44 NuCare Pharmaceuticals,Inc. 31 PD-Rx Pharmaceuticals, Inc. 23 Proficient Rx LP 23 Asclemed USA, Inc. 23 Direct_Rx 19 Teva Pharmaceuticals USA, Inc. 17 Preferred Pharmaceuticals Inc. 14 Advanced Rx Pharmacy Of Tennessee, Llc 13 NuCare Pharmaceuticals, Inc. 11 St. Mary's Medical Park Pharmacy 10 Directrx 10 Amneal Pharmaceuticals of New York LLC 10 Direct Rx 10 RedPharm Drug, Inc. 10 RPK Pharmaceuticals, Inc. 10 Preferred Pharmaceuticals, Inc. 9 Quality Care Products, LLC 9 Advanced Rx of Tennessee, LLC 9 Cephalon, LLC 8 Redpharm Drug 7 Unit Dose Services 7

…and 16 more on the FDA NDC directory.

RxNorm drug class

Cyclobenzaprine belongs to the Muscle Relaxant class.

Pharmacologic class Muscle Relaxant
Drug family (ATC) Other centrally acting agents

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 Nov 13, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cyclobenzaprine.
📈
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 Cyclobenzaprine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
224
NDC products indexed
627
Distinct labelers/manufacturers represented
101
Linked representative label ⓘ
American Health Packaging
Linked label effective
Nov 13, 2025
Composite sections available
24
Linked SPL Set ID
269bc278-963d-4830-816a-39bb4bf8c936
Linked SPL Document ID
437e4fe5-baf0-1534-e063-6394a90a22d4
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 224 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. American Health Packaging 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.