Chlorzoxazone 375 mg Tablet, 100-count — NDC 0254-2053-01 (Billing 00254-2053-01)
This is a package of 100 tablets of Chlorzoxazone 375 mg Tablet from Par Health USA, LLC, marketed since Jun 2021 and currently FDA-listed; retail pharmacies pay about $0.6665 per tablet (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0254-2053-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0254 labeler · 2053 product · 01 package
- Package marketed since
- Jun 17, 2021
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 100 EA per package
- Barcode (UPC)
- 0302542053019, 0302542005018
- Medicaid fills, this package
- 460 prescriptions in the last four reported quarters
- FDA record last changed
- Sep 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 068025
- GCN: 30715
- HICL (First Databank): 001941
- AHFS class code: 12:20.04.00
- RxCUI (RxNorm): 1088934
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Muscle Relaxant class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Chlorzoxazone is used to relieve pain and stiffness caused by muscle strains and sprains. It is used in combination with physical therapy, analgesics (such as aspirin or acetaminophen), and rest.
Read the full MedlinePlus article ↗- It helps relieve discomfort from sudden, painful muscle and bone conditions. It is meant to be used along with rest, physical therapy and other measures, not by itself.
- You take it by mouth, usually three or four times a day. Your doctor may adjust the amount depending on how you respond, and it can often be lowered as you get better. Follow the d...
- Most people tolerate it well. Some feel drowsy, dizzy, lightheaded or a bit unwell, and a few feel over-stimulated. Your urine may change color, which isn't known to be a problem.
- Rarely, it can harm the liver. Stop the medicine and call if you have fever, rash, nausea, vomiting, unusual tiredness, upper right belly pain, dark urine or yellow skin or eyes. S...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Chlorzoxazone — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.667 | $66.65 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $1.82 | $182.16 / 100 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00254-2053-01 You're viewing this Main listing | 100 TABLET in 1 BOTTLE | 2021-06-17 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Chlorzoxazone 375 mgthis 00254-2053-01 | Par | 100 tablets | $0.667 | AB | Availability likely | — |
| Chlorzoxazone 375 mg 16571-0725-01 | Rising | 100 tablets | $0.667 | AB | Availability likely | — |
| Chlorzoxazone 375 mg 59651-0305-01 | Aurobindo | 100 tablets | $0.667 | — | Availability likely | — |
| Chlorzoxazone 375 mg 80425-0525-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
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.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 656HXR6YXN
A combination of two additives: docusate sodium softens the medicine's texture to help it break apart, while sodium benzoate acts as a preservative to prevent spoilage and maintain shelf life.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Par Health USA, LLC labeler code 00254
- Colchicine .6 mg Capsule NDC 0254-0460-01
- Diazoxide 50 mg/mL Suspension NDC 0254-1010-19
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- penicillamine 250 mg Tablet, Film Coated NDC 0254-2000-01
- Chlorzoxazone 750 mg Tablet NDC 0254-2005-01
- Posaconazole 100 mg Tablet, Coated NDC 0254-2045-02
- Omega-3-acid ethyl esters 900 mg Capsule NDC 0254-3010-08
- Alvimopan 12 mg Capsule NDC 0254-3012-55
- Nitisinone 2 mg Capsule NDC 0254-3020-02
- Nitisinone 5 mg Capsule NDC 0254-3021-02
- Nitisinone 10 mg Capsule NDC 0254-3022-02
- Lubiprostone 8 ug Capsule, Gelatin Coated NDC 0254-3028-02
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Chlorzoxazone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Usual Adult Dosage Chlorzoxazone tablets USP 375 mg: One tablet three or four times daily. If adequate response is not obtained with this dose, the 375 mg tablets may be increased to two tablets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.
Chlorzoxazone tablets 750 mg: 1/3 tablet (250 mg) three or four times daily. Initial dosage for painful musculoskeletal conditions should be 2/3 tablet (500 mg) three or four times daily. If adequate response is not obtained with this dose, it may be increased to one tablet (750 mg) three or four times daily.
As improvement occurs dosage can usually be reduced.
⛔ Contraindications ▾
CONTRAINDICATIONS Chlorzoxazone tablets are contraindicated in patients with known intolerance to the drug.
⚠️ Warnings ▾
WARNINGS Serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone. The mechanism is unknown but appears to be idiosyncratic and unpredictable. Factors predisposing patients to this rare event are not known.
Patients should be instructed to report early signs and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice. Chlorzoxazone should be discontinued immediately and a physician consulted if any of these signs or symptoms develop. Chlorzoxazone use should also be discontinued if a patient develops abnormal liver enzymes (e.g., AST, ALT, alkaline phosphatase and bilirubin).
The concomitant use of alcohol or other central nervous system depressants may have an additive effect. Usage in Pregnancy: The safe use of chlorzoxazone tablets has not been established with respect to the possible adverse effects upon fetal development. Therefore, it should be used in women of childbearing potential only when, in the judgment of the physician, the potential benefits outweigh the possible risks.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Chlorzoxazone containing products are usually well tolerated. It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding. Drowsiness, dizziness, light-headedness, malaise, or overstimulation may be noted by an occasional patient.
Rarely, allergic-type skin rashes, petechiae, or ecchymoses may develop during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is no evidence that the drug will cause renal damage.
Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone. This finding is of no known clinical significance.
🆘 Overdosage ▾
OVERDOSAGE Symptoms: Initially, gastrointestinal disturbances such as nausea, vomiting, or diarrhea together with drowsiness, dizziness, lightheadedness or headache may occur. Early in the course there may be malaise or sluggishness followed by marked loss of muscle tone, making voluntary movement impossible. The deep tendon reflexes may be decreased or absent.
The sensorium remains intact, and there is no peripheral loss of sensation. Respiratory depression may occur with rapid, irregular respiration and intercostal and substernal retraction. The blood pressure is lowered, but shock has not been observed.
Treatment: Gastric lavage or induction of emesis should be carried out, followed by administration of activated charcoal. Thereafter, treatment is entirely supportive. If respirations are depressed, oxygen and artificial respiration should be employed and a patent airway assured by use of an oropharyngeal airway or endotracheal tube.
Hypotension may be counteracted by use of dextran, plasma, concentrated albumin or a vasopressor agent such as norepinephrine. Cholinergic drugs or analeptic drugs are of no value and should not be used.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Chlorzoxazone is a centrally-acting agent for painful musculoskeletal conditions. Data available from animal experiments as well as human study indicate that chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. The clinical result is a reduction of the skeletal muscle spasm with relief of pain and increased mobility of the involved muscles.
Blood levels of chlorzoxazone can be detected in people during the first 30 minutes and peak levels may be reached, in the majority of the subjects, in about 1 to 2 hours after oral administration of chlorzoxazone. Chlorzoxazone is rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the glucuronide. Less than one percent of a dose of chlorzoxazone is excreted unchanged in the urine in 24 hours.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Chlorzoxazone tablets USP are supplied as follows: Chlorzoxazone tablets USP 375 mg are a white capsule shaped tablet, debossed “PAR” on the one side and “375” on another side. Free of physical defects. Bottles of 100 tablets NDC 0254-2053-01 Chlorzoxazone tablets USP 750 mg are a white capsule shaped tablet, debossed “PAR” on the trisected side (functional scoring) and “750” on the bisected side (functional scoring).
Bottles of 100 tablets NDC 0254-2005-01 Dispense in tight container as defined in the official compendium. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured for: Par Health USA Woodcliff Lake, NJ 07677 U.S.A. Product of Taiwan Made in India Neutral Code: TN/DRUGS/TN00002121 © 2026 Par Health, Inc. or one of its affiliates. OS2053-01-74-04 Revised: 07/2026
📋 Description ▾
DESCRIPTION Each 375 mg chlorzoxazone tablet USP contains: Chlorzoxazone USP 375 mg. Each 750 mg chlorzoxazone tablet USP contains: Chlorzoxazone USP 750 mg. Chemical Name: 5-Chloro-2-benzoxazolinone.
Structural Formula: Molecular Formula: C 7 H 4 CINO 2 Molecular Weight: 169.56 Chlorzoxazone USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Inactive ingredients: anhydrous lactose, corn starch, croscarmellose sodium, DSS granular (docusate sodium 85% with sodium benzoate 15%), magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). chem-stru
⚠️ Precautions ▾
PRECAUTIONS Chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped. If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued.
📄 Package Label / Principal Display Panel ▾
PACKAGE.LABEL.PRINCIPAL DISPLAY PANEL Chlorzoxazone Tablets USP 375 mg - 100's Count Container Label Chlorzoxazone Tablets USP 750 mg - 100's Count Container Label 375_mg_-_100s_Tablets_-_Par_Health.jpg 750_mg_-_100s_Tablets_-_Par_Health.jpg