Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see DOSAGE AND ADMI...
The recommended dose of Carisoprodol Tablets is 350 mg three times a day and at bedtime. The recommended maximum duration of Carisoprodol Tablets use is up to two or three weeks.
www.fda.gov/medwatchCarisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol Tablets should
only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [
see
DOSAGE AND ADMINISTRATION (2)
]
.
The recommended dose of Carisoprodol Tablets is 350 mg three times a day and at bedtime. The recommended maximum duration of Carisoprodol Tablets use is up to two or three weeks.
Carisoprodol Tablets, USP 350 mg are white, round, unscored tablets; imprinted "WW 176".
Carisoprodol Tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reactions to a carbamate such as meprobamate
Carisoprodol Tablets have sedative properties (in the low back pain trials, 13% to 17% of patients who received Carisoprodol tablets experienced sedation compared to 6% of patients who received placebo) [see ADVERSE REACTIONS (6.1)] and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. There have been post-marketing reports of motor vehicle accidents associated with the use of Carisoprodol Tablets.
Since the sedative effects of Carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.
In the postmarketing experience with Carisoprodol Tablets, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in patients who have had a history of addiction or who used Carisoprodol tablets in combination with other drugs with abuse potential. However, there have been post-marketing adverse event reports of Carisoprodol Tablets-associated abuse when used without other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of Carisoprodol dependence, withdrawal, or abuse, Carisoprodol tablets should be used with caution in addictionprone patients and in patients taking other CNS depressants including alcohol, and Carisoprodol should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.
Carisoprodol Tablets, and one of its metabolites, meprobamate (a controlled substance), may cause dependence [see Clinical Pharmacology (12.3) ].
There have been postmarketing reports of seizures in patients who received Carisoprodol Tablets. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol) [see Overdosage (10)].
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.
The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain [see Clinical Studies (14)]. In the study, patients were treated with 350 mg of Carisoprodol Tablets, or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74% Caucasian, 16% Black, 9% Asian, and 2% other.
There were no deaths and there were no serious adverse reactions in these two trials. In the study, 2.7% and 5.4%, of patients treated with placebo and 350 mg of Carisoprodol Tablets, respectively, discontinued due to adverse events; and 0.5% and 1.8% of patients treated with placebo and 350 mg of Carisoprodol Tablets, respectively, discontinued due to central nervous system adverse reactions.
Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with Carisoprodol Tablets in the trial described above.
Table 1 – Patients with Adverse Reactions in Controlled Studies
| Adverse Reaction |
Placebo
(n=560) n(%) |
Carisoprodol 350 mg
(n=279) n(%) | |
| Drowsiness | 31(6) | 47(17) | |
| Dizziness | 11(2) | 19(7) | |
| Headache | 11(2) | 9(3) | |
The following events have been reported during postapproval use of Carisoprodol Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular: Tachycardia, postural hypotension, and facial flushing [see Overdosage (10)].
Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [see Overdosage (10)].
Gastrointestinal: Nausea, vomiting, and epigastric discomfort.
Hematologics: Leukopenia, pancytopenia
The sedative effects of Carisoprodol Tablets and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of Carisoprodol and meprobamate, a metabolite of Carisoprodol, is not recommended [see Warnings and Precautions (5.1)].
Carisoprodol Tablets are metabolized in the liver by CYP2C19 to form meprobamate [see Clinical Pharmacology (12.1)]. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with Carisoprodol Tablets could result in increased exposure of carisoprodol and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John"s Wort, with Carisoprodol Tablets could result in decreased exposure of carisoprodol and increased exposure of meprobamate. Low dose aspirin also showed induction effect on CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of Carisoprodol Tablets is unknown.
There are no data on the use of Carisoprodol Tablets during human pregnancy. Animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations.
Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of carisoprodol. There was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. Across studies that indicated an increased risk, the types of malformations were inconsistent.
Nonteratogenic effects: In animal studies, carisoprodol reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1-1.5 times the human dose (based on a body surface area comparison). Rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. For children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or IQ scores. Carisoprodol Tablets should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
There is no information about the effects of Carisoprodol Tablets on the mother and the fetus during labor and delivery.
Very limited data in humans show that Carisoprodol Tablets are present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed infant received about 4-6% of the maternal daily dose through breast milk and experienced no adverse effects. However, milk production was inadequate and the baby was supplemented with formula. In lactation studies in mice, female pup survival and pup weight at weaning were decreased. This information suggests that maternal use of Carisoprodol Tablets may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when Carisoprodol Tablets are administered to a nursing woman.
The efficacy, safety, and pharmacokinetics of Carisoprodol Tablets in pediatric patients less than 16 years of age have not been established.
The efficacy, safety, and pharmacokinetics of Carisoprodol Tablets in patients over 65 years old have not been established.
The safety and pharmacokinetics of Carisoprodol Tablets in patients with renal impairment have not been evaluated. Since
Carisoprodol Tablets are excreted by the kidney, caution should be exercised if Carisoprodol Tablets are administered to patients with impaired renal function. Carisoprodol Tablets are dialyzable by hemodialysis and peritoneal dialysis.
The safety and pharmacokinetics of carisoprodol in patients with hepatic impairment have not been evaluated. Since Carisoprodol Tablets are metabolized in the liver, caution should be exercised if Carisoprodol Tablets are administered to patients with impaired hepatic function.
Patients with reduced CYP2C19 activity have higher exposure to Carisoprodol Tablets. Therefore, caution should be exercised in administration of Carisoprodol Tablets to these patients. [see Clinical Pharmacology (12.3)].
Carisoprodol Tablets are not a controlled substance [see Warnings and Precautions (5.2)]. Discontinuation of carisoprodol in animals or in humans after chronic administration can produce withdrawal signs, and there are published case reports of human carisoprodol dependence.
In vitro studies demonstrate that carisprodol elicits barbiturate-like effects. Animal behavior studies indicate that carisoprodol produces rewarding effects. Monkeys self administer carisoprodol. Drug discrimination studies using rats indicate that carisoprodol has positive reinforcing and discriminative effects similar to barbital, meprobamate, and chlordiazepoxide.
Overdosage of Carisoprodol Tablets commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures, delirium, hallucinations, dystonic reactions, nystagmus, blurred vision, mydriasis, euphoria, muscular incoordination, rigidity, and/or headache have been reported with Carisoprodol Tablets overdosage. Many of the Carisoprodol Tablets overdoses have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol). The effects of an overdose of Carisoprodol Tablets and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) can be additive even when one of the drugs has been taken in the recommended dosage. Fatal accidental and non-accidental overdoses of carisoprodol have been reported alone or in combination with CNS depressants.
Treatment of Overdosage: Basic life support measures should be instituted as dictated by the clinical presentation of the Carisoprodol Tablets overdose. Induced emesis is not recommended due to the risk of CNS and respiratory depression, which may increase the risk of aspiration pneumonia. Gastric lavage should be considered soon after ingestion (within one hour). Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.
The following types of treatment have been used successfully with an overdose of meprobamate, a metabolite of carisoprodol: activated charcoal (oral or via nasogastric tube), forced diuresis, peritoneal dialysis, and hemodialysis (carisoprodol is also dialyzable). Careful monitoring of urinary output is necessary and overhydration should be avoided. Observe for possible relapse due to incomplete gastric emptying and delayed absorption. For more information on the management of an overdose of carisoprodol, contact a Poison Control Center.
The mechanism of action of carisoprodol in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified.
In animal studies, muscle relaxation induced by carisoprodol is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.
Carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles.
A metabolite of carisoprodol, meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprobamate contribute to the safety and efficacy of Carisoprodol Tablets is unknown.
The pharmacokinetics of carisoprodol and its metabolite meprobamate were studied in a crossover study of 24 healthy subjects (12 male and 12 female) who received single doses of 350 mg Carisoprodol (see Table 2). The C max of meprobamate was 2.5 ± 0.5 μg/mL (mean ± SD) after administration of a single 350 mg dose of carisoprodol, which is approximately 30% of the C max of meprobamate (approximately 8 μg/mL) after administration of a single 400 mg dose of meprobamate.
Table 2. Pharmacokinetic Parameters of Carisoprodol and Meprobamate (Mean ± SD, n=24)
| 350 mg Carisoprodol | ||
| Carisoprodol | ||
| C max(µg/mL) | 1.8 ± 1.0 | |
| AUC inf (µg*hr/mL) | 7.0 ± 5.0 | |
| T max (hr) | 1.7 ± 0.8 | |
| T 1/2 (hr) | 2.0 ± 0.5 | |
| Meprobamate | ||
| C max(µg/mL) | 2.5 ± 0.5 | |
| AUC inf (µg*hr/mL) | 46 ± 9.0 | |
| T max (hr) | 4.5 ± 1.9 | |
| T 1/2 (hr) | 9.6 ± 1.5 | |
Absorption: Absolute bioavailability of carisoprodol has not been determined. The mean time to peak plasma concentrations (T max) of carisoprodol was approximately 1.5 to 2 hours. Co-administration of a high-fat meal with Carisoprodol (350 mg tablet) had no effect on the pharmacokinetics of carisoprodol. Therefore, Carisoprodol Tablets may be administered with or without food.
Metabolism: The major pathway of carisoprodol metabolism is via the liver by cytochrome enzyme CYP2C19 to form meprobamate. This enzyme exhibits genetic polymorphism (see Patients with Reduced CYP2C19 Activity below).
Elimination: Carisoprodol is eliminated by both renal and non-renal routes with a terminal elimination half-life of approximately 2 hours. The half-life of meprobamate is approximately 10 hours.
Gender: Exposure of carisoprodol is higher in female than in male subjects (approximately 30-50% on a weight adjusted basis). Overall exposure of meprobamate is comparable between female and male subjects.
Patients with Reduced CYP2C19 Activity: Carisoprodol Tablets should be used with caution in patients with reduced CYP2C19 activity. Published studies indicate that patients who are poor CYP2C19 metabolizers have a 4-fold increase in exposure to carisoprodol, and concomitant 50% reduced exposure to meprobamate compared to normal CYP2C19 metabolizers. The prevalence of poor metabolizers in Caucasians and African Americans is approximately 3-5% and in Asians is approximately 15-20%.
Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol.
Carisoprodol Tablets were not formally evaluated for genotoxicity. In published studies, carisoprodol was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes. Carisoprodol was clastogenic in the in vitro chromosomal aberration assay using Chinese hamster ovary cells with or without the presence of metabolizing enzymes. Other types of genotoxic tests resulted in negative findings. Carisoprodol was not mutagenic in the Ames reverse mutation assay using S. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating blood cells.
Carisoprodol was not formally evaluated for effects on fertility. Published reproductive studies of carisoprodol in mice found no alteration in fertility although an alteration in reproductive cycles characterized by a greater time spent in estrus was observed at a carisoprodol dose of 1200 mg/kg/day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/day. In both studies, the no effect level was 750 mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison. The significance of these findings for human fertility is not known.
The safety and efficacy of Carisoprodol Tablets for the relief of acute, idiopathic mechanical low back pain was evaluated in one, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trials (Study 1). Patients had to be 18 to 65 years old and had to have acute back pain (≤ 3 days of duration) to be included in the trials. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.
In Study 1, patients were randomized to one of three treatment groups (i.e., Carisoprodol Tablets 350 mg, or placebo). In the study patients received study medication three times a day and at bedtime for seven days.
The primary endpoints were the relief from starting backache and the global impression of change, as reported by patients, on Study Day 3. Both endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome) in both studies. The primary statistical comparison was between the Carisoprodol 250 mg and placebo groups in both studies.
The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups.
The results for the primary efficacy evaluations in the acute, low back pain studies are presented in Table 3.
Table 3. Results of the Primary Efficacy Endpoints* in Study 1
| Study | Parameter | Placebo |
Carisoprodol Tablets 350 mg | |
| 1 | Number of Patients | n=269 | n=273 | |
| Relief for Starting Backache, Mean (SE)† | 1.4(0.1) | 1.8 (0.1) | ||
| Difference between Carisoprodol and Placebo, Mean (SE)† (95% CI) | 0.4
(0.2, 0.6) | |||
| Global Impression of Change, Mean (SE)† | 1.9(0.1) | 2.2 (0.1) | ||
| Difference between Carisoprodol and Placebo, Mean (SE)† (95% CI) |
0.3
| |||
*The primary efficacy endpoints (Relief from Starting Backache and Global Impression of Change) were assessed by the patients on Study Day #3. These endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome).
†Mean is the least squared mean and SE is the standard error of the mean.
Patients treated with Carisoprodol Tablets experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.
Carisoprodol Tablets, USP 350 mg, are white, round, unscored tablets; imprinted "WW 176", are available in:
Bottles of 100 tablets
Bottles of 500 tablets
Bottles of 1000 tablets
Store at 20-25
oC (68-77
oF) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Patients should be advised to contact their physician if they experience any adverse reactions to Carisoprodol Tablets.
Patients should be advised that Carisoprodol Tablets may cause drowsiness and/or dizziness, and have been associated with motor vehicle accidents. Patients should be advised to avoid taking Carisoprodol Tablets before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [see Warnings and Precautions (5.1)]
Patients should be advised to avoid alcoholic beverages while taking Carisoprodol Tablets and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives [see Warnings and Precautions (5.1) ].
Patients should be advised that treatment with Carisoprodol Tablets should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. In the post-marketing experience with Carisoprodol Tablets, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation.
Manufactured for:
West-ward Pharmaceutical Corp
Eatontown, NJ 07724
Manufactured by:
Shasun Chemical and Drugs Ltd.
Pondicherry, India
Revised August 2010 020000823
Carisoprodol Tablets are available as 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol in chloroform, and in acetone; its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisioprodol is N-isopropyl-2-methyl-2-propyl-1,3- propanediol dicarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:
Other Ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, methylcellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid.
Carisoprodol Tablets, USP 350mg CIV
30 Tablets
NDC 10544-132-30
| Class | Version | Type | Effective |
|---|---|---|---|
| CARISOPRODOL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0310544132304 | GTIN-13: 0310544132304 EAN-13: 0310544132304 GTIN-12: 310544132304 UPC-A: 310544132304 GTIN storage (14 digits): 00310544132304 | LABEL_CARISOPRODOL TABS 350MG_BPI(10544-132-30)_WEST-WARD(0143-9749-10)_REV0.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 780d53a1-1665-e26e-d112-85333c0c8a2e | Product name | 5 | 20220516 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10544-132-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-237f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10544-132-30 | Carisoprodol | 30 in 1 BOTTLE | TABLET | 30 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10544-132-30 | EA - Each | 10544-132 | f022e4cf-69a8-4c81-b5c7-23f9b0f2230d | 1 | 2015-10-02 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CARISOPRODOL | ACTIVE INGREDIENT | 21925K482H | 1 | |
| CARISOPRODOL | ACTIVE MOIETY | 21925K482H | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| METHYLCELLULOSE (4000 CPS) | INACTIVE INGREDIENT | MRJ667KA5E | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10544-132 | 10544-132-30 |
| 0143-9749 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / TOPICAL | 214 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER / ORAL | 50 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, EXTENDED RELEASE / ORAL | 320 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SUSPENSION / ORAL | 705 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | POWDER / RESPIRATORY (INHALATION) | NA | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, DELAYED RELEASE / ORAL | 199 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / SUBLINGUAL | 1.1 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 214 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE, DENTIFRICE / DENTAL | 1.4 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE / DENTAL | 1.5 %w/w | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INSERT / VAGINAL | 2282 mg | ||
| METHYLCELLULOSE (4000 CPS) | METHYLCELLULOSE (4000 MPA.S) | MRJ667KA5E | SOLUTION/ DROPS / OPHTHALMIC | 0.5 %w/v |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040124-001 | CARISOPRODOL | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | AA | 1996-01-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | AA | 1996-01-24 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | AA | 1996-01-24 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | AA | 1996-01-24 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A040124-001 | CARISOPRODOL | 350MG | TABLET / ORAL | 1996-01-24 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A040124-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A040124-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040124-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040124-001 | AA | 1 | ea99ee380514… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 117c82a6-2095-566b-e054-00144ff88e88 | 117c82a6-2094-566b-e054-00144ff88e88 | 2015-03-17 | Warnings, Adverse reactions | 117c82a6-2095-566b-e054-00144ff88e88 117c82a6-2094-566b-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.