robaxin ® and robaxin ® -750 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 methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
robaxin ® (methocarbamol), 500 mg – Adults: Initial dosage: 3 tablets q.i.d. Maintenance dosage: 2 tablets q.i.d. robaxin ® -750 (methocarbamol): 750 mg – Adults: Initial dosage: 2 tablets q.i.d. Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d. Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered.) Thereafter, the dosage can usual...
Rx Only
robaxin®/robaxin®-750 (methocarbamol tablets, USP), a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.
The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below.
Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.
robaxin® is available as a light orange, round, film-coated tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, FD&C Yellow 6, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 20, povidone, propylene glycol, saccharin sodium, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide.
robaxin®-750 is available as an orange capsule-shaped, film-coated tablet containing 750 mg of methocarbamol, USP for oral administration. In addition to the inactive ingredients present in robaxin®, robaxin®-750 also contains D&C Yellow 10.
The mechanism of action of methocarbamol in humans has not been established, but may be due to general CNS depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.
In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%.
Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine.
The mean (± SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean [± SD] age, 69 [± 4] years) was slightly prolonged compared to a younger (mean [± SD] age, 53.3 [± 8.8] years), healthy population (1.5 [± 0.4] hours versus 1.1 [±0.27] hours, respectively). The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41% to 43% versus 46% to 50%, respectively).
The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (± SD) elimination half-life in these two groups was similar: 1.2 (± 0.6) versus 1.1 (±0.3) hours, respectively.
In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects. The mean (± SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (± 1.62) hours and 1.11 (± 0.27) hours, respectively. The percent of methocarbamol bound to plasma proteins was decreased to approximately 40% to 45% compared to 46% to 50% in the normal subjects.
robaxin® and robaxin®-750 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 methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
robaxin® and robaxin®-750 are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
Since methocarbamol may possess a general CNS depressant effect, patients receiving robaxin® or robaxin®-750 should be cautioned about combined effects with alcohol and other CNS depressants.
Safe use of robaxin® and robaxin®-750 has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, robaxin® and robaxin®-750 should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS, Pregnancy).
Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.
Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.
Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.
See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol.
Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.
Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method.
Long-term studies to evaluate the carcinogenic potential of methocarbamol have not been performed. No studies have been conducted to assess the effect of methocarbamol on mutagenesis or its potential to impair fertility.
Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. robaxin® and robaxin®-750 should be given to a pregnant woman only if clearly needed.
Safe use of robaxin® and robaxin®-750 has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, robaxin® and robaxin®-750 should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see WARNINGS).
Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when robaxin® or robaxin®-750 is administered to a nursing woman.
Safety and effectiveness of robaxin® and robaxin®-750 in pediatric patients below the age of 16 have not been established.
Adverse reactions reported coincident with the administration of methocarbamol include:
Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache
Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis
Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting
Hemic and lymphatic system: Leukopenia
Immune system: Hypersensitivity reactions
Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo
Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria
Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.
In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.
Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.
robaxin® (methocarbamol), 500 mg – Adults:
Initial dosage: 3 tablets q.i.d.
Maintenance dosage: 2 tablets q.i.d.
robaxin®-750 (methocarbamol): 750 mg – Adults:
Initial dosage: 2 tablets q.i.d.
Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d.
Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered.) Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
robaxin® (methocarbamol tablets, USP)
500-mg tablets are light orange, round, film-coated tablets engraved with ROBAXIN 500 on the unscored side and SP above the score on the other side. They are supplied as follows:
Bottles of 100 NDC 52244-429-10
robaxin®-750 (methocarbamol tablets, USP)
750-mg tablets are orange, capsule-shaped, film-coated tablets engraved with ROBAXIN 750 on one side and SP on the other. They are supplied as follows:
Bottles of 100 NDC 52244-449-10
Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).
Dispense in tight container.
For more information, call Endo Pharmaceuticals Inc. at 1-800-462-3636.
Distributed by:
Endo Pharmaceuticals, Inc.
Malvern, PA 19355
Revised: 01/2019
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52244-429-10 | EA - Each | 52244-429 | cb34bc82-a3b6-43bf-8676-cc89875d1e03 | 1 | 2012-07-24 |
| 52244-449-10 | EA - Each | 52244-449 | 0b4ce1c0-c6a0-474a-b7fe-831fa30d6e0f | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Methocarbamol | ACTIVE INGREDIENT | 125OD7737X | 1 | |
| Methocarbamol | ACTIVE MOIETY | 125OD7737X | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52244-429 | 52244-429-10 |
| 52244-449 | 52244-449-10 |
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 |
|---|---|---|---|---|---|---|
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SUSPENSION / ORAL | 76 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CONCENTRATE / ORAL | 0.03 mg/5ml | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | ELIXIR / ORAL | 0.3 mg/15ml | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, ORALLY DISINTEGRATING / ORAL | 12 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED / ORAL | 131.67 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FOR SUSPENSION / ORAL | 264 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 3 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RECTAL | 665 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | CAPSULE, DELAYED RELEASE / ORAL | 150 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, DELAYED RELEASE / ORAL | 450 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | LOTION, AUGMENTED / TOPICAL | 0.2 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SOAP / TOPICAL | 1.4 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| POVIDONE | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER / ORAL | 48 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | POWDER, FOR SUSPENSION / ORAL | 1.3 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SPONGE / TOPICAL | 5 %w/w | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAMUSCULAR | 1.62 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, CHEWABLE / ORAL | 6 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 99 mg |
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 |
|---|---|---|---|---|---|---|---|
| N011011-004 | ROBAXIN | METHOCARBAMOL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011011-006 | ROBAXIN-750 | METHOCARBAMOL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |
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 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N011011-004 | ROBAXIN | 500MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N011011-006 | ROBAXIN-750 | 750MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N011011-004 | ROBAXIN | 500MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N011011-006 | ROBAXIN-750 | 750MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N011011-004 | ROBAXIN | 500MG | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N011011-006 | ROBAXIN-750 | 750MG | TABLET / ORAL | AA | RLD, RS, Approved before 1982 | 74a2ff9319b5… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N011011-006 | AA | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | N011011-006 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N011011-006 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N011011-006 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N011011-004 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N011011-006 | 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 |
|---|---|---|---|---|---|---|
| 53a60c30-a22d-42ce-8bca-761bb30f5b29 | 0db1e8dd-b4fa-491b-a529-0fb939710759 | 2019-07-18 | Warnings, Adverse reactions | 53a60c30-a22d-42ce-8bca-761bb30f5b29 0db1e8dd-b4fa-491b-a529-0fb939710759 |
Adverse event summaries are temporarily unavailable. Other product information remains available.