Methocarbamol Tablets USP Rx Only

Manufacturer: Bryant Ranch Prepack
Effective date: 2024-08-20
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 26
Source: full-release
Hydrated at: 2026-05-31 21:10:58

Label at a glance#

ProductMethocarbamol

Active ingredientMETHOCARBAMOL

Label structure11 sections

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

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 C ₁₁H ₁₅NO ₅. 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.
Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

Pharmacokinetics

SPL UNCLASSIFIED SECTION

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.

Special populations

SPL UNCLASSIFIED SECTION

Elderly
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).

Renally impaired
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.

Hepatically impaired
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.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Methocarbamol tablets USP 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.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Methocarbamol tablets USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

WARNINGS

WARNINGS SECTION

Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol tablets USP should be cautioned about combined effects with alcohol and other CNS depressants.
Safe use of methocarbamol tablets USP 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, methocarbamol tablets USP 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).

Use In Activities Requiring Mental Alertness

SPL UNCLASSIFIED SECTION

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.

PRECAUTIONS

PRECAUTIONS SECTION

Information for Patients

INFORMATION FOR PATIENTS SECTION

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.

Drug Interactions

DRUG INTERACTIONS SECTION

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.

Drug & OR Laboratory Test Interactions

DRUG & OR LABORATORY TEST INTERACTIONS SECTION

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.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

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.

Pregnancy

PREGNANCY SECTION

Teratogenic effects -Pregnancy Category C
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. Methocarbamol tablets USP should be given to a pregnant woman only if clearly needed.
Safe use of methocarbamol tablets USP 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, methocarbamol tablets USP 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 ).

Nursing Mothers

NURSING MOTHERS SECTION

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 methocarbamol tablets USP are administered to a nursing woman.

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness of methocarbamol tablets USP in pediatric patients below the age of 16 have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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, urticarial

OVERDOSAGE

OVERDOSAGE SECTION

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.

Treatment

SPL UNCLASSIFIED SECTION

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.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Methocarbamol Tablets USP 500 mg – Adults:
Initial dosage: 3 tablets q.i.d.
Maintenance dosage: 2 tablets q.i.d.
Methocarbamol Tablets USP 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.

HOW SUPPLIED

HOW SUPPLIED SECTION

Methocarbamol tablets USP 500 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on scored side and ‘114’ on unscored side.

NDC: 63629-1622-1: 14 Tablets in a BOTTLE

NDC: 63629-1622-2: 30 Tablets in a BOTTLE

NDC: 63629-1622-3: 20 Tablets in a BOTTLE

NDC: 63629-1622-4: 60 Tablets in a BOTTLE

NDC: 63629-1622-5: 100 Tablets in a BOTTLE

NDC: 63629-1622-6: 40 Tablets in a BOTTLE

NDC: 63629-1622-7: 90 Tablets in a BOTTLE

NDC: 63629-1622-8: 120 Tablets in a BOTTLE

NDC: 63629-1622-9: 7 Tablets in a BOTTLE

NDC: 63629-1622-0: 15 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Methocarbamol 500mg Tablet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197943	methocarbamol 500 MG Oral Tablet	PSN	26
197943	methocarbamol 500 MG Oral Tablet	SCD	26

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
METHOCARBAMOL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
492965be-47bc-38cf-57c4-5c5e0343abe5	Product name	6	20211028
02a01e9c-3f4e-c0ee-6542-be865127aea3	Product name	8	20190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-1622-0	Methocarbamol	15 in 1 BOTTLE	TABLET	15	26
63629-1622-1	Methocarbamol	14 in 1 BOTTLE	TABLET	14	26
63629-1622-2	Methocarbamol	30 in 1 BOTTLE	TABLET	30	26
63629-1622-3	Methocarbamol	20 in 1 BOTTLE	TABLET	20	26
63629-1622-4	Methocarbamol	60 in 1 BOTTLE	TABLET	60	26
63629-1622-5	Methocarbamol	100 in 1 BOTTLE	TABLET	100	26
63629-1622-6	Methocarbamol	40 in 1 BOTTLE	TABLET	40	26
63629-1622-7	Methocarbamol	90 in 1 BOTTLE	TABLET	90	26
63629-1622-8	Methocarbamol	120 in 1 BOTTLE	TABLET	120	26
63629-1622-9	Methocarbamol	7 in 1 BOTTLE	TABLET	7	26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1622	METHOCARBAMOL (METHOCARBAMOL) TABLET [BRYANT RANCH PREPACK]	26	Current NDC, Legacy NDC, 10 package rows	20240821_add9e47f-11ac-e10d-bfc2-b9c52aa08fa5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1622-1	EA - Each	63629-1622	42b99229-4b99-4e14-8599-0f2016a258d9	1	2012-07-24
63629-1622-2	EA - Each	63629-1622	5990bc48-f4bd-4611-8637-473f262c26ef	1	2012-07-24
63629-1622-3	EA - Each	63629-1622	9152f399-cff2-444b-a603-420c80c323cd	1	2012-07-24
63629-1622-4	EA - Each	63629-1622	8dcb27cd-2702-4c30-9893-62018f18e119	1	2012-07-24
63629-1622-5	EA - Each	63629-1622	0d46fce7-f2a7-42c6-94d6-c688c15c9371	1	2015-02-02
63629-1622-6	EA - Each	63629-1622	aa3753bb-326c-4d5b-9060-449b141e471e	1	2015-02-02
63629-1622-7	EA - Each	63629-1622	ea3db8c3-1578-4176-a6ff-2b2248f99249	1	2015-02-02
63629-1622-8	EA - Each	63629-1622	6e06ddc6-472d-467e-a32b-f7d2f91e374b	1	2015-02-02
31722-533-01	EA - Each	31722-533	17d20976-d1ce-403e-be95-913cbef7fb75	1	2012-07-24
31722-533-05	EA - Each	31722-533	90619c3c-d4e8-4255-8fe4-1e0fb046205d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
METHOCARBAMOL	ACTIVE INGREDIENT	125OD7737X	5
METHOCARBAMOL	ACTIVE MOIETY	125OD7737X	5
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	5
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

Methocarbamol
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K90
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63629-1622	63629-1622-1, 63629-1622-2, 63629-1622-3, 63629-1622-4, 63629-1622-5, 63629-1622-6, 63629-1622-7, 63629-1622-8, 63629-1622-9, 63629-1622-0
31722-533

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE K90	RDH86HJV5Z	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	IACT
STEARIC ACID	4ELV7Z65AP	IACT
METHOCARBAMOL	125OD7737X	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 2 · 72 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
POVIDONE K90	POVIDONE K90	RDH86HJV5Z	TABLET / ORAL	966 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
POVIDONE K90	POVIDONE K90	RDH86HJV5Z	TABLET / ORAL	966 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
POVIDONE K90	POVIDONE K90	RDH86HJV5Z	TABLET / ORAL	966 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
POVIDONE K90	POVIDONE K90	RDH86HJV5Z	TABLET / ORAL	966 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
POVIDONE K90	POVIDONE K90	RDH86HJV5Z	TABLET / ORAL	966 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
POVIDONE K90	POVIDONE K90	RDH86HJV5Z	TABLET / ORAL	966 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
POVIDONE K90	POVIDONE K90	RDH86HJV5Z	TABLET / ORAL	966 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
POVIDONE K90	POVIDONE K90	RDH86HJV5Z	TABLET / ORAL	966 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
POVIDONE K90	POVIDONE K90	RDH86HJV5Z	TABLET / ORAL	966 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL	230 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
POVIDONE K90	POVIDONE K90	RDH86HJV5Z	TABLET / ORAL	966 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL	233 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090200-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2009-11-06
A090200-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2009-11-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090200-001	AA
A090200-002	AA

Observed Orange Book product history#

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090200-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090200-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090200-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090200-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090200-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090200-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090200-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090200-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090200-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090200-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090200-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090200-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090200-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090200-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090200-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090200-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090200-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090200-002	AA	1	`74a2ff9319b5…`

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	add9e47f-11ac-e10d-bfc2-b9c52aa08fa5	2024-08-20	Warnings, Adverse reactions	Exact identifier ndc (package): 63629-1622-7 ndc (package): 63629-1622-4 ndc (package): 63629-1622-2 ndc (package): 63629-1622-1 ndc (package): 63629-1622-5 ndc (package): 63629-1622-6 ndc (package): 63629-1622-8 ndc (package): 63629-1622-3 ndc (package): 63629-1622-0 ndc (package): 63629-1622-9 ndc (product): 63629-1622 ndc11 (package): 63629162201 ndc11 (package): 63629162200 ndc11 (package): 63629162203 ndc11 (package): 63629162205 ndc11 (package): 63629162204 ndc11 (package): 63629162206 ndc11 (package): 63629162208 ndc11 (package): 63629162207 ndc11 (package): 63629162209 ndc11 (package): 63629162202 spl id: c77bc09b-efdc-4ce5-89b8-ebb328d3599a spl set id: add9e47f-11ac-e10d-bfc2-b9c52aa08fa5
Methocarbamol	METHOCARBAMOL	Camber Pharmaceuticals, Inc.	43af0c41-9990-4902-9384-75de5ea08283	2021-04-06	Warnings, Adverse reactions	Exact identifier ndc (product): 31722-533

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.