Methocarbamol Tablets, USP

Manufacturer: Blenheim Pharmacal, Inc.
Effective date: 2015-11-04
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 20:21:25

Label at a glance#

ProductMethocarbamol

Active ingredientMETHOCARBAMOL

Label structure14 sections

Indications and uses

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.

Dosage and administration

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 ...

Contacts and useful links#

PhoneLabel contact1-888-869-8008

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

R x only
Blenheim Pharmacal, Inc.

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

PHARMACOKINETICS 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

DESCRIPTION

DESCRIPTION SECTION

Methocarbamol tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.

The chemical name of methocarbamol is 3-(2-meth-oxyphenoxy)-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.

Structure

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: povidone, sodium starch glycolate and magnesium stearate.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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/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

TERATOGENIC EFFECTS SECTION

Pregnancy Category C

SPL UNCLASSIFIED SECTION

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.

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:

SPL UNCLASSIFIED SECTION

Anaphylactic reaction, angioneurotic edema, fever, headache

Cardiovascular system:

SPL UNCLASSIFIED SECTION

Bradycardia, flushing, hypotension, syncope, thrombophlebitis

Digestive system:

SPL UNCLASSIFIED SECTION

Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting

Hemic and lymphatic system:

SPL UNCLASSIFIED SECTION

Leukopenia

Immune system:

SPL UNCLASSIFIED SECTION

Hypersensitivity reactions

Nervous system:

SPL UNCLASSIFIED SECTION

Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo

Skin and special senses:

SPL UNCLASSIFIED SECTION

Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

SPL UNCLASSIFIED SECTION

To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare at 1-888-869-8008 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 AND 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 tablets are round standard concave, scored, white to off-white tablet, debossed S 225 on one side and plain on the reverse side.

They are supplied as follows:

Bottles of 18 NDC 10544-773-18
Bottles of 20 NDC 10544-773-20
Bottles of 30 NDC 10544-773-30
Bottles of 60 NDC 10544-773-60
Bottles of 90 NDC 10544-773-90

Methocarbamol tablets, USP

750 mg tablets are modified capsule shape, white to off-white tablet, debossed S 226 on one side and plain on the reverse side.

They are supplied as follows:

Bottles of 20 NDC 10544-464-20
Bottles of 30 NDC 10544-464-30
Bottles of 40 NDC 10544-464-40
Bottles of 60 NDC 10544-464-60
Bottles of 84 NDC 10544-464-84
Bottles of 90 NDC 10544-464-90
Bottles of 100 NDC 10544-464-00
Bottles of 120 NDC 10544-464-02

STORAGE AND HANDLING SECTION

Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).
[see USP Controlled Room Temperature].
Dispense in tight container.

Manufactured for:
Solco Healthcare U.S., LLC
Cranbury, NJ 08512

Manufactured by:
Emcure Pharmaceuticals USA Inc.
21-B, Cotters Lane
East Brunswick, NJ 08816

Packaged/ Marketed by:

Blenheim Pharmacal, Inc.
North Blenheim, NY 12131, (USA)

M.F. # 0301-01
Rev. October 2012

R x only

500 mg 60s Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10544-773-60

Methocarbamol Tablets, USP

500 mg

Blenheim Pharmacal, Inc.

60 Tablets

R x only

Label 500mg 60ct

750 mg 60s Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10544-464-60

Methocarbamol Tablets, USP

750 mg

Blenheim Pharmacal, Inc.

60 Tablets

R x only

Label 750mg 60ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197943	methocarbamol 500 MG Oral Tablet	PSN	4
197944	methocarbamol 750 MG Oral Tablet	PSN	4
197943	methocarbamol 500 MG Oral Tablet	SCD	4
197944	methocarbamol 750 MG Oral Tablet	SCD	4

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-464-00	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-464-02	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-464-20	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-464-30	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-464-40	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-464-60	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-464-84	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-464-90	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-773-18	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-773-20	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-773-30	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-773-60	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP
10544-773-90	2020-01-31	C162847	48780-1	9d75b9d0-a759-f424-e053-dadaa90a57ce	Methocarbamol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10544-464-00	Methocarbamol	100 in 1 BOTTLE	TABLET	100	4
10544-464-02	Methocarbamol	120 in 1 BOTTLE	TABLET	120	4
10544-464-20	Methocarbamol	20 in 1 BOTTLE	TABLET	20	4
10544-464-30	Methocarbamol	30 in 1 BOTTLE	TABLET	30	4
10544-464-40	Methocarbamol	40 in 1 BOTTLE	TABLET	40	4
10544-464-60	Methocarbamol	60 in 1 BOTTLE	TABLET	60	4
10544-464-84	Methocarbamol	84 in 1 BOTTLE	TABLET	84	4
10544-464-90	Methocarbamol	90 in 1 BOTTLE	TABLET	90	4
10544-773-18	Methocarbamol	18 in 1 BOTTLE	TABLET	18	4
10544-773-20	Methocarbamol	20 in 1 BOTTLE	TABLET	20	4
10544-773-30	Methocarbamol	30 in 1 BOTTLE	TABLET	30	4
10544-773-60	Methocarbamol	60 in 1 BOTTLE	TABLET	60	4
10544-773-90	Methocarbamol	90 in 1 BOTTLE	TABLET	90	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-464	METHOCARBAMOL TABLET [BLENHEIM PHARMACAL, INC.]	4	Legacy NDC, 8 package rows	20151105_4cd1701a-c4f2-429a-a4db-185ece4e9a58.zip
10544-773	METHOCARBAMOL TABLET [BLENHEIM PHARMACAL, INC.]	4	Legacy NDC, 5 package rows	20151105_4cd1701a-c4f2-429a-a4db-185ece4e9a58.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-773-18	EA - Each	10544-773	41deb605-458d-483c-ad62-67211d1c1b4f	1	2015-10-02
10544-773-20	EA - Each	10544-773	adbf23d7-c3de-40e2-8809-0162c0c8e1f8	1	2015-10-02
10544-773-30	EA - Each	10544-773	f7683572-16b9-4bd8-af78-e700677bf065	1	2015-10-02
10544-773-60	EA - Each	10544-773	653014a2-a14c-49ab-8aa1-34622765d999	1	2014-08-01
10544-773-90	EA - Each	10544-773	49ef3724-be9d-43e4-b724-066c814161fc	1	2015-10-02
10544-464-00	EA - Each	10544-464	2afb942a-9dfd-46d3-8c2b-42b1ad5e9095	1	2015-10-02
10544-464-02	EA - Each	10544-464	0c69d98a-cc8e-4c42-b62e-5296eb6fe579	1	2015-10-02
10544-464-30	EA - Each	10544-464	8c723a97-869a-4e60-83fd-799b79ffd102	1	2015-10-02
10544-464-60	EA - Each	10544-464	49972ebb-79b7-49a2-91e7-6c37dca2fc43	1	2015-10-02
10544-464-90	EA - Each	10544-464	e7fe45bc-4e88-49da-948d-845b8e63389d	1	2014-08-01
43547-225-10	EA - Each	43547-225	5ee46d94-9972-4be9-ae1f-1d7b021fda56	1	2013-03-03
43547-225-50	EA - Each	43547-225	31d3e586-da52-47e0-a231-51c391736aa7	1	2013-03-03
43547-226-10	EA - Each	43547-226	a2160aa6-1049-44c7-b919-116d25c4050c	1	2013-03-03
43547-226-50	EA - Each	43547-226	004e67fc-bc05-4042-9860-0c46b1a6990b	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
METHOCARBAMOL	ACTIVE INGREDIENT	125OD7737X	4
METHOCARBAMOL	ACTIVE MOIETY	125OD7737X	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	4

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Methocarbamol
POVIDONES
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10544-773	10544-773-18, 10544-773-20, 10544-773-30, 10544-773-60, 10544-773-90
10544-464	10544-464-20, 10544-464-30, 10544-464-40, 10544-464-60, 10544-464-84, 10544-464-90, 10544-464-00, 10544-464-02
43547-225
43547-226

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POVIDONES	FZ989GH94E	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
METHOCARBAMOL	125OD7737X	ACTIB
POVIDONES	FZ989GH94E	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
MAGNESIUM STEARATE	70097M6I30	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 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POVIDONES	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii+route+dosage form
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form

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 · 2 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
A086988-001	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982
A086988-002	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086988-001	AA
A086988-002	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 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086988-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086988-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A086988-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A086988-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086988-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A086988-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086988-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086988-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086988-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086988-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086988-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086988-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086988-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086988-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086988-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086988-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086988-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086988-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086988-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086988-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086988-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086988-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086988-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086988-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086988-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086988-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086988-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086988-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086988-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086988-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086988-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086988-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086988-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086988-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086988-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086988-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086988-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086988-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086988-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086988-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086988-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086988-001	AA	1	`5aa47cf7b7d7…`

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086989-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086989-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086989-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086989-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086989-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086989-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086989-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086989-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086989-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086989-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086989-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086989-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086989-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086989-001	AA	1	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A086989-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086989-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086989-001	AA	1	`cb3db0bc1861…`

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	Solco Healthcare LLC	32863f21-30ff-4a8b-a2e6-8ab14a37af0d	2025-09-25	Warnings, Adverse reactions	Exact identifier ndc (product): 43547-226
23cd352d-9463-4cbe-e054-00144ff88e88			4cd1701a-c4f2-429a-a4db-185ece4e9a58	2015-11-04	Warnings, Adverse reactions	Exact identifier spl id: 23cd352d-9463-4cbe-e054-00144ff88e88 spl set id: 4cd1701a-c4f2-429a-a4db-185ece4e9a58

Reported adverse events (FAERS/openFDA)#

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