Methocarbamol Tablets

Manufacturer: Blenheim Pharmacal, Inc.
Effective date: 2015-10-06
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:21:13

Label at a glance#

ProductMethocarbamol

Active ingredientMETHOCARBAMOL

Label structure12 sections

Indications and uses

Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of 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

500 mg – Adults: Initial dosage, 3 tablets four times a day; maintenance dosage, 2 tablets four times a day. 750 mg – Adults: Initial dosage, 2 tablets four times a day; maintenance dosage, 1 tablet every four hours or 2 tablets three times a day. 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 usua...

Contacts and useful links#

PhoneLabel contact1-877-233-2001

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

METHOCARBAMOL TABLETS, USP

Rev. 04/15

Rx Only

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 structural formula is:

Structure

The chemical name for 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.

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.

Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.

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.

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

Methocarbamol Tablets 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 should be cautioned about combined effects with alcohol and other CNS depressants.

Safe use of Methocarbamol Tablets 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 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 should be given to a pregnant woman only if clearly needed.

Safe use of Methocarbamol Tablets has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congential abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol Tablets 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 are administered to a nursing woman.

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness of Methocarbamol Tablets 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, urticaria

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-233-2001, or the 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

500 mg – Adults: Initial dosage, 3 tablets four times a day; maintenance dosage, 2 tablets four times a day.
750 mg – Adults: Initial dosage, 2 tablets four times a day; maintenance dosage, 1 tablet every four hours or 2 tablets three times a day.

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 500 mg: White, Round Tablets; Debossed "West-ward 290" on one side and Scored on the other side.

   Bottles of 100 tablets
   Bottles of 500 tablets
   Bottles of 1000 tablets

Methocarbamol Tablets 750 mg: White, Capsule Shaped Tablets; Debossed "WEST-WARD 292" on one side and Scored on the other side.

   Bottles of 100 tablets
   Bottles of 500 tablets
   Bottles of 1000 tablets

Store at 20 ^o to 25 ^oC (68 ^o to 77 ^oF) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured by:
West-Ward Pharmaceutical Corp.
Eatontown, NJ 07724

Revised April 2015

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blenheim Pharmacal, Inc.
NDC 10544-259-20
Methocarbamol Tablets, USP

750 mg
20 Tablets
Rx Only

Label 750mg 20ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197944	methocarbamol 750 MG Oral Tablet	PSN	3
197944	methocarbamol 750 MG Oral Tablet	SCD	3

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0310544259209	GTIN-13: 0310544259209 EAN-13: 0310544259209 GTIN-12: 310544259209 UPC-A: 310544259209 GTIN storage (14 digits): 00310544259209	LABEL_METHOCARBAMOL TABS 750MG _BPI(10544-259-20)_WESTWARD(0143-1292-05)_REV0.jpg
Data code	Code 128	BP00000000		LABEL_METHOCARBAMOL TABS 750MG _BPI(10544-259-20)_WESTWARD(0143-1292-05)_REV0.jpg

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
10544-259-20	2020-01-31	C162847	48780-1	9d75b9d0-b5fc-f424-e053-dadaa90a57ce	Methocarbamol Tablets
10544-259-60	2020-01-31	C162847	48780-1	9d75b9d0-b5fc-f424-e053-dadaa90a57ce	Methocarbamol Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-259-20	Methocarbamol	20 in 1 BOTTLE	TABLET	20		3
10544-259-60	Methocarbamol	60 in 1 BOTTLE	TABLET	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-259	METHOCARBAMOL TABLET [BLENHEIM PHARMACAL, INC.]	3	Legacy NDC, 2 package rows	20151006_415499a7-3417-410c-aa49-c8172d9faf6e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-259-20	EA - Each	10544-259	786da118-dd6e-47a0-9027-db1f561ce6ed	1	2015-02-02
0143-1292-01	EA - Each	0143-1292	1bba3b86-7404-4f74-811a-db6021b6b526	1	2012-07-24
0143-1292-05	EA - Each	0143-1292	61582194-362f-419c-adb1-1ee34424a8f5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
METHOCARBAMOL	ACTIVE INGREDIENT	125OD7737X	3
METHOCARBAMOL	ACTIVE MOIETY	125OD7737X	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	3
METHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	4GFU244C4J	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	3

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Methocarbamol
METHYLCELLULOSE (100 MPA.S)
LACTOSE MONOHYDRATE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10544-259	10544-259-20, 10544-259-60
0143-1292

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
METHYLCELLULOSE (100 MPA.S)	4GFU244C4J	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
STARCH, CORN	O8232NY3SJ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	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 3 · 148 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	750 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CREAM / VAGINAL		586 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, EXTENDED RELEASE / ORAL		5364 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS		214 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL		4384 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INHALANT / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	690 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	107 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, ORALLY DISINTEGRATING / ORAL		366 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		520 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE / ORAL		8946 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, COATED PELLETS / ORAL		265 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 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 · 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
A085123-001	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982
A085123-002	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982

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 · 46 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	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A085123-002	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085123-002	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085123-001	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A085123-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A085123-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085123-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085123-001	AA	1	`ea99ee380514…`

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
2026-02-19 14:30 UTC	2026-02	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		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
2019-12-13 00:20 UTC	2019-12	A085159-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A085159-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085159-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085159-001	AA	1	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
21742a02-2fe3-2b9d-e054-00144ff88e88			415499a7-3417-410c-aa49-c8172d9faf6e	2015-10-06	Warnings, Adverse reactions	Exact identifier spl id: 21742a02-2fe3-2b9d-e054-00144ff88e88 spl set id: 415499a7-3417-410c-aa49-c8172d9faf6e

Reported adverse events (FAERS/openFDA)#

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