FDA.reportPublic FDA data

METHOCARBAMOL

Manufacturer
DirectRX
Effective date
2019-04-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 20:28:14

Label at a glance#

ProductMETHOCARBAMOL
Active ingredientMETHOCARBAMOL
Label structure4 sections

Label contents#

Full prescribing information#

Special Populations

USE IN SPECIFIC POPULATIONS 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.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

610-60610-60

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

903-90903-90

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197943methocarbamol 500 MG Oral TabletPSN4
197944methocarbamol 750 MG Oral TabletPSN4
197943methocarbamol 500 MG Oral TabletSCD4
197944methocarbamol 750 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
METHOCARBAMOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-610-602025-01-30C16284748780-11030e365-6f8f-111a-e063-dadaa90a10e2METHOCARBAMOL
61919-627-902025-01-30C16284748780-11030e365-6f8f-111a-e063-dadaa90a10e2METHOCARBAMOL
61919-903-902025-01-30C16284748780-11030e365-6f8f-111a-e063-dadaa90a10e2METHOCARBAMOL
61919-627-902024-01-30C16284748780-11030e365-6f8f-111a-e063-dadaa90a10e2METHOCARBAMOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-610-60Methocarbamol60 in 1 BOTTLETABLET, COATED604
61919-627-90METHOCARBAMOL90 in 1 BOTTLETABLET, FILM COATED904
61919-903-90METHOCARBAMOL90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-610METHOCARBAMOL TABLET, FILM COATED METHOCARBAMOL TABLET, COATED METHOCARBAMOL TABLET [DIRECTRX]4Legacy NDC, 1 package rows20190424_270b68a6-1469-190d-e054-00144ff8d46c.zip
61919-627METHOCARBAMOL TABLET, FILM COATED METHOCARBAMOL TABLET, COATED METHOCARBAMOL TABLET [DIRECTRX]4Legacy NDC, 1 package rows20190424_270b68a6-1469-190d-e054-00144ff8d46c.zip
61919-903METHOCARBAMOL TABLET, FILM COATED METHOCARBAMOL TABLET, COATED METHOCARBAMOL TABLET [DIRECTRX]4Legacy NDC, 1 package rows20190424_270b68a6-1469-190d-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-627-30EA - Each61919-627311662f6-485a-4dac-95d7-3df085a6348912016-09-02
61919-627-90EA - Each61919-627e3d1de1a-d8a6-46e0-a8ed-a8e655b1477812016-09-02
61919-610-30EA - Each61919-6104d7dcd54-9181-43b0-a540-df32fde72f9d12019-09-05
61919-610-40EA - Each61919-6100a034f36-4377-4466-808d-8b6c4e16254312019-09-05
61919-610-60EA - Each61919-610653ccadc-ba94-48da-b2f8-0f93a056c63a12019-05-02
61919-610-90EA - Each61919-610a1b60f03-73ce-4d6e-86be-65b86e682f8612019-09-05
61919-903-30EA - Each61919-903df58476d-dfc9-468f-982a-2d686fce96e412019-09-05
61919-903-60EA - Each61919-90360bc7e16-5d76-462e-aec4-8d7795c6add412019-09-05
61919-903-72EA - Each61919-90345ae4634-28a9-4b25-82e2-4438ca4b0d5312022-08-04
61919-903-90EA - Each61919-9030d575a9f-962b-4500-b10d-6f0e13079e1e12019-05-02
76439-135-10EA - Each76439-1359e5af9ba-e82f-44b8-86f9-582f3c7494d312014-02-04
76439-135-50EA - Each76439-1352bf0a265-7930-4a47-b84c-14fe5637df6c12014-02-04
70010-754-01EA - Each70010-754a93e091c-1727-4e82-b9fa-fceda19b340212018-08-13
70010-754-05EA - Each70010-7542371a0a4-be07-42fc-a17f-4211dcd83aaa12018-08-13
31722-534-01EA - Each31722-5341e316a97-b5be-4660-9bce-2534cec2f84512012-07-24
31722-534-05EA - Each31722-5342bdfd8a0-8c5c-4fb6-8289-604c56329e7912012-07-24

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-62761919-627-90
61919-61061919-610-60
61919-90361919-903-90
76439-135
70010-754
31722-534

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TRIACETINXHX3C3X673IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
METHOCARBAMOL125OD7737XACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
METHOCARBAMOL125OD7737XACTIB
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHOCARBAMOL125OD7737XACTIB
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
POVIDONE K90RDH86HJV5ZIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

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 · 3 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090200-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2009-11-06
A090200-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2009-11-06

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0684e616aacf4f…
2026-09-14 22:38:342026-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0684e616aacf4f…
2026-08-18 06:07:402026-07A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0674a2ff9319b5…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090200-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A090200-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A090200-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A090200-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090200-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090200-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090200-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090200-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090200-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090200-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090200-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090200-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090200-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090200-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090200-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090200-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090200-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090200-002AA174a2ff9319b5…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200958-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2011-10-21
A200958-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2011-10-21
A200958-003METHOCARBAMOLMETHOCARBAMOL1GMTABLET / ORALABRS2021-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A200958-001AA
A200958-002AA
A200958-003AB

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 4 · 121 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-2184e616aacf4f…
2026-09-14 22:38:342026-08A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-2184e616aacf4f…
2026-09-14 22:38:342026-08A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-0684e616aacf4f…
2026-08-18 06:07:402026-07A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-002METHOCARBAMOL750MGTABLET / ORALAA2011-10-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-003METHOCARBAMOL1GMTABLET / ORALABRS2021-12-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200958-001METHOCARBAMOL500MGTABLET / ORALAA2011-10-21301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 109 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A200958-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A200958-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A200958-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A200958-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A200958-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A200958-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200958-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200958-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200958-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200958-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200958-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200958-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200958-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200958-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200958-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200958-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200958-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200958-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200958-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200958-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200958-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200958-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200958-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200958-001AA1301d65b070ca…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209312-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAARS2018-05-07
A209312-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAARS2018-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209312-001AA
A209312-002AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0784e616aacf4f…
2026-09-14 22:38:342026-08A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0784e616aacf4f…
2026-08-18 06:07:402026-07A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209312-002METHOCARBAMOL750MGTABLET / ORALAA2018-05-0774a2ff9319b5…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209312-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A209312-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A209312-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A209312-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209312-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209312-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209312-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209312-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209312-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209312-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209312-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209312-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209312-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209312-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209312-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209312-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209312-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209312-002AA174a2ff9319b5…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOL TABLETSGranules Pharmaceuticals Inc.6f0d3966-962d-fa7c-e053-2a91aa0a8e3c2026-07-07Warnings, Adverse reactionsExact identifier
ndc (product): 70010-754
MethocarbamolMETHOCARBAMOLCamber Pharmaceuticals, Inc.43af0c41-9990-4902-9384-75de5ea082832021-04-06Warnings, Adverse reactionsExact identifier
ndc (product): 31722-534
87388b8c-daa4-3fbb-e053-2a91aa0a3e9b270b68a6-1469-190d-e054-00144ff8d46c2019-04-23Warnings, Adverse reactionsExact identifier
spl id: 87388b8c-daa4-3fbb-e053-2a91aa0a3e9b
spl set id: 270b68a6-1469-190d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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