Motrin IB

Product NDC
67751-165
Requested package NDC
67751-165-01
11-digit product format
677510165
Labeler code
67751
Product ID
67751-165_6140a82d-8357-fe50-e053-2991aa0a2d7d
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
NDA019012
Marketing category
NDA
Marketing start
2016-09-22
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67751-16567751-165-01DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019012-001NUPRINIBUPROFEN200MGTABLET / ORAL1984-05-18
N019012-002NUPRINIBUPROFEN200MGTABLET / ORAL1987-07-29
N019012-003MOTRIN IBIBUPROFEN200MGTABLET / ORALRLD1990-12-17
N019012-004MOTRIN MIGRAINE PAINIBUPROFEN200MGTABLET / ORAL2000-02-25

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019012-001NUPRIN200MGTABLET / ORAL1984-05-1884e616aacf4f…
2026-09-14 22:38:342026-08N019012-002NUPRIN200MGTABLET / ORAL1987-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-2584e616aacf4f…
2026-08-18 06:07:402026-07N019012-001NUPRIN200MGTABLET / ORAL1984-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07N019012-002NUPRIN200MGTABLET / ORAL1987-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019012-001NUPRIN200MGTABLET / ORAL1984-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019012-002NUPRIN200MGTABLET / ORAL1987-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019012-001NUPRIN200MGTABLET / ORAL1984-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019012-002NUPRIN200MGTABLET / ORAL1987-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N019012-001NUPRIN200MGTABLET / ORAL1984-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019012-002NUPRIN200MGTABLET / ORAL1987-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019012-001NUPRIN200MGTABLET / ORAL1984-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019012-002NUPRIN200MGTABLET / ORAL1987-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019012-001NUPRIN200MGTABLET / ORAL1984-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019012-002NUPRIN200MGTABLET / ORAL1987-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019012-001NUPRIN200MGTABLET / ORAL1984-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019012-002NUPRIN200MGTABLET / ORAL1987-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019012-001NUPRIN200MGTABLET / ORAL1984-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019012-002NUPRIN200MGTABLET / ORAL1987-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019012-001NUPRIN200MGTABLET / ORAL1984-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019012-002NUPRIN200MGTABLET / ORAL1987-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-255bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
67751-165-012023-03-16Motrin IB
67751-165-022023-03-16Motrin IB
67751-165-012023-01-30Motrin IB
67751-165-022023-01-30Motrin IB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Motrin IBIBUPROFENSavings Distributors LLC56846774-8413-c306-e063-6394a90a2be82026-01-01WarningsExact identifier
application applno (NDA): 019012
application number: NDA019012
Motrin IBIBUPROFENNavajo Manufacturing Company Inc.f70c1b68-61c8-b333-e053-6294a90aadaa2023-03-16WarningsExact identifier
application applno (NDA): 019012
application number: NDA019012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-165-01677510165011 POUCH in 1 CARTON (67751-165-01) > 2 TABLET, FILM COATED in 1 POUCH1 pouch2016-09-220000-00-00NoNoCurrent