Motrin IB

Product NDC
67414-240
11-digit product format
674140240
Labeler code
67414
Product ID
67414-240_ddd2849e-23ea-dd00-e053-2995a90a252f
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jones Healthcare Group - Packaging Services, Inc
Application
ANDA077349
Marketing category
ANDA
Marketing start
2016-07-01
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077349-001IBUPROFENIBUPROFEN200MGTABLET / ORALRS2005-06-21

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Motrin IB
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
201126Internal RxNorm lookup
310965Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6419cc78-27d4-7713-e053-2a91aa0a5a10Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67414-240-00Motrin IB2500 in 1 BOXTABLET, FILM COATED25005
67414-240-00Motrin IB2 in 1 POUCHTABLET, FILM COATED25
67414-240-09Motrin IB2 in 1 POUCHTABLET, FILM COATED25
67414-240-09Motrin IB50 in 1 CARTONTABLET, FILM COATED505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67414-240MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JONES HEALTHCARE GROUP - PACKAGING SERVICES, INC]5Current NDC, Legacy NDC, 4 package rows20220430_6419cc78-27d4-7713-e053-2a91aa0a5a10.zip

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENH E B21567c0f-abba-4a40-a0b9-5ce49b3d96482026-07-28WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
Motrin IBIBUPROFENSelect Consumer Group LLC52c650cf-3085-7b2c-e063-6394a90a797f2026-05-27WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
CareOne IbuprofenIBUPROFENAmerican Sales Company03cdff8a-8890-440d-82b5-54ce809f88cc2026-02-03WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
Motrin IB, TRAVEL BASIXIBUPROFENLil' Drug Store Products, Inc.c2b99756-3e03-4d9f-9ce6-7db879afe3a12025-12-10WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
IbuprofenIBUPROFENCVS Pharmacy93f8101c-1cf7-4cb0-9c00-c57c9f9023c82025-10-26WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
Motrin IBIBUPROFENKenvue Brands LLCd21129f8-4d96-4e36-bc39-a534306dd77e2025-10-03WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
leader ibuprofenIBUPROFENCardinal Health 110, LLC. dba Leader96da60f7-06a9-438a-ae59-8609fdd1587d2025-09-25WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
ibuprofenIBUPROFENPublix Super Markets Incc5cd3843-8d72-4850-bebe-4ac54e4f43fa2025-08-21WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
ibuprofen 200IBUPROFENWalgreen Company49a3d51d-55d1-4b80-ab7b-35c27a937cb92025-07-02WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
Topcare ibuprofenIBUPROFENTopco Associates LLC479a0c97-dbd9-47ad-9910-9dd4edf5136f2025-07-02WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
Motrin IBIBUPROFENMorning Star OTCe69f00c4-b8ec-4a83-9eea-8cb2835ad7762025-06-19WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
MOTRIN IBIBUPROFENJC World Bell Wholesale Co., Inc.4e7516e1-184a-45e9-b908-228121f163f62024-12-27WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
kirkland signature ibuprofen ibIBUPROFENCostco Wholesale Company2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c2024-10-14WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
dg health ibuprofenIBUPROFENDolgencorp Incb514b589-d965-4a21-91b3-fab4019e9d962024-04-12WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
basic care ibuprofenIBUPROFENAmazon.com Services LLC5ada3dbe-af87-49db-a6b0-0a1c02111cbf2024-03-11WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
signature care ibuprofenIBUPROFENSafeway95904b21-752d-48b4-a882-8d81d2384e1f2024-02-01WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
Good Neighbor Pharmacy ibuprofenIBUPROFENAmerisource Bergen74b227c9-8341-44df-a763-cfeb371c0d282023-08-17WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
Good Sense ibuprofenIBUPROFENL. Perrigo Companyaebae4b3-18c8-4ecf-b578-1fe7cc50076b2023-06-28WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
Equate IbuprofenIBUPROFENWal-Mart Stores Inc153bc4ac-427d-426a-9bb8-665487e4b1692023-04-27WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
Motrin IBIBUPROFENJones Healthcare Group - Packaging Services, Inc6419cc78-27d4-7713-e053-2a91aa0a5a102022-04-29WarningsExact identifier
application applno (ANDA): 077349
application number: ANDA077349
ndc (product): 67414-240

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN6419cc78-27d4-7713-e053-2a91aa0a5a105
201126Motrin IB 200 MG Oral TabletPSN6419cc78-27d4-7713-e053-2a91aa0a5a105
201126ibuprofen 200 MG Oral Tablet [Motrin]SBD6419cc78-27d4-7713-e053-2a91aa0a5a105
310965ibuprofen 200 MG Oral TabletSCD6419cc78-27d4-7713-e053-2a91aa0a5a105
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY6419cc78-27d4-7713-e053-2a91aa0a5a105
201126Motrin 200 MG Oral TabletSY6419cc78-27d4-7713-e053-2a91aa0a5a105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67414-240-00674140240002500 POUCH in 1 BOX (67414-240-00) / 2 TABLET, FILM COATED in 1 POUCH2500 pouch2018-01-250000-00-00NoNoCurrent
67414-240-096741402400950 POUCH in 1 CARTON (67414-240-09) / 2 TABLET, FILM COATED in 1 POUCH50 pouch2018-01-250000-00-00NoNoCurrent