FDA.reportPublic FDA data

Motrin IB

Product NDC
50580-230
11-digit product format
505800230
Labeler code
50580
Product ID
50580-230_4003a46c-d99c-72f4-e063-6394a90ab2db
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
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
d21129f8-4d96-4e36-bc39-a534306dd77eAvailable 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50580-230-01Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-01Motrin IB50 in 1 BOTTLETABLET, FILM COATED5015
50580-230-02Motrin IB60 in 1 BOTTLETABLET, FILM COATED6015
50580-230-02Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-03Motrin IB100 in 1 BOTTLETABLET, FILM COATED10015
50580-230-03Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-04Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-04Motrin IB225 in 1 BOTTLETABLET, FILM COATED22515
50580-230-05Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-05Motrin IB300 in 1 BOTTLETABLET, FILM COATED30015
50580-230-06Motrin IB500 in 1 BOTTLETABLET, FILM COATED50015
50580-230-06Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-07Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-07Motrin IB24 in 1 BOTTLETABLET, FILM COATED2415
50580-230-08Motrin IB2 in 1 POUCHTABLET, FILM COATED215
50580-230-09Motrin IB2 in 1 POUCHTABLET, FILM COATED215
50580-230-09Motrin IB50 in 1 CARTONTABLET, FILM COATED5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-230-01EA - Each50580-230cc8f08de-0241-475b-a545-b0a755cb1af312018-04-19
50580-230-02EA - Each50580-230b0995e76-9209-4ee6-a3df-52dac753035112017-03-06
50580-230-03EA - Each50580-2309b1cf925-49e6-4fc4-8bc0-5214192c4f8312018-05-09
50580-230-04EA - Each50580-2307762e942-27c6-4845-ad02-dd99aa0860c012024-04-05
50580-230-06EA - Each50580-23087541607-8b7c-4ea4-bab2-4e4d9200867012016-12-07
50580-230-07EA - Each50580-230ce62c3eb-301b-4537-9973-a909356d679012023-12-05
50580-230-09EA - Each50580-2302ceccfbe-9a6a-44b6-a475-80dde15586a512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-230MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [KENVUE BRANDS LLC]14Current NDC, Legacy NDC, 17 package rows20241109_d21129f8-4d96-4e36-bc39-a534306dd77e.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
ndc (product): 50580-230
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNd21129f8-4d96-4e36-bc39-a534306dd77e15
201126Motrin IB 200 MG Oral TabletPSNd21129f8-4d96-4e36-bc39-a534306dd77e15
201126ibuprofen 200 MG Oral Tablet [Motrin]SBDd21129f8-4d96-4e36-bc39-a534306dd77e15
310965ibuprofen 200 MG Oral TabletSCDd21129f8-4d96-4e36-bc39-a534306dd77e15
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYd21129f8-4d96-4e36-bc39-a534306dd77e15
201126Motrin 200 MG Oral TabletSYd21129f8-4d96-4e36-bc39-a534306dd77e15
310965ibuprofen 200 MG Oral TabletPSN4e7516e1-184a-45e9-b908-228121f163f67
201126Motrin IB 200 MG Oral TabletPSN4e7516e1-184a-45e9-b908-228121f163f67
201126ibuprofen 200 MG Oral Tablet [Motrin]SBD4e7516e1-184a-45e9-b908-228121f163f67
310965ibuprofen 200 MG Oral TabletSCD4e7516e1-184a-45e9-b908-228121f163f67
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY4e7516e1-184a-45e9-b908-228121f163f67
201126Motrin 200 MG Oral TabletSY4e7516e1-184a-45e9-b908-228121f163f67
310965ibuprofen 200 MG Oral TabletPSNafa87bb5-7fcb-4ccd-acac-f7931242181f4
201126Motrin IB 200 MG Oral TabletPSNafa87bb5-7fcb-4ccd-acac-f7931242181f4
201126ibuprofen 200 MG Oral Tablet [Motrin]SBDafa87bb5-7fcb-4ccd-acac-f7931242181f4
310965ibuprofen 200 MG Oral TabletSCDafa87bb5-7fcb-4ccd-acac-f7931242181f4
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYafa87bb5-7fcb-4ccd-acac-f7931242181f4
201126Motrin 200 MG Oral TabletSYafa87bb5-7fcb-4ccd-acac-f7931242181f4
310965ibuprofen 200 MG Oral TabletPSNf70c1b68-61c8-b333-e053-6294a90aadaa1
310965ibuprofen 200 MG Oral TabletPSNe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
310965ibuprofen 200 MG Oral TabletPSN164689bf-cae3-4498-b076-d688ed24b5071
201126Motrin IB 200 MG Oral TabletPSN164689bf-cae3-4498-b076-d688ed24b5071
201126Motrin IB 200 MG Oral TabletPSNe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
201126Motrin IB 200 MG Oral TabletPSNf70c1b68-61c8-b333-e053-6294a90aadaa1
201126ibuprofen 200 MG Oral Tablet [Motrin]SBD164689bf-cae3-4498-b076-d688ed24b5071
201126ibuprofen 200 MG Oral Tablet [Motrin]SBDe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
201126ibuprofen 200 MG Oral Tablet [Motrin]SBDf70c1b68-61c8-b333-e053-6294a90aadaa1
310965ibuprofen 200 MG Oral TabletSCDe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
310965ibuprofen 200 MG Oral TabletSCDf70c1b68-61c8-b333-e053-6294a90aadaa1
310965ibuprofen 200 MG Oral TabletSCD164689bf-cae3-4498-b076-d688ed24b5071
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY164689bf-cae3-4498-b076-d688ed24b5071
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYf70c1b68-61c8-b333-e053-6294a90aadaa1
201126Motrin 200 MG Oral TabletSY164689bf-cae3-4498-b076-d688ed24b5071
201126Motrin 200 MG Oral TabletSYe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
201126Motrin 200 MG Oral TabletSYf70c1b68-61c8-b333-e053-6294a90aadaa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-230-01505800230011 BOTTLE in 1 CARTON (50580-230-01) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-02505800230021 BOTTLE in 1 CARTON (50580-230-02) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-03505800230031 BOTTLE in 1 CARTON (50580-230-03) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-04505800230041 BOTTLE in 1 CARTON (50580-230-04) / 225 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-05505800230051 BOTTLE in 1 CARTON (50580-230-05) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-06505800230061 BOTTLE in 1 CARTON (50580-230-06) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-07505800230071 BOTTLE in 1 CARTON (50580-230-07) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-07-170000-00-00NoNoCurrent
50580-230-08505800230082 TABLET, FILM COATED in 1 POUCH (50580-230-08) 2017-06-300000-00-00NoNoCurrent
50580-230-095058002300950 POUCH in 1 CARTON (50580-230-09) / 2 TABLET, FILM COATED in 1 POUCH50 pouch2017-04-240000-00-00NoNoCurrent