Up and Up Ibuprofen

Product NDC
11673-461
11-digit product format
116730461
Labeler code
11673
Product ID
11673-461_d88c3afb-6352-4da4-bc65-af9f9b9b3367
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Target Corporation
Application
ANDA076359
Marketing category
ANDA
Marketing start
2013-03-04
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11673-461DDiscontinued by firm2026-10-05
excluded packagepackage11673-46111673-461-62DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11673-461-62d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11673-461-62f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11673-461-622ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11673-461-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11673-461-62cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11673-461-62cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11673-461-62302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11673-461-62ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11673-461-620efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11673-461-62ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11673-461-62367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11673-461-62557ba5c1ecfa…9c80585c8c6e…

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
A076359-001IBUPROFENIBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16
A076359-002IBUPROFENIBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16

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 22:38:342026-08A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1684e616aacf4f…
2026-09-14 22:38:342026-08A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1684e616aacf4f…
2026-08-18 06:07:402026-07A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1674a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMUP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
IBUPROFENACTIVE MOIETYWK2XYI10QMUP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9UP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1UP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZUP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48UP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOUP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30UP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AUP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4UP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JUP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
SOYBEAN OILINACTIVE INGREDIENT241ATL177AUP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LUP AND UP IBUPROFEN JUNIOR (IBUPROFEN) TABLET, CHEWABLE [TARGET CORPORATION]2

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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens ibuprofenIBUPROFENKroger Company1b78bdeb-efb2-4f5a-af3f-d67d820908472025-08-22WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
equate ibuprofenIBUPROFENWal-Mart Stores Incabef43bc-ee9b-4a9c-9cf9-36c3232139092025-08-21WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
childrens ibuprofenIBUPROFENMeijer Distribution Incd42f9f7c-fe4f-45eb-a455-bffb41295fdc2025-08-20WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
equaline childrens ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI3a166a74-cdc4-4620-b796-750464e15dc02025-08-20WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
CHILDRENS IBUPROFENIBUPROFENMeijer, Inc.eed4f13d-4bee-4ccc-a651-a6f86d6d1f7b2025-08-04WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
Childrens IbuprofenIBUPROFENPublix Super Markets Inc54ae0273-4d8d-4c3b-85ff-675ba96f00de2025-07-22WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
topcare childrens ibuprofenIBUPROFENTopco Associates LLCa88020c0-7982-4307-9836-74de66ea47a52025-07-17WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
childrens ibuprofenIBUPROFENMeijer Distribution Inccfe27d2a-b602-4b3e-bdcb-14fed4a236ca2025-07-17WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
childrens ibuprofenIBUPROFENCVS Pharmacy884d51d8-4774-4dde-b854-32abfb4b712d2025-05-20WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
Good Sense Childrens IbuprofenIBUPROFENL. Perrigo Companya8fc1b0c-dd69-4567-8eea-de4d9b0c77402025-05-07WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
foster and thrive childrens ibuprofen ibIBUPROFENStrategic Sourcing Services LLC37adf659-9a92-428b-ac99-5718f242a4e92025-05-07WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
signature care childrens ibuprofenIBUPROFENSafewayc30fbb8f-a293-4f6e-9495-11402548fe2d2022-11-15WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
rexall ibuprofenIBUPROFENDolgencorp, LLC869185d5-9f34-4d38-9551-dd0b4fc8557d2021-09-09WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLCb17b0aac-55d2-4917-a722-b8587ad643bc2021-08-13WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLC18e5eed7-d3be-4559-93ca-b40ee26c7bd82020-09-09WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
Basic Care Childrens IbuprofenIBUPROFENAmazon.com Services LLCd53cb3f1-6689-40dd-bdea-fad3a841d4822020-09-03WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
childrens ibuprofenIBUPROFENRite Aid Corporationaf68a4bf-bc49-40c7-812d-035eff474ed92020-04-03WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-461-62116730461621 BOTTLE in 1 CARTON (11673-461-62) > 24 TABLET, CHEWABLE in 1 BOTTLE1 bottle2013-03-040000-00-00NoNoCurrent