welby ibuprofen

Product NDC
64024-002
11-digit product format
640240002
Labeler code
64024
Product ID
64024-002_0f476f6d-fb73-49c2-92f7-ff6031eff8c8
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aldi, Inc
Application
ANDA072096
Marketing category
ANDA
Marketing start
2016-01-07
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
2027-12-31
Current FDA listing
Yes

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 packagepackage64024-00264024-002-90DDiscontinued 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 · 16 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 packagepackage64024-002-78d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64024-002-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64024-002-78f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64024-002-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64024-002-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64024-002-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64024-002-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64024-002-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64024-002-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64024-002-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64024-002-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64024-002-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64024-002-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64024-002-90557ba5c1ecfa…9c80585c8c6e…

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

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
A072096-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-12-08

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0884e616aacf4f…
2026-08-18 06:07:402026-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
welby ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64024-002WELBY IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [ALDI, INC]4Current NDC, Legacy NDC20240510_abe3ea47-a99b-4115-add5-12d58ae92e51.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 3 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENH E Ba340ed68-debb-4c1e-97eb-82f6e9e3854f2024-12-02WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
365 whole foods market ibuprofenIBUPROFENWhole Foods Market, INC.e914472b-c785-4c73-b37c-4d459166cf412024-11-26WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
dg health ibuprofenIBUPROFENDolgencorp, LLCfd27d4e1-8edf-4bc3-a593-6be5c3345ed02024-11-13WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENA-S Medication Solutions9ac095d2-ba19-4da1-acc9-85f7b4ae304d2024-11-04WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equate ibuprofenIBUPROFENWal-Mart Stores Inc307b0257-d636-416b-828a-f901782e9b102024-09-13WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENBryant Ranch Prepack22cb2ccc-ba4d-4069-8334-f886f0e3e8022024-07-12WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
IBUPROFEN 100IBUPROFENJHK Inc dba American Safety & First Aid218f6df9-dd04-45b6-8a45-3276691abee22024-04-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENH E Be00acbc0-352e-4ba1-8433-18a3079f67432024-04-12WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
pain reliefIBUPROFENMeijer, Inc.1f965703-3262-4dd1-b4f8-6341786553b12024-02-07WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENA-S Medication Solutions57af05fc-30b9-4487-9a37-fb35dac4acf72024-01-29WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
dg health ibuprofenIBUPROFENDolgencorp Inc98492b9f-8f48-42dd-b026-c37dcdc5f8882024-01-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
foster and thrive ibuprofenIBUPROFENStrategic Sourcing Services LLC68d67a25-e669-47c7-8410-9f304b914ff12023-10-31WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENMeijer Distribution Ince578de96-747e-4104-8db6-e6521e6052a52023-10-09WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Signature Care IbuprofenIBUPROFENSafeway93edca03-fdf1-453f-8efe-5f0b8eef41e42023-09-28WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
betr remedies ibuprofenIBUPROFENLive Betr LLC0a50820f-1dfa-45b5-824f-2c28822fc6c62023-07-26WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Good Sense IbuprofenIBUPROFENL. Perrigo Companyf9af5970-18ca-46d5-8d6c-c0fec22a66d52023-07-21WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENL. Perrigo Company9164f7e8-81a0-4b71-a2b3-111b2a7541bb2023-07-12WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
basic care ibuprofenIBUPROFENAmazon.com Services LLC3329f487-675d-440c-b7c5-d17a2b0242752023-05-31WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENProficient Rx LP4ee828df-873d-4379-9a17-a805d97dfe042023-04-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
betr pain reliefIBUPROFENLive Betr LLC1b709dce-5c71-45e6-b516-d510a0a8c25d2022-08-24WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64024-002-78640240002781 BOTTLE in 1 CARTON (64024-002-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-01-070000-00-00NoNoCurrent