Ibuprofen

Product NDC
49035-248
11-digit product format
490350248
Labeler code
49035
Product ID
49035-248_db1fa1a0-a22b-47ce-9346-02d5f406af49
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.)
Application
ANDA079174
Marketing category
ANDA
Marketing start
2013-12-30
Marketing end
2020-12-30
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct49035-248DDiscontinued by firm2026-10-05
excluded packagepackage49035-24849035-248-05DDiscontinued 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 packagepackage49035-248-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-248-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49035-248-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49035-248-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49035-248-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49035-248-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49035-248-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-248-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-248-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49035-248-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49035-248-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49035-248-05557ba5c1ecfa…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
A079174-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2010-12-10

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 22:38:342026-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1084e616aacf4f…
2026-08-18 06:07:402026-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

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 4 · 70 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.8c3ca03e-0ec2-c15c-e053-2995a90ad8bd2025-12-18WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY7e2ab4f1-2e87-4fbf-8882-e4d20aef142c2025-12-11WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY02e4418a-93ed-2212-e063-6294a90a6c8a2025-12-11WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY88b3f388-46d3-4e42-98fb-0351c76a15fc2025-12-11WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Lil Drug Store IbuprofenIBUPROFENLil Drug Store Products, Incc3be5923-9299-49b0-a455-e0c1c86985a82025-12-01WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
CAREALL IbuprofenIBUPROFENNew World Imports246cf64a-162d-47a4-910a-9fb0b9be3dd12025-12-01WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES , LLC.8f9f099a-ee59-0b9a-e053-2a95a90a2fe12025-11-18WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES , LLC.8f9f308f-0ca5-12fa-e053-2995a90a47fc2025-11-18WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Physicians Care IbuprofenIBUPROFEN 200MGAcme United Corporation490e551c-0e80-3d95-e054-00144ff8d46c2025-10-31WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENHEBacf86f62-1d55-4281-95b7-8b2b51eb7c892025-09-10WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENHEBc04ad0b4-5d8a-4861-9eaa-b2aaa7b196642025-09-10WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Green Guard Ibuprofen ReliefIBUPROFENUnifirst First Aid0798e401-8247-2fce-e054-00144ff8d46c2025-09-09WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Medique at Home IprinIBUPROFENUnifirst First Aid Corporationb5547f33-2a81-867d-e053-2995a90aa2d02025-09-09WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Medique IprinIBUPROFENUnifirst First Aid Corporation0607edb0-1b3a-2ccd-e054-00144ff8d46c2025-09-09WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Unishield IbuprofenIBUPROFENUnishieldb9e2e2ba-e2ad-eace-e053-2995a90aed352025-09-09WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Direct Safety IbuprofenIBUPROFENConney Safety Products, LLC07afce34-aaea-50a1-e054-00144ff88e882025-09-09WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Uline IbuprofenIBUPROFENUlined7342a15-9d49-74ed-e053-2a95a90a22cc2025-09-09WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
McKesson Ibuprofen 200 mgIBUPROFENMcKesson Medical-Surgicalca75b9fe-5bc8-ab90-e053-2995a90a52fb2025-09-09WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Ibuprofen ThompsonIBUPROFENThompson Safetyccfbc048-f666-3188-e053-2995a90ae08f2025-09-08WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0e95aab9-3a7c-49c3-b8df-f66d6f31aee02025-07-31WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174