Pain Relief Anti inflammatory

Product NDC
52904-486
11-digit product format
529040486
Labeler code
52904
Product ID
52904-486_5cfb8979-277a-418e-800e-11dd0c0ed783
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
Select Corporation
Application
ANDA091239
Marketing category
ANDA
Marketing start
2012-10-15
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct52904-486IInactivated by FDA2026-08-17
excluded packagepackage52904-48652904-486-02IInactivated by FDA2026-08-17

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 · 42 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 packagepackage52904-486-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-486-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-486-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-486-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-486-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-486-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-486-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-486-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-486-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-486-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52904-486-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52904-486-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52904-486-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52904-486-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52904-486-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage52904-486-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage52904-486-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage52904-486-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52904-486-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52904-486-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52904-486-029bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091239-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-02-01

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013f01610625f2…
2019-09-15 20:21 UTC2019-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01e64feba35796…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52904-486-022020-01-31C16284748780-19d75b9d0-bf41-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-486-02Pain Relief Anti inflammatory2 in 1 PACKETTABLET21

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-486PAIN RELIEF ANTI INFLAMMATORY (IBUPROFEN) TABLET [SELECT CORPORATION]1Legacy NDC, 1 package rows20121106_87178ec8-6777-4c6c-accb-6138ec4968d4.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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENGrocery Outlet, Inc.44660e1d-79c2-34ce-e063-6294a90ade3f2026-03-17WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENKroger Companybc173f1b-2e44-2c2e-e053-2a95a90a89c42025-09-24WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENTIME CAP LABORATORIES,INCf58d35f9-e44b-417b-98ce-0766b537cd2f2025-06-12WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENWALGREENS7653b33c-7489-10db-e053-2991aa0ab5082025-06-06WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
AeroTab IbuprofenIBUPROFEN TABLETAero Healthcareddd0f7fb-ae4b-c584-e053-2a95a90a09842025-02-26WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
VALUMEDS IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS LLCa6d4ceb0-2b79-496a-aa1e-27edd507ced02024-12-10WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENSAM'S WEST INC16595d75-6e74-0839-e063-6394a90abc132024-05-28WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENWALGREENS746f79aa-3036-1b9b-e053-2a91aa0a1db62024-03-18WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFEN CAIBUPROFENTARGET CORPORATION8e8684fa-095e-c6d6-e053-2a95a90a15b42024-01-03WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENTARGET CORPORATION8e86ae68-7687-79d6-e053-2995a90ac2742024-01-03WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb613c44-e125-0f40-e053-2995a90a7ca52023-10-02WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb60e636-41fe-49fb-e053-2a95a90a06162023-09-29WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ibuprofenIBUPROFENDOLGENCORP INC8f1358aa-495a-23da-e053-2995a90aa4302023-01-02WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENRITE AID CORPORATIONa7aa790a-6d6c-7929-e053-2995a90a1cf82022-01-04WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENMARKSANS PHARMA LIMITED3c8df1e5-61bc-4e70-b6b9-8973986ad5892021-12-21WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENRITE AID CORPORATIONa7abac4c-7695-cfe8-e053-2a95a90ac1cd2021-10-30WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN87178ec8-6777-4c6c-accb-6138ec4968d41
310965ibuprofen 200 MG Oral TabletSCD87178ec8-6777-4c6c-accb-6138ec4968d41
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY87178ec8-6777-4c6c-accb-6138ec4968d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52904-486-02529040486022 in 1 PACKETHistorical