DG Health Ibuprofen

Product NDC
55910-074
11-digit product format
559100074
Labeler code
55910
Product ID
55910-074_496e3d2d-84ba-44e3-85e0-be8898766b83
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dolgencorp, LLC
Application
ANDA077349
Marketing category
ANDA
Marketing start
2010-02-01
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55910-074DDiscontinued by firm2026-08-03
excluded packagepackage55910-07455910-074-71DDiscontinued by firm2026-08-03
excluded packagepackage55910-07455910-074-78DDiscontinued by firm2026-08-03
excluded packagepackage55910-07455910-074-85DDiscontinued by firm2026-08-03

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 packagepackage55910-074-78d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55910-074-85d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55910-074-71d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55910-074-78f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55910-074-85f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55910-074-71f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55910-074-782ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55910-074-852ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55910-074-712ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55910-074-78a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55910-074-85a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55910-074-71a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55910-074-78cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55910-074-85cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55910-074-71cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55910-074-78cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55910-074-85cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55910-074-71cdf11ea48f46…ba0047e9e063…

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…

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 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-074-71559100074711 BOTTLE in 1 CARTON (55910-074-71) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-03-190000-00-00NoNoCurrent
55910-074-78559100074781 BOTTLE in 1 CARTON (55910-074-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2010-02-010000-00-00NoNoCurrent
55910-074-8555910007485250 TABLET, FILM COATED in 1 BOTTLE (55910-074-85) 2012-10-020000-00-00NoNoCurrent