ibuprofen

Product NDC
30142-057
11-digit product format
301420057
Labeler code
30142
Product ID
30142-057_37ee9426-7db6-4c50-bb5c-59654ebc0b81
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kroger Company
Application
ANDA075217
Marketing category
ANDA
Marketing start
2002-11-20
Marketing end
2021-01-31
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
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 productproduct30142-057DDiscontinued by firm2026-08-03
excluded packagepackage30142-05730142-057-05DDiscontinued 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 packagepackage30142-057-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage30142-057-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage30142-057-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage30142-057-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage30142-057-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage30142-057-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage30142-057-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage30142-057-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage30142-057-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage30142-057-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage30142-057-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage30142-057-05557ba5c1ecfa…9c80585c8c6e…

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
A075217-001IBUPROFENIBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16

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 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 UTC2026-02A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30142-057-05ML - Milliliter30142-057d6ad8b1a-7935-4571-b913-e9dcc3f4b02a12014-01-04

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 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENRite Aid Corporation99a76de3-166a-4902-b400-b262a4fa0ae82026-05-27WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Good Sense Infants IbuprofenIBUPROFENL. Perrigo Company3d2fa7ad-1574-4c79-959d-3ee284468a992026-05-11WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
ibuprofen infantsIBUPROFENH E Be353bc69-c03e-4bae-a357-f7f3fab916952026-05-07WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
infants dye free ibuprofenIBUPROFENKroger Company6dc009c8-5b44-4d53-b053-eaed2223d9752026-05-05WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Good Sense ibuprofen infantsIBUPROFENL. Perrigo Companyc79e65e7-149b-450f-b083-99e16ff717292026-04-14WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
care one ibuprofenIBUPROFENAmerican Sales Company15f63d40-276c-4c02-9f8c-0354e47799162026-04-09WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
ibuprofenIBUPROFENCVS Pharmacye28d0916-8165-431c-a19c-ef7d4bb6b8e62026-02-26WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
ibuprofen infantsIBUPROFENHyVee Ince8fcaf17-234a-4d64-b621-9ca505884b0a2026-01-12WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Foster and Thrive IbuprofenIBUPROFENStrategic Sourcing Services LLCbcfa45ac-63d6-49a7-aa1c-b9f1d6c571f32025-10-22WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
ibuprofenIBUPROFENMeijer Distribution Ince28e64dc-5f4e-4260-953a-3de38a5eaa762025-09-15WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
INFANTS IBUPROFENIBUPROFENSafeway6fed7c65-69a3-4899-a85d-23ea95f571a42025-07-21WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
profen ib infantsIBUPROFENPublix Super Markets Inc84aea3fc-4f3b-4a76-a3a6-94ed6549dbea2025-07-17WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Dg Health IbuprofenIBUPROFENDolgencorp, LLC9022e393-084e-499b-ac84-f35360d795922025-07-17WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
dg health ibuprofenIBUPROFENDolgencorp, LLCd6dcbdee-7c0d-4b5c-b0c1-1e8f357f7f592025-05-15WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Equaline IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIc611afc0-5cde-4f01-908a-de52cb61ab022025-05-08WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
ibuprofenIBUPROFENMajor Pharmaceuticalsb4962985-47e6-4389-874f-76742b086e2f2025-05-03WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Topcare Infants IbuprofenIBUPROFENTopco Associates LLC00d33273-e8c7-4d40-8e6f-a980f746fff22025-05-03WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
profen ibIBUPROFENPublix Super Markets Incbee4b754-c476-4d0e-a1b4-4db8861af84a2025-05-01WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
parents choice infants ibuprofenIBUPROFENWal-Mart Stores Inca826d6cc-f582-4508-897d-0d637de0666c2025-04-07WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
up and up dye free infants concentrated ibuprofenIBUPROFENTarget Corporation6cfdcd94-95cb-4447-a14b-cdb49a1e31142025-04-07WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217