Ibuprofen

Product NDC
56062-131
11-digit product format
560620131
Labeler code
56062
Product ID
56062-131_fe9a64cc-8824-4984-acf5-7973561fb243
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Publix Super Markets Inc
Application
ANDA203599
Marketing category
ANDA
Marketing start
2017-08-02
Marketing end
0000-00-00
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
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 productproduct56062-131DDiscontinued by firm2026-08-10
excluded packagepackage56062-13156062-131-06DDiscontinued by firm2026-08-10
excluded packagepackage56062-13156062-131-27DDiscontinued by firm2026-08-10
excluded packagepackage56062-13156062-131-58DDiscontinued by firm2026-08-10

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 packagepackage56062-131-58d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage56062-131-27d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage56062-131-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage56062-131-58f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage56062-131-27f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage56062-131-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage56062-131-582ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage56062-131-272ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage56062-131-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage56062-131-58a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage56062-131-27a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage56062-131-06a1b67e2a42f9…c4cf2c586c0d…

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
A203599-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07

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 UTC2026-02A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-073f01610625f2…
2019-09-15 20:21 UTC2019-09A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07cb3db0bc1861…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health ibuprofenIBUPROFENDolgencorp Inc74f46147-b4c2-4bb3-bd0a-220c0a5403a62025-04-01WarningsExact identifier
application applno (ANDA): 203599
application number: ANDA203599
good sense ibuprofenIBUPROFENL. Perrigo Company0cb4b0ef-5cdd-4c79-8718-4fb157a2c9482025-03-29WarningsExact identifier
application applno (ANDA): 203599
application number: ANDA203599
good sense ibuprofenIBUPROFENL. Perrigo Company3b78c004-e4fe-449c-86e9-52e8ccf127852025-03-25WarningsExact identifier
application applno (ANDA): 203599
application number: ANDA203599
basic care ibuprofenIBUPROFENAmazon.com Services LLC25bc5cc2-9b6a-47e4-8b3d-2bb370907b612025-03-20WarningsExact identifier
application applno (ANDA): 203599
application number: ANDA203599
basic care ibuprofenIBUPROFENAmazon.com Services LLCcd15159a-9ed5-453a-9ad4-0c9688204c822025-03-19WarningsExact identifier
application applno (ANDA): 203599
application number: ANDA203599

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-131-06560620131061 BOTTLE in 1 CARTON (56062-131-06) > 160 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2018-01-170000-00-00NoNoCurrent
56062-131-27560620131271 BOTTLE in 1 CARTON (56062-131-27) > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2017-08-070000-00-00NoNoCurrent
56062-131-58560620131581 BOTTLE in 1 CARTON (56062-131-58) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2017-08-020000-00-00NoNoCurrent