Sound Body Ibuprofen

Product NDC
50594-020
Requested package NDC
50594-020-76
11-digit product format
505940020
Labeler code
50594
Product ID
50594-020_988e7167-144e-4986-9bdc-b98ab3aaec50
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Big Lots Stores, Inc.
Application
ANDA072096
Marketing category
ANDA
Marketing start
2016-09-19
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50594-02050594-020-76DDiscontinued by firm2026-08-03

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
A072096-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-12-08

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 UTC2026-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08cb3db0bc1861…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50594-020SOUND BODY IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [BIG LOTS STORES, INC.]5Legacy NDC20231215_f32f7e89-7d54-4001-92cb-b062c059fd9a.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 4 · 67 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Ince7175dc9-db39-4452-a419-85af179de4222026-07-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENBryant Ranch Prepackd6460cc3-c207-44e0-bf78-ad6fef055ed52026-07-09WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENUnit Dose Solutions, Inc.551535ce-eab0-bb13-e063-6294a90a20702026-06-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Berkley and Jensen IbuprofenIBUPROFENBJWCcda57e42-6106-46ee-82d1-479a692ee5bb2026-05-21WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen085dcc1a-e4b0-4d08-9476-72275382d1a12026-05-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.f1a03b1f-2d87-43cc-b256-bd296ccd09f22026-05-13WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENKroger Company6307485a-8be6-40ee-899b-00eb3ee8ce612026-05-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
CounterAct IBIBUPROFENMelaleuca, Inc7fafc13e-3fee-ace3-e053-2a91aa0ac2ea2026-03-17Boxed warning, WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderd673266c-3d2b-479f-9b53-cdd1b86513932026-02-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Inc4c24c884-55f7-40b4-8d6f-db6144d5ebcb2026-02-05WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Inc5233c409-3743-4312-9f75-14ded6755b5c2026-02-02WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equate ibuprofenIBUPROFENWal-Mart Stores Incb29034a6-657b-426f-a41a-5e64c4bc759d2026-01-20WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENCVS Pharmacyace493e6-91bc-41aa-8e5c-5bc14981de912026-01-06WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENNorthwind Health Company, LLCda6c2802-5d15-dbcb-e053-2a95a90a25612026-01-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENL. Perrigo Company70d0a429-27c1-43a5-b2ea-a9919e0910f82025-12-22WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENNuCare Pharmaceuticals, Inc.463ea713-6b27-b00b-e063-6394a90a86462025-12-18WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.96bff700-bca3-4b94-b8a2-379102721db82025-12-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.c447fc6b-e9ef-447a-9609-5f893e18dfa72025-11-17WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
GOODNOW PAIN RELIEFIBUPROFENGobrands, Inc0759085d-6ac3-446b-ac2c-8dc30e32e1d12025-11-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50594-020-76505940020761 BOTTLE in 1 CARTON (50594-020-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-09-190000-00-00NoNoCurrent