Basic Care ibuprofen

Product NDC
0113-0788
11-digit product format
001130788
Labeler code
0113
Product ID
0113-0788_295ed76a-ed7b-4a41-9009-479e25448cd1
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA076359
Marketing category
ANDA
Marketing start
2017-12-19
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0113-0788DDiscontinued by firm2026-08-11
excluded packagepackage0113-07880113-0788-62DDiscontinued by firm2026-08-11

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 packagepackage0113-0788-62d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0113-0788-62f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0113-0788-622ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0113-0788-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0113-0788-62cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0113-0788-62cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0113-0788-62302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0113-0788-62ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0113-0788-620efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0113-0788-62ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0113-0788-62367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0113-0788-62557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076359-001IBUPROFENIBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16
A076359-002IBUPROFENIBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16782e0a99824c…

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 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens ibuprofenIBUPROFENCVS Pharmacy6d047655-2b29-4f74-ac6e-93b02c25870c2026-06-01WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
Childrens IbuprofenIBUPROFENRite Aid Corporation5883ebd4-8cf7-45f1-8c66-e87416835fcc2026-05-27WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
good sense childrens ibuprofenIBUPROFENL. Perrigo Company19253175-4185-468d-9d3d-9b53be764e182026-04-07WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
childrens ibuprofenIBUPROFENCVS Pharmacy215e2275-2968-419c-9a89-8dbb3b4f4d2e2026-02-27WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
ibuprofenIBUPROFENHyVee Inc2fd51545-1d1f-4b2e-a084-d28ba223e7202026-01-13WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
GOOD SENSE CHILDRENS IBUPROFENIBUPROFENL. Perrigo Companycd06ffc5-4921-4b2d-88ea-939fa4daf59c2026-01-09WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
childrens ibuprofenIBUPROFENKroger Company96c955b1-3139-4b12-b584-83804bc1ca6b2025-11-03WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
Up and Up Childrens IbuprofenIBUPROFENTarget Corporation17b3ca97-1bd6-4e76-a47f-2e35ef36b7072025-10-28WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
childrens ibuprofen 100IBUPROFENWalgreen Company7b798146-393f-422c-87f0-0bf800df0c712025-10-28WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
careone childrens ibuprofenIBUPROFENAmerican Sales Companybca90b40-7973-4f22-8647-44cce5a6036e2025-10-28WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
childrens ibuprofen 100IBUPROFENWalgreen Company9b748f51-1d09-46ca-9dba-fec226c027e02025-10-26WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
Up and Up Childrens IbuprofenIBUPROFENTarget Corporationeead7d57-dfd3-4007-a620-74afebc3d3652025-10-26WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
childrens ibuprofenIBUPROFENSafeway6dbf5acc-46a1-4d5b-a9a6-9b77f106d7112025-10-14WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
Childrens MotrinIBUPROFENKenvue Brands LLC63ec7636-bf2a-4d52-ab88-fb93d41661ec2025-10-08WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
Childrens MotrinIBUPROFENKenvue Brands LLC15b0b56d-6188-4937-b541-902022e35b242025-10-07WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
careone childrens ibuprofenIBUPROFENAmerican Sales Companybf88f91c-70ed-42be-b79c-ec60d4f0acda2025-08-30WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader5975c324-2906-4e71-9b88-2e772d9fbfde2025-08-28WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
Good Neighbor Pharmacy Childrens IbuprofenIBUPROFENAmerisource Bergenf0a7070b-8acf-49f0-88c8-c841f73242d82025-08-28WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
good neighbor pharmacy childrens ibuprofenIBUPROFENAmerisource Bergen7a314b7f-91d6-4196-bd96-2470ff7b0b252025-08-28WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359
childrens ibuprofenIBUPROFENKroger Company1b78bdeb-efb2-4f5a-af3f-d67d820908472025-08-22WarningsExact identifier
application applno (ANDA): 076359
application number: ANDA076359

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0788-62001130788621 BOTTLE in 1 CARTON (0113-0788-62) > 24 TABLET, CHEWABLE in 1 BOTTLE1 bottle2017-12-190000-00-00NoNoCurrent