Ibuprofen

Product NDC
41163-185
11-digit product format
411630185
Labeler code
41163
Product ID
41163-185_38de9d77-0739-3546-e063-6394a90a716a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA079205
Marketing category
ANDA
Marketing start
2018-01-01
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
2026-12-31
Current FDA listing
Yes

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 packagepackage41163-18541163-185-04DDiscontinued 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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41163-18541163-185-04DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A079205-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26

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 UTC2026-02A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-263f01610625f2…
2019-09-15 20:21 UTC2019-09A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079205-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-06-26cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310964Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
37eaa3b1-98e9-4fcf-ae74-153bfc35551fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-185-01Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
41163-185-01Ibuprofen20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED205
41163-185-02Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
41163-185-02Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED405
41163-185-03Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED805
41163-185-03Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
41163-185-04Ibuprofen160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1605
41163-185-06Ibuprofen300 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-185IBUPROFEN CAPSULE, LIQUID FILLED [UNITED NATURAL FOODS, INC. DBA UNFI]3Current NDC, Legacy NDC, 8 package rows20230519_37eaa3b1-98e9-4fcf-ae74-153bfc35551f.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENHarris Teeter87ffbf01-54de-45a8-b2a3-367d219278822026-07-29WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
Ibuprofen MinisIBUPROFENGrocery Outlet, Inc.44665e3d-37a7-a1a7-e063-6294a90ab3762026-03-04WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENWALGREENS40a1e525-fb1e-08f4-e063-6294a90adfa72026-01-14WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCe0a8315a-80a5-4be3-aad1-3d01f00df4942025-12-29WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENAMERIFOODS TRADING COMPANY3802ebc9-83ca-602a-e063-6294a90a11c82025-11-20WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENBJWC (Berkley & Jensen / BJ's)2f322afb-bfc8-9dab-e063-6394a90a08b52025-08-19WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENFSA STORE INC.ec6b1b86-46fc-7e82-e053-2a95a90ac1472025-08-12WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENMARC GLASSMAN, INC.7f366669-9d31-46c7-932d-02fa64b11f302025-07-15WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI37eaa3b1-98e9-4fcf-ae74-153bfc35551f2025-07-01WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
ndc (product): 41163-185
IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLC2810122e-3c89-49a2-8dac-db3714cb7b452024-12-30WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENWinco Foods, LLC61cd9140-eded-4bcf-894b-a163fa5f3e102024-12-06WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
PROPRINALIBUPROFEN CAPSULES 200 MGHART Healthec27b625-a3fa-4c5f-8134-c9373c09b3e32024-12-04WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb619068-be71-7569-e053-2a95a90a4a6e2024-10-26WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENKroger Companybc178013-ab2e-04f5-e053-2995a90a1ed42024-04-13WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENKROGER COMPANY0fbe42d0-b5f0-0780-e063-6394a90a4ecb2024-04-13WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENWALGREENS3ce5b71b-f841-444f-bf66-023e4bd9aa162024-03-15WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
PROPRINALIBUPROFEN CAPSULES 200 MGA-S Medication Solutions4723dd14-5d20-4a9a-b127-4237d5db59562024-01-29WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IBUPROFENIBUPROFENTARGET CORPORATION8e8646fe-fd62-1662-e053-2a95a90a30082024-01-03WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
Ibuprofen MiniIBUPROFEN MINI 200 MGTARGET CORPORATIONc80426d9-e121-c24d-e053-2a95a90acf2f2024-01-03WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205
IbuprofenIBUPROFENTIME CAP LABORATORIES, INC.059cb22f-f6db-5d03-e063-6294a90a9ec12023-10-27WarningsExact identifier
application applno (ANDA): 079205
application number: ANDA079205

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN37eaa3b1-98e9-4fcf-ae74-153bfc35551f5
310964ibuprofen 200 MG Oral CapsuleSCD37eaa3b1-98e9-4fcf-ae74-153bfc35551f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-185-01411630185011 BOTTLE, PLASTIC in 1 CARTON (41163-185-01) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-010000-00-00NoNoCurrent
41163-185-02411630185021 BOTTLE, PLASTIC in 1 CARTON (41163-185-02) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-010000-00-00NoNoCurrent
41163-185-03411630185031 BOTTLE, PLASTIC in 1 CARTON (41163-185-03) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-010000-00-00NoNoCurrent
41163-185-0441163018504160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (41163-185-04) 2018-01-010000-00-00NoNoCurrent
41163-185-0641163018506300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (41163-185-06) 2018-01-010000-00-00NoNoCurrent