Ibuprofen

Product NDC
0904-7915
11-digit product format
009047915
Labeler code
0904
Product ID
0904-7915_012127a4-f871-4289-9fd5-c91cd1a986f5
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1988-05-24
Marketing end
2021-11-15
Substance
IBUPROFEN
Active strength
200 mg/1
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 productproduct0904-7915DDiscontinued by firm2026-10-05
excluded packagepackage0904-79150904-7915-80DDiscontinued by firm2026-10-05

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 packagepackage0904-7915-80d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-7915-80f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-7915-802ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-7915-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-7915-80cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-7915-80cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-7915-80302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-7915-80ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-7915-800efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-7915-80ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-7915-80367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-7915-80557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7915-24EA - Each0904-79150ebdac4b-1423-4631-bd60-3aa7a719617012013-02-13
0904-7915-40EA - Each0904-7915c84dc8bb-62dd-4b45-a91f-796d05fd602712013-02-13
0904-7915-51EA - Each0904-79153fe69536-1766-4963-acb3-21a88838668812013-02-13
0904-7915-59EA - Each0904-7915e3a622d9-4151-4d28-bb86-3432d0d0809f12013-02-13
0904-7915-70EA - Each0904-7915c84e7340-52bf-4996-9009-03bc868e8be912013-02-13
0904-7915-80EA - Each0904-791509add50d-10b5-4ab8-97f7-db45326bb4e912013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3569
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3569
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3569
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3569
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GIBUPROFEN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3569
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3569
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3569
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3569
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3569
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3569
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GIBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [DIRECT RX]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [DIRECT RX]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [DIRECT RX]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GIBUPROFEN TABLET, FILM COATED [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [DIRECT RX]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [DIRECT RX]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [DIRECT RX]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [DIRECT RX]3
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [TYA PHARMACEUTICALS]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [TYA PHARMACEUTICALS]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GIBUPROFEN TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GIBUPROFEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN84d86fd2-24c4-438f-a8ba-2002b10bacdf3
310965ibuprofen 200 MG Oral TabletSCD84d86fd2-24c4-438f-a8ba-2002b10bacdf3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY84d86fd2-24c4-438f-a8ba-2002b10bacdf3
310965ibuprofen 200 MG Oral TabletPSN166f18b9-b240-4af7-a6a1-029cfabfc0522
310965ibuprofen 200 MG Oral TabletSCD166f18b9-b240-4af7-a6a1-029cfabfc0522
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY166f18b9-b240-4af7-a6a1-029cfabfc0522
310965ibuprofen 200 MG Oral TabletPSNbeec2bfd-1ba9-46b2-84f0-6a47766048e41
310965ibuprofen 200 MG Oral TabletPSNec219fae-1b21-405f-939d-992b7ccc38c11
310965ibuprofen 200 MG Oral TabletSCDbeec2bfd-1ba9-46b2-84f0-6a47766048e41
310965ibuprofen 200 MG Oral TabletSCDec219fae-1b21-405f-939d-992b7ccc38c11
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYbeec2bfd-1ba9-46b2-84f0-6a47766048e41
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYec219fae-1b21-405f-939d-992b7ccc38c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-7915-80009047915801 BOTTLE, PLASTIC in 1 CARTON (0904-7915-80) > 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242021-11-15NoNoCurrent