IBUPROFEN

Manufacturer
DIRECT RX
Effective date
2025-01-20
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-05-31 21:23:23

Label at a glance#

ProductIBUPROFEN
Active ingredientIBUPROFEN
Label structure15 sections

Label contents#

Full prescribing information#

SPL MEDGUIDE SECTION

[MEDGUIDE IBUPROFEN TABLETS]

HOW SUPPLIED SECTION

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500

HOW SUPPLIED SECTION

600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500

HOW SUPPLIED SECTION

800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘123’ on one side and plain on other side)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

231231

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

266266

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hihi

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hjshdkshfkjhjshdkshfkj

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6783648276467836482764

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

yugthgistuegyugthgistueg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

yugthgistuegyugthgistueg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72189-231-9072189-231-90

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72189-231-6072189-231-60

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72189-231-3072189-231-30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72189-266-1572189-266-15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197806ibuprofen 600 MG Oral TabletPSN11
197807ibuprofen 800 MG Oral TabletPSN11
197806ibuprofen 600 MG Oral TabletSCD11
197807ibuprofen 800 MG Oral TabletSCD11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

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
72189-231-21IBUPROFEN21 in 1 BOTTLETABLET, FILM COATED2111
72189-231-30IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED3011
72189-231-60IBUPROFEN60 in 1 BOTTLETABLET, FILM COATED6011
72189-231-90IBUPROFEN90 in 1 BOTTLETABLET, FILM COATED9011
72189-266-15IBUPROFEN15 in 1 BOTTLETABLET, FILM COATED1511
72189-266-30IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED3011
72189-266-40IBUPROFEN40 in 1 BOTTLETABLET, FILM COATED4011
72189-266-60IBUPROFEN60 in 1 BOTTLETABLET, FILM COATED6011
72189-266-71IBUPROFEN100 in 1 BOTTLETABLET, FILM COATED10011
72189-266-72IBUPROFEN120 in 1 BOTTLETABLET, FILM COATED12011
72189-266-90IBUPROFEN90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-231IBUPROFEN TABLET, FILM COATED [DIRECT RX]11Current NDC, Legacy NDC, 4 package rows20250121_c3f30813-0848-6e8a-e053-2995a90a3dea.zip
72189-266IBUPROFEN TABLET, FILM COATED [DIRECT RX]11Current NDC, Legacy NDC, 7 package rows20250121_c3f30813-0848-6e8a-e053-2995a90a3dea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-231-21EA - Each72189-231c4f10e50-62ff-49ce-9179-88cb7ffa156912021-07-15
72189-231-30EA - Each72189-2313d9ce86a-1c3f-4b40-aae6-17125844431f12022-11-07
72189-231-60EA - Each72189-231ad08779f-2bbe-43a5-bac8-c044fe347b7912021-12-08
72189-266-15EA - Each72189-266dc7ac00e-9214-4201-a6be-71e538d5638b12022-03-09
72189-266-30EA - Each72189-266f44d3f61-391b-4462-835e-c18de5f1b44412022-07-06
72189-266-40EA - Each72189-266b360d924-dfa1-477b-ac95-f52e565809b212021-10-08
72189-266-60EA - Each72189-2662022e072-c0b1-4287-85fe-696c81726cd712022-02-07
72189-266-71EA - Each72189-2660e5026a0-f904-4827-aaa9-d6298be1968f12021-11-09
72189-266-72EA - Each72189-266db3c2592-136f-4b86-a273-96135df831da12022-02-07
72189-266-90EA - Each72189-266691aa9da-d86b-41ed-967d-2bc8a56f3aae12021-10-08
49483-604-01EA - Each49483-6044c978774-cbdd-4eda-a974-dfea4b1a311012016-01-13
49483-604-50EA - Each49483-6043bc46c7c-6ff6-423b-9ef0-88aec4a6d29712016-01-13
49483-603-01EA - Each49483-603e94af99e-6f7b-42c9-829a-3b8711a49f3c12016-01-13
49483-603-50EA - Each49483-603675d2dd5-ece0-4712-bfad-b791ae2a047a12016-01-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090796-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2010-12-21
A090796-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2010-12-21
A090796-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2010-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090796-001AB
A090796-002AB
A090796-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-2184e616aacf4f…
2026-09-14 22:38:342026-08A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-2184e616aacf4f…
2026-09-14 22:38:342026-08A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-2184e616aacf4f…
2026-08-18 06:07:402026-07A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090796-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090796-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090796-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A090796-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090796-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090796-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090796-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090796-001AB1301d65b070ca…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENDIRECT RXc3f30813-0848-6e8a-e053-2995a90a3dea2025-01-20Exact identifier
ndc (package): 72189-231-90
ndc (package): 72189-266-71
ndc (package): 72189-231-60
ndc (package): 72189-231-21
ndc (package): 72189-266-72
ndc (package): 72189-266-90
ndc (package): 72189-266-60
ndc (package): 72189-231-30
ndc (package): 72189-266-15
ndc (package): 72189-266-30
ndc (package): 72189-266-40
ndc (product): 72189-266
ndc (product): 72189-231
ndc11 (package): 72189026640
ndc11 (package): 72189026672
ndc11 (package): 72189023190
ndc11 (package): 72189026690
ndc11 (package): 72189023121
ndc11 (package): 72189026630
ndc11 (package): 72189026660
ndc11 (package): 72189026671
ndc11 (package): 72189026615
ndc11 (package): 72189023160
ndc11 (package): 72189023130
spl id: 2c285455-94b8-8154-e063-6394a90a0e8c
spl set id: c3f30813-0848-6e8a-e053-2995a90a3dea
IbuprofenIBUPROFENTIME CAP LABORATORIES, INCec3e8443-d742-4c25-8516-f0df4ebfccdc2024-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 49483-604
ndc (product): 49483-603

Reported adverse events (FAERS/openFDA)#

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