ibuprofen tablets 400 mg - 600 mg- 800 mg medguide
IBUPROFEN
- Manufacturer
- RedPharm Drug, Inc.
- Effective date
- 2024-07-25
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 21:09:03
Label at a glance#
ProductIBUPROFEN
Active ingredientIBUPROFEN
Label structure12 sections
Label contents#
Full prescribing information#
HOW SUPPLIED
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
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)
400mg Ibuprofen 100 count label
400 mg 500 count label
600 mg 100 count label
800 mg 100 count label
600 MG 500 COUNT LABEL
800 MG 500 COUNT LABEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67296-1756-1 | 2026-01-29 | C162847 | 48780-1 | 1030e365-1d36-111a-e063-dadaa90a10e2 | IBUPROFEN 800mg |
| 67296-1756-3 | 2026-01-29 | C162847 | 48780-1 | 1030e365-1d36-111a-e063-dadaa90a10e2 | IBUPROFEN 800mg |
| 67296-1756-1 | 2024-07-25 | C162847 | 48780-1 | 1030e365-1d36-111a-e063-dadaa90a10e2 | IBUPROFEN 800mg |
| 67296-1756-3 | 2024-07-25 | C162847 | 48780-1 | 1030e365-1d36-111a-e063-dadaa90a10e2 | IBUPROFEN 800mg |
| 67296-1756-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1d36-111a-e063-dadaa90a10e2 | IBUPROFEN 800mg |
| 67296-1756-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1d36-111a-e063-dadaa90a10e2 | IBUPROFEN 800mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-1756-1 | IBUPROFEN | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 5 | |
| 67296-1756-3 | IBUPROFEN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67296-1756 | IBUPROFEN TABLET, FILM COATED [REDPHARM DRUG, INC.] | 5 | Legacy NDC, 2 package rows | 20240727_a2f3b793-171c-2bde-e053-2995a90a62a0.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49483-604-01 | EA - Each | 49483-604 | 4c978774-cbdd-4eda-a974-dfea4b1a3110 | 1 | 2016-01-13 |
| 49483-604-50 | EA - Each | 49483-604 | 3bc46c7c-6ff6-423b-9ef0-88aec4a6d297 | 1 | 2016-01-13 |
Products#
Every source-derived product name is available through these pages.
- IBUPROFEN
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL
- STARCH, PREGELATINIZED CORN
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67296-1756 | 67296-1756-3, 67296-1756-1 |
| 49483-604 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POLYVINYL ALCOHOL | 532B59J990 | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090796-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | |
| A090796-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | |
| A090796-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090796-001 | AB |
| A090796-002 | AB |
| A090796-003 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090796-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090796-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090796-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090796-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090796-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090796-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-001 | AB | 1 | 301d65b070ca… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | TIME CAP LABORATORIES, INC | ec3e8443-d742-4c25-8516-f0df4ebfccdc | 2024-11-21 | Boxed warning, Warnings, Adverse reactions | 49483-604 |
| 1e1cbc06-5510-cbb2-e063-6294a90a5f4b | a2f3b793-171c-2bde-e053-2995a90a62a0 | 2024-07-25 | 1e1cbc06-5510-cbb2-e063-6294a90a5f4b a2f3b793-171c-2bde-e053-2995a90a62a0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.