Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
do not take more than directed the smallest effective dose should be used adults and children 12 years and older take 1 captet every 4 to 6 hours while symptoms persist • If pain or fever does not respond to 1 captet, 2 captets may be used • do not exceed 6 captets in 24 hours, unless directed by a doctor. children under 12 years ask a doctor
store between 20 – 25°C (68 – 77°F). do not use if neck wrap or foil inner seal is broken or missing
Ibuprofen 200 mg (NSAID)
*nonsteroidal anti-inflammatory drug
Pain reliever/ fever reducer
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
hives facial swelling asthma (wheezing)
shock skin reddening rash blisters
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chances is higher if you:
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you
use more than directed or for longer than directed
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
colloidal silicon dioxide, FD&C Yellow #6, maize starch, polyethylene glycol, polyvinyl alcohol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
Call 1-877- 770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| 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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-9593-21 | Ibuprofen | 225 in 1 BOTTLE | TABLET | 225 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-9593 | 0363-9593-21 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202312-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 |
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 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | f41ea6bd6efb… |
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 | Walgreens | 07edb8d0-2fa8-4b40-e063-6294a90a2fe9 | 2025-12-19 | Warnings | 0363-9593-21 0363-9593 00363959321 46549a71-13b9-ea53-e063-6294a90aef35 07edb8d0-2fa8-4b40-e063-6294a90a2fe9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.