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 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor
store between 20° to 25°C (68° to 77°F) do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing. see top panel for lot number and expiration date
Active ingredient (in each tablet)
Ibuprofen USP 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/Fever reducer
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if you:
Heart attack and stroke warning: 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.
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear
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)
| adults and children 12 years and older |
|
| children under 12 years |
|
colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide
Questions or comments?
Call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road,
East Windsor, NJ 08520
Code No.: TS/DRUGS/22/2009
Made in India
NDC 58602-802-21
Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Coated Tablets
AUROHEALTH
NDC 58602-802-21
#Compare to the active
ingredient of MOTRIN® IB
Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Coated Tablets
AUROHEALTH
| 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 |
| 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 |
|---|---|---|---|---|---|---|
| 58602-802-07 | Ibuprofen | 24 in 1 BOTTLE | TABLET | 24 | 3 | |
| 58602-802-07 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-802-14 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-802-14 | Ibuprofen | 50 in 1 BOTTLE | TABLET | 50 | 3 | |
| 58602-802-21 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-802-21 | Ibuprofen | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 58602-802-29 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-802-29 | Ibuprofen | 150 in 1 BOTTLE | TABLET | 150 | 3 | |
| 58602-802-34 | Ibuprofen | 200 in 1 BOTTLE | TABLET | 200 | 3 | |
| 58602-802-38 | Ibuprofen | 300 in 1 BOTTLE | TABLET | 300 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-802 | 58602-802-07, 58602-802-14, 58602-802-21, 58602-802-29, 58602-802-34, 58602-802-38 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|---|
| A208865-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 |
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 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A208865-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-11-08 | 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 | Aurohealth LLC | cf6fbf3b-a0f3-4e08-a981-d183fa285758 | 2022-03-03 | Warnings | 58602-802-07 58602-802-21 58602-802-14 58602-802-29 58602-802-34 58602-802-38 58602-802 58602080207 58602080229 58602080234 58602080221 58602080238 58602080214 5e6a6cce-b25c-4d6c-9d58-b4db175c6f8e cf6fbf3b-a0f3-4e08-a981-d183fa285758 |
Adverse event summaries are temporarily unavailable. Other product information remains available.