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 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets 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 caplet)
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.
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 58602-801-21
Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Coated Caplets* *Capsule-Shaped Tablets
AUROHEALTH
NDC 58602-801-21
#Compare to the active
ingredient of MOTRIN® IB
Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Coated Caplets* *Capsule-Shaped 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 |
|---|---|---|---|---|---|---|
| 58602-801-07 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-801-07 | Ibuprofen | 24 in 1 BOTTLE | TABLET | 24 | 3 | |
| 58602-801-12 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-801-12 | Ibuprofen | 40 in 1 BOTTLE | TABLET | 40 | 3 | |
| 58602-801-14 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-801-14 | Ibuprofen | 50 in 1 BOTTLE | TABLET | 50 | 3 | |
| 58602-801-15 | Ibuprofen | 60 in 1 BOTTLE | TABLET | 60 | 3 | |
| 58602-801-15 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-801-19 | Ibuprofen | 90 in 1 BOTTLE | TABLET | 90 | 3 | |
| 58602-801-19 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-801-21 | Ibuprofen | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 58602-801-21 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-801-29 | Ibuprofen | 150 in 1 BOTTLE | TABLET | 150 | 3 | |
| 58602-801-29 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-801-34 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-801-34 | Ibuprofen | 200 in 1 BOTTLE | TABLET | 200 | 3 | |
| 58602-801-35 | Ibuprofen | 225 in 1 BOTTLE | TABLET | 225 | 3 | |
| 58602-801-35 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-801-36 | Ibuprofen | 250 in 1 BOTTLE | TABLET | 250 | 3 | |
| 58602-801-36 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 58602-801-38 | Ibuprofen | 300 in 1 BOTTLE | TABLET | 300 | 3 | |
| 58602-801-40 | Ibuprofen | 500 in 1 BOTTLE | TABLET | 500 | 3 | |
| 58602-801-41 | Ibuprofen | 1000 in 1 BOTTLE | TABLET | 1000 | 3 | |
| 58602-801-59 | Ibuprofen | 1500 in 1 BOTTLE | TABLET | 1500 | 3 | |
| 58602-801-87 | Ibuprofen | 550 in 1 BOTTLE | TABLET | 550 | 3 | |
| 58602-801-88 | Ibuprofen | 750 in 1 BOTTLE | TABLET | 750 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-801 | 58602-801-07, 58602-801-12, 58602-801-14, 58602-801-15, 58602-801-19, 58602-801-21, 58602-801-29, 58602-801-34, 58602-801-35, 58602-801-36, 58602-801-38, 58602-801-40, 58602-801-87, 58602-801-88, 58602-801-41, 58602-801-59 |
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 | 0ade8ee2-7c74-4b05-925e-d92742fc2b90 | 2022-03-03 | Warnings | 58602-801-07 58602-801-88 58602-801-87 58602-801-40 58602-801-35 58602-801-15 58602-801-29 58602-801-41 58602-801-21 58602-801-14 58602-801-34 58602-801-59 58602-801-36 58602-801-12 58602-801-38 58602-801-19 58602-801 58602080187 58602080115 58602080138 58602080188 58602080140 58602080107 58602080141 58602080159 58602080114 58602080112 58602080135 58602080134 58602080121 58602080136 58602080119 58602080129 19309ddd-73dc-462a-afaa-899834a2d783 0ade8ee2-7c74-4b05-925e-d92742fc2b90 |
Adverse event summaries are temporarily unavailable. Other product information remains available.