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
• read all warnings and directions before use • store at 20-25°C (68-77°F) • avoid high humidity and excessive heat above 40°C (104°F)
Ibuprofen 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 chances are 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 during the last 3 months of 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: ask a doctor
colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide
1-888-423-0139
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 36800-183-83 | EA - Each | 36800-183 | 723b4701-f3ba-408d-a46e-36e6751b60db | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 2 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 36800-183 | 36800-183-83 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | TABLET, FILM COATED / ORAL | 20 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| TALC | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg | ||
| TALC | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE, FOR SUSPENSION / ORAL | 282 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 64 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg |
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 |
|---|---|---|---|---|---|---|---|
| A077349-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 |
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 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 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 |
|---|---|---|---|---|---|---|
| 4dcf79fb-8cac-4dd7-a295-a7b339769801 | fac7af67-dd2f-40c1-a310-a7fa8fc90a9e | 2021-11-11 | Warnings | 4dcf79fb-8cac-4dd7-a295-a7b339769801 fac7af67-dd2f-40c1-a310-a7fa8fc90a9e |
Adverse event summaries are temporarily unavailable. Other product information remains available.