Indications and uses
temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
• this product does not contain directions or complete warnings for adult use • do not give more than directed • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise use age. • mL = milliliter • measure with the dosing device provided. Do not use with any other device. • dispense liquid slowly into the child’s mouth, toward the inner cheek • if needed, repeat dose ev...
• store at 20-25°C (68-77°F) • do not freeze • do not use if printed neckband is broken or missing
Ibuprofen 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily:
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 your child:
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.
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Dosing Chart | ||
Weight (lbs) | Age (mos) | Dose (mL) |
under 6 mos | ask a doctor | |
12-17 lbs | 6-11 mos | 1.25 mL |
18-23 lbs | 12-23 mos | 1.875 mL |
anhydrous citric acid, FD&C red #40, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
1-888-423-0139
TopCare® health
COMPARE TO MOTRIN® INFANTS’ DROPS ACTIVE INGREDIENT
FOR AGES 6 MOS. TO 23 MOS.
SEE NEW WARNINGS
CONCENTRATED DROPS
infants’ Ibuprofen
ORAL SUSPENSON
50 mg per 1.25 mL
PAIN RELIEVER
FEVER REDUCER (NSAID)
Lasts up to 8 HOURS
• No High Fructose Corn Syrup
Use only with enclosed syringe.
Ages 6 mos. to 23 mos.
BERRY FLAVOR
0.5 FL OZ (15 mL)

| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-057-05 | Topcare Infants Ibuprofen | 15 mL in 1 BOTTLE | SUSPENSION | 15 | 7 | |
| 36800-057-05 | Topcare Infants Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 7 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 36800-057-05 | ML - Milliliter | 36800-057 | adaf968a-cad7-4ced-b95d-d25c6fbda19a | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 3 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 3 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 3 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 3 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 36800-057 | 36800-057-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
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 |
|---|---|---|---|---|---|---|
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / ORAL | 206 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / ORAL | 206 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 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 |
|---|---|---|---|---|---|---|---|
| A075217-001 | IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 |
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 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 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 |
|---|---|---|---|---|---|---|
| Topcare Infants Ibuprofen | IBUPROFEN | Topco Associates LLC | 00d33273-e8c7-4d40-8e6f-a980f746fff2 | 2025-05-03 | Warnings | 36800-057-05 36800-057 36800005705 f581be63-9628-433f-8a31-eba6f530254e 00d33273-e8c7-4d40-8e6f-a980f746fff2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.