Infants Motrin
- Product NDC
- 50580-100
- 11-digit product format
- 505800100
- Labeler code
- 50580
- Product ID
- 50580-100_2bcd0083-0ce4-1d04-e063-6294a90a8b97
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION/ DROPS
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- NDA020603
- Marketing category
- NDA
- Marketing start
- 2004-06-01
- Substance
- IBUPROFEN
- Active strength
- 50 mg/1.25mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Infants Motrin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 50 mg/1.25mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 204442, 854762 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-100-18 | Infants Motrin | 15 mL in 1 BOTTLE | SUSPENSION/ DROPS | 15 | | 9 |
| 50580-100-18 | Infants Motrin | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ibuprofen | ACTIVE INGREDIENT | WK2XYI10QM | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
| Ibuprofen | ACTIVE MOIETY | WK2XYI10QM | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
| caramel | INACTIVE INGREDIENT | T9D99G2B1R | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-100 | INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [KENVUE BRANDS LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250124_c2302bfe-b367-4867-b803-29f066a42dc7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50580-100-18 | 50580010018 | 1 BOTTLE in 1 CARTON (50580-100-18) / 15 mL in 1 BOTTLE | 1 bottle | 2012-05-15 | 0000-00-00 | No | No | Current |