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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020603-001CHILDREN'S MOTRINIBUPROFEN40MG/MLSUSPENSION/DROPS / ORALRLD, RS1996-06-10

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Infants MotrinIBUPROFENKenvue Brands LLCc2302bfe-b367-4867-b803-29f066a42dc72026-06-30WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters 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: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed 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. Do not use if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts mo...

Additional Listing Data#

Finished product
Yes
Brand name base
Infants Motrin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN50 mg/1.25mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui204442, 854762

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-100-18Infants Motrin15 mL in 1 BOTTLESUSPENSION/ DROPS159
50580-100-18Infants Motrin1 in 1 CARTONSUSPENSION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-100-18ML - Milliliter50580-10025ce273d-b30a-4d0d-a333-5e7155c025e212016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMINFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
IbuprofenACTIVE MOIETYWK2XYI10QMINFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLINFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
caramelINACTIVE INGREDIENTT9D99G2B1RINFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOAINFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXINFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HINFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUINFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
sorbitolINACTIVE INGREDIENT506T60A25RINFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
sucroseINACTIVE INGREDIENTC151H8M554INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
waterINACTIVE INGREDIENT059QF0KO0RINFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEEINFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-100INFANTS MOTRIN (IBUPROFEN) SUSPENSION/ DROPS [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 2 package rows20250124_c2302bfe-b367-4867-b803-29f066a42dc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSNc2302bfe-b367-4867-b803-29f066a42dc79
854762Motrin Infant Drops Concentrated 50 MG in 1.25 mL Oral SuspensionPSNc2302bfe-b367-4867-b803-29f066a42dc79
854762ibuprofen 40 MG/ML Oral Suspension [Motrin]SBDc2302bfe-b367-4867-b803-29f066a42dc79
204442ibuprofen 40 MG/ML Oral SuspensionSCDc2302bfe-b367-4867-b803-29f066a42dc79
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSYc2302bfe-b367-4867-b803-29f066a42dc79
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSYc2302bfe-b367-4867-b803-29f066a42dc79
854762Infants' Motrin 40 MG/ML Oral SuspensionSYc2302bfe-b367-4867-b803-29f066a42dc79
854762Motrin 40 MG/ML Oral SuspensionSYc2302bfe-b367-4867-b803-29f066a42dc79
854762Motrin Infant Drops 50 MG per 1.25 ML Oral SuspensionSYc2302bfe-b367-4867-b803-29f066a42dc79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-100-18505800100181 BOTTLE in 1 CARTON (50580-100-18) / 15 mL in 1 BOTTLE1 bottle2012-05-150000-00-00NoNoCurrent