Childrens Ibuprofen

Product NDC
55154-1577
11-digit product format
551541577
Labeler code
55154
Product ID
55154-1577_fbdc0403-6c4d-47af-a5c8-f3e4811712aa
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA074937
Marketing category
ANDA
Marketing start
2004-04-13
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

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
55154-1577-5Childrens Ibuprofen5 in 1 BAGSUSPENSION511
55154-1577-5Childrens Ibuprofen5 mL in 1 CUP, UNIT-DOSESUSPENSION511

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
IbuprofenACTIVE MOIETYWK2XYI10QMCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
butylparabenINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
corn syrupINACTIVE INGREDIENT9G5L16BK6NCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
D&C red NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
FD&C yellow NO. 6INACTIVE INGREDIENTH77VEI93A8CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
xanthan gumINACTIVE INGREDIENTTTV12P4NEECHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-1577CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH 107, LLC]9Current NDC, Legacy NDC, 2 package rows20250313_9291857c-30b3-414b-99e1-9c127e72c0d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN9291857c-30b3-414b-99e1-9c127e72c0d411
197803ibuprofen 20 MG/ML Oral SuspensionSCD9291857c-30b3-414b-99e1-9c127e72c0d411
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY9291857c-30b3-414b-99e1-9c127e72c0d411
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY9291857c-30b3-414b-99e1-9c127e72c0d411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-1577-5551541577055 CUP, UNIT-DOSE in 1 BAG (55154-1577-5) / 5 mL in 1 CUP, UNIT-DOSE2004-04-130000-00-00NoNoCurrent