INFANTS ADVIL

Product NDC
0573-0191
11-digit product format
005730191
Labeler code
0573
Product ID
0573-0191_9f156faa-6bf8-483c-837d-050e40ec0cc5
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA020812
Marketing category
NDA
Marketing start
1998-01-30
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 ADVIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN50 mg/1.25mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui204442, 731531

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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
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
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0191-20INFANTS ADVIL15 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS1519
0573-0191-20INFANTS ADVIL1 in 1 CARTONSUSPENSION/ DROPS119
0573-0191-22INFANTS ADVIL15 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS1519
0573-0191-22INFANTS ADVIL1 in 1 CARTONSUSPENSION/ DROPS119
0573-0191-50INFANTS ADVIL1 in 1 CARTONSUSPENSION/ DROPS119
0573-0191-50INFANTS ADVIL30 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS3019
0573-0191-75INFANTS ADVIL22.5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS22.519
0573-0191-75INFANTS ADVIL1 in 1 CARTONSUSPENSION/ DROPS119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0191-20ML - Milliliter0573-0191ad985bce-ff65-4f94-9d70-95470c8dcc8f12012-07-24
0573-0191-50ML - Milliliter0573-019183f4e4ad-64ca-4301-8a3a-6c1e4837d0b112019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
IBUPROFENACTIVE MOIETYWK2XYI10QMINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311INFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
SORBITOLINACTIVE INGREDIENT506T60A25RINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
SUCROSEINACTIVE INGREDIENTC151H8M554INFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
WATERINACTIVE INGREDIENT059QF0KO0RINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEINFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [PFIZER CONSUMER HEALTHCARE]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0191INFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [HALEON US HOLDINGS LLC]19Current NDC, Legacy NDC, 8 package rows20241127_db5ed801-7a7e-3c83-0172-77f914daaa5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731531Advil Infant 50 MG in 1.25 mL Oral SuspensionPSNdb5ed801-7a7e-3c83-0172-77f914daaa5a19
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSNdb5ed801-7a7e-3c83-0172-77f914daaa5a19
731531ibuprofen 40 MG/ML Oral Suspension [Advil]SBDdb5ed801-7a7e-3c83-0172-77f914daaa5a19
204442ibuprofen 40 MG/ML Oral SuspensionSCDdb5ed801-7a7e-3c83-0172-77f914daaa5a19
731531Advil 40 MG/ML Oral SuspensionSYdb5ed801-7a7e-3c83-0172-77f914daaa5a19
731531Advil 50 MG per 1.25 ML Oral SuspensionSYdb5ed801-7a7e-3c83-0172-77f914daaa5a19
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSYdb5ed801-7a7e-3c83-0172-77f914daaa5a19
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSYdb5ed801-7a7e-3c83-0172-77f914daaa5a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0573-0191-20005730191201 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) / 15 mL in 1 BOTTLE, DROPPER1998-01-300000-00-00NoNoCurrent
0573-0191-22005730191221 BOTTLE, DROPPER in 1 CARTON (0573-0191-22) / 15 mL in 1 BOTTLE, DROPPER2014-01-300000-00-00NoNoCurrent
0573-0191-50005730191501 BOTTLE, DROPPER in 1 CARTON (0573-0191-50) / 30 mL in 1 BOTTLE, DROPPER1998-01-300000-00-00NoNoCurrent
0573-0191-75005730191751 BOTTLE, DROPPER in 1 CARTON (0573-0191-75) / 22.5 mL in 1 BOTTLE, DROPPER1998-01-300000-00-00NoNoCurrent