FDA.reportPublic FDA data

CHILDRENS ADVIL

Product NDC
0573-0232
11-digit product format
005730232
Labeler code
0573
Product ID
0573-0232_88972802-d04c-4fe3-8c56-3c3d1e3b4218
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA020589
Marketing category
NDA
Marketing start
2013-12-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CHILDRENS ADVIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803, 206878

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0232-30CHILDRENS ADVIL120 mL in 1 BOTTLESUSPENSION12020
0573-0232-30CHILDRENS ADVIL1 in 1 CARTONSUSPENSION120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0232-30ML - Milliliter0573-0232e109c495-07f6-4cfc-abad-c78f1acf970612015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
IBUPROFENACTIVE MOIETYWK2XYI10QMCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311CHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
PROPYLENE GLYCOL, (R)-INACTIVE INGREDIENT602HN5L69HCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0232CHILDRENS ADVIL (IBUPROFEN) SUSPENSION [HALEON US HOLDINGS LLC]20Current NDC, Legacy NDC, 2 package rows20240209_3079d932-afb2-94fe-f4ba-a3d8b5198fce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206878Advil Children 100 MG in 5 mL Oral SuspensionPSN3079d932-afb2-94fe-f4ba-a3d8b5198fce20
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN3079d932-afb2-94fe-f4ba-a3d8b5198fce20
206878ibuprofen 20 MG/ML Oral Suspension [Advil]SBD3079d932-afb2-94fe-f4ba-a3d8b5198fce20
197803ibuprofen 20 MG/ML Oral SuspensionSCD3079d932-afb2-94fe-f4ba-a3d8b5198fce20
206878Advil 100 MG per 5 ML Oral SuspensionSY3079d932-afb2-94fe-f4ba-a3d8b5198fce20
206878Advil 20 MG/ML Oral SuspensionSY3079d932-afb2-94fe-f4ba-a3d8b5198fce20
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY3079d932-afb2-94fe-f4ba-a3d8b5198fce20
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY3079d932-afb2-94fe-f4ba-a3d8b5198fce20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0232-30005730232301 BOTTLE in 1 CARTON (0573-0232-30) / 120 mL in 1 BOTTLE1 bottle2013-12-200000-00-00NoNoCurrent