FDA.reportPublic FDA data

JUNIOR STRENGTH ADVIL

Product NDC
0573-0179
11-digit product format
005730179
Labeler code
0573
Product ID
0573-0179_60e9724f-3733-45d1-989d-8ee434e91dc0
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA020944
Marketing category
NDA
Marketing start
2011-06-01
Substance
IBUPROFEN
Active strength
100 mg/1
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
JUNIOR STRENGTH ADVIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310963, 731536

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0179-20JUNIOR STRENGTH ADVIL24 in 1 BOTTLETABLET, CHEWABLE249
0573-0179-20JUNIOR STRENGTH ADVIL1 in 1 CARTONTABLET, CHEWABLE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0179-20EA - Each0573-017971775c21-6552-4526-bd9c-89ee836db03612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2
IBUPROFENACTIVE MOIETYWK2XYI10QMJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1JUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2
CELLACEFATEINACTIVE INGREDIENTF2O5O2OI9FJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2
GELATININACTIVE INGREDIENT2G86QN327LJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30JUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4JUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2JUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [PFIZER CONSUMER HEALTHCARE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0179JUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]8Current NDC, Legacy NDC, 2 package rows20230120_07d4c400-b182-92f7-7574-9e0e94c39cce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731536Advil Junior Strength 100 MG Chewable TabletPSN07d4c400-b182-92f7-7574-9e0e94c39cce9
310963ibuprofen 100 MG Chewable TabletPSN07d4c400-b182-92f7-7574-9e0e94c39cce9
731536ibuprofen 100 MG Chewable Tablet [Advil]SBD07d4c400-b182-92f7-7574-9e0e94c39cce9
310963ibuprofen 100 MG Chewable TabletSCD07d4c400-b182-92f7-7574-9e0e94c39cce9
731536Advil 100 MG Chewable TabletSY07d4c400-b182-92f7-7574-9e0e94c39cce9
731536Advil Junior Strength 100 MG Chewable TabletSY07d4c400-b182-92f7-7574-9e0e94c39cce9
731536Advil Junior Strength 100 MG Chewable TabletPSN91fc4794-1880-460f-86dd-49d8c1e872bc1
310963ibuprofen 100 MG Chewable TabletPSN91fc4794-1880-460f-86dd-49d8c1e872bc1
731536ibuprofen 100 MG Chewable Tablet [Advil]SBD91fc4794-1880-460f-86dd-49d8c1e872bc1
310963ibuprofen 100 MG Chewable TabletSCD91fc4794-1880-460f-86dd-49d8c1e872bc1
731536Advil 100 MG Chewable TabletSY91fc4794-1880-460f-86dd-49d8c1e872bc1
731536Advil Junior Strength 100 MG Chewable TabletSY91fc4794-1880-460f-86dd-49d8c1e872bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0179-20005730179201 BOTTLE in 1 CARTON (0573-0179-20) / 24 TABLET, CHEWABLE in 1 BOTTLE1 bottle2011-06-010000-00-00NoNoCurrent