FDA.reportPublic FDA data

JUNIOR STRENGTH ADVIL

Product NDC
0573-0175
11-digit product format
005730175
Labeler code
0573
Product ID
0573-0175_ef08fcca-c3f3-4179-a042-bbd9f6733e58
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA020267
Marketing category
NDA
Marketing start
2011-06-21
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
Rxcui198405, 731535

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0175-112024-01-30C16284748780-11030e365-3b6e-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0175-11JUNIOR STRENGTH ADVIL1 in 1 CARTONTABLET, COATED17
0573-0175-11JUNIOR STRENGTH ADVIL24 in 1 BOTTLETABLET, COATED247

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0175-11EA - Each0573-0175a2dae660-67f7-4253-8c0f-08cb0a5d9c0912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
IBUPROFENACTIVE MOIETYWK2XYI10QMJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48JUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
DIACETYLATED MONOGLYCERIDESINACTIVE INGREDIENT5Z17386USFJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
SHELLACINACTIVE INGREDIENT46N107B71OJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4JUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
SUCROSEINACTIVE INGREDIENTC151H8M554JUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPJUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0175JUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 2 package rows20240423_5ed0d404-c54d-b05f-578a-d2730e8a78ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731535Advil Junior Strength 100 MG Oral TabletPSN5ed0d404-c54d-b05f-578a-d2730e8a78ee7
198405ibuprofen 100 MG Oral TabletPSN5ed0d404-c54d-b05f-578a-d2730e8a78ee7
731535ibuprofen 100 MG Oral Tablet [Advil]SBD5ed0d404-c54d-b05f-578a-d2730e8a78ee7
198405ibuprofen 100 MG Oral TabletSCD5ed0d404-c54d-b05f-578a-d2730e8a78ee7
731535Advil 100 MG Oral TabletSY5ed0d404-c54d-b05f-578a-d2730e8a78ee7
731535Junior Strength Advil 100 MG Oral TabletSY5ed0d404-c54d-b05f-578a-d2730e8a78ee7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0175-11005730175111 BOTTLE in 1 CARTON (0573-0175-11) / 24 TABLET, COATED in 1 BOTTLE1 bottle2011-06-210000-00-00NoNoCurrent