FDA.reportPublic FDA data

ADVIL

Product NDC
0573-1711
11-digit product format
005731711
Labeler code
0573
Product ID
0573-1711_4cd840a6-9554-de58-e063-6394a90ab543
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA018989
Marketing category
NDA
Marketing start
1984-05-18
Substance
IBUPROFEN
Active strength
200 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui153008, 310965

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
0573-1711-142024-01-31C16284748780-11030e365-3639-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-1711-14ADVIL1 in 1 CARTONTABLET, COATED138
0573-1711-14ADVIL225 in 1 BOTTLETABLET, COATED22538

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
IBUPROFENACTIVE MOIETYWK2XYI10QMADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
DIACETYLATED MONOGLYCERIDESINACTIVE INGREDIENT5Z17386USFADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
GELATININACTIVE INGREDIENT2G86QN327LADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
POVIDONESINACTIVE INGREDIENTFZ989GH94EADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
SHELLACINACTIVE INGREDIENT46N107B71OADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
SUCROSEINACTIVE INGREDIENTC151H8M554ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
TRIACETININACTIVE INGREDIENTXHX3C3X673ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
WATERINACTIVE INGREDIENT059QF0KO0RADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-1711ADVIL (IBUPROFEN) TABLET, COATED [HALEON US HOLDINGS LLC]36Current NDC, Legacy NDC, 2 package rows20240410_1a665e64-9f30-be37-4a83-38789f1f1e89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153008Advil 200 MG Oral TabletPSN1a665e64-9f30-be37-4a83-38789f1f1e8938
310965ibuprofen 200 MG Oral TabletPSN1a665e64-9f30-be37-4a83-38789f1f1e8938
153008ibuprofen 200 MG Oral Tablet [Advil]SBD1a665e64-9f30-be37-4a83-38789f1f1e8938
310965ibuprofen 200 MG Oral TabletSCD1a665e64-9f30-be37-4a83-38789f1f1e8938
153008Advil 200 MG Oral TabletSY1a665e64-9f30-be37-4a83-38789f1f1e8938
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1a665e64-9f30-be37-4a83-38789f1f1e8938

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-1711-14005731711141 BOTTLE in 1 CARTON (0573-1711-14) / 225 TABLET, COATED in 1 BOTTLE1 bottle1984-05-180000-00-00NoNoCurrent