FDA.reportPublic FDA data

Advil

Product NDC
0573-0134
11-digit product format
005730134
Labeler code
0573
Product ID
0573-0134_40429ef4-846a-eb4c-e063-6394a90ab7a9
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA201803
Marketing category
NDA
Marketing start
2013-07-08
Substance
IBUPROFEN SODIUM
Active strength
256 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
Advil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN SODIUM256 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRM1CE97Z4N
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
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
0573-0134-202024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0134-802024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0134-20Advil1 in 1 CARTONTABLET, COATED120
0573-0134-20Advil20 in 1 BOTTLETABLET, COATED2020
0573-0134-80Advil1 in 1 CARTONTABLET, COATED120
0573-0134-80Advil80 in 1 BOTTLETABLET, COATED8020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0134-20EA - Each0573-013452f8dbba-05c8-44cc-bcb9-b13a739732b812024-04-05
0573-0134-80EA - Each0573-0134197e44be-693b-4b34-8839-0bdb4073ae8812024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFEN SODIUMACTIVE INGREDIENTRM1CE97Z4NADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
IBUPROFENACTIVE MOIETYWK2XYI10QMADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
MANNITOLINACTIVE INGREDIENT3OWL53L36AADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0134ADVIL (IBUPROFEN SODIUM) TABLET, COATED [HALEON US HOLDINGS LLC]19Current NDC, Legacy NDC, 4 package rows20240625_5be198b8-396e-4b44-8819-e2e3b5d2ad0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153008Advil 200 MG Oral TabletPSN5be198b8-396e-4b44-8819-e2e3b5d2ad0e20
310965ibuprofen 200 MG Oral TabletPSN5be198b8-396e-4b44-8819-e2e3b5d2ad0e20
153008ibuprofen 200 MG Oral Tablet [Advil]SBD5be198b8-396e-4b44-8819-e2e3b5d2ad0e20
310965ibuprofen 200 MG Oral TabletSCD5be198b8-396e-4b44-8819-e2e3b5d2ad0e20
153008Advil 200 MG Oral TabletSY5be198b8-396e-4b44-8819-e2e3b5d2ad0e20
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY5be198b8-396e-4b44-8819-e2e3b5d2ad0e20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0134-20005730134201 BOTTLE in 1 CARTON (0573-0134-20) / 20 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent
0573-0134-80005730134801 BOTTLE in 1 CARTON (0573-0134-80) / 80 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent