FDA.reportPublic FDA data

Advil

Product NDC
0573-0133
11-digit product format
005730133
Labeler code
0573
Product ID
0573-0133_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
0573-0133-012024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-022024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-042024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-052024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-202024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-402024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-412024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-802024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-812024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-882024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-892024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-912024-01-31C16284748780-11030e365-3cba-111a-e063-dadaa90a10e2Advil IBU Sodium NDC 0573-0133, 0573-0134

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0133-01Advil2 in 1 PACKETTABLET, COATED220
0573-0133-01Advil3000 in 1 CASETABLET, COATED300020
0573-0133-02Advil2 in 1 PACKETTABLET, COATED220
0573-0133-02Advil50 in 1 TRAYTABLET, COATED5020
0573-0133-04Advil2 in 1 BLISTER PACKTABLET, COATED220
0573-0133-04Advil2 in 1 PACKETTABLET, COATED220
0573-0133-05Advil2 in 1 CARTONTABLET, COATED220
0573-0133-05Advil2 in 1 PACKETTABLET, COATED220
0573-0133-20Advil20 in 1 BOTTLETABLET, COATED2020
0573-0133-20Advil1 in 1 CARTONTABLET, COATED120
0573-0133-40Advil1 in 1 CARTONTABLET, COATED120
0573-0133-40Advil40 in 1 BOTTLETABLET, COATED4020
0573-0133-41Advil40 in 1 BOTTLETABLET, COATED4020
0573-0133-41Advil1 in 1 CARTONTABLET, COATED120
0573-0133-80Advil1 in 1 CARTONTABLET, COATED120
0573-0133-80Advil80 in 1 BOTTLETABLET, COATED8020
0573-0133-81Advil100 in 1 BOTTLETABLET, COATED10020
0573-0133-81Advil1 in 1 CARTONTABLET, COATED120
0573-0133-88Advil120 in 1 BOTTLETABLET, COATED12020
0573-0133-88Advil2 in 1 PACKAGETABLET, COATED220
0573-0133-89Advil1 in 1 CARTONTABLET, COATED120
0573-0133-89Advil160 in 1 BOTTLETABLET, COATED16020
0573-0133-91Advil1 in 1 CARTONTABLET, COATED120
0573-0133-91Advil180 in 1 BOTTLETABLET, COATED18020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0133-05EA - Each0573-013317b8a8fd-9081-4699-81a0-61dc7ed5163d12019-06-19
0573-0133-20EA - Each0573-01332dfaeb1d-708e-4b9f-bbec-e46f863f724712019-06-19
0573-0133-40EA - Each0573-013360bda876-b406-4188-bd44-f58fe62dc55912019-06-19
0573-0133-80EA - Each0573-0133cc5678ef-2794-42cc-8b4d-57a120005bb812015-12-02

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
0573-0133ADVIL (IBUPROFEN SODIUM) TABLET, COATED [HALEON US HOLDINGS LLC]19Current NDC, Legacy NDC, 24 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
0573-0133-01005730133013000 PACKET in 1 CASE (0573-0133-01) / 2 TABLET, COATED in 1 PACKET3000 packet2014-08-110000-00-00NoNoCurrent
0573-0133-020057301330250 PACKET in 1 TRAY (0573-0133-02) / 2 TABLET, COATED in 1 PACKET50 packet2013-07-080000-00-00NoNoCurrent
0573-0133-04005730133042 PACKET in 1 BLISTER PACK (0573-0133-04) / 2 TABLET, COATED in 1 PACKET2 packet2013-07-080000-00-00NoNoCurrent
0573-0133-05005730133052 PACKET in 1 CARTON (0573-0133-05) / 2 TABLET, COATED in 1 PACKET2 packet2013-07-080000-00-00NoNoCurrent
0573-0133-20005730133201 BOTTLE in 1 CARTON (0573-0133-20) / 20 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-40005730133401 BOTTLE in 1 CARTON (0573-0133-40) / 40 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-41005730133411 BOTTLE in 1 CARTON (0573-0133-41) / 40 TABLET, COATED in 1 BOTTLE1 bottle2015-08-120000-00-00NoNoCurrent
0573-0133-80005730133801 BOTTLE in 1 CARTON (0573-0133-80) / 80 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-81005730133811 BOTTLE in 1 CARTON (0573-0133-81) / 100 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-88005730133882 BOTTLE in 1 PACKAGE (0573-0133-88) / 120 TABLET, COATED in 1 BOTTLE2 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-89005730133891 BOTTLE in 1 CARTON (0573-0133-89) / 160 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-91005730133911 BOTTLE in 1 CARTON (0573-0133-91) / 180 TABLET, COATED in 1 BOTTLE1 bottle2014-12-010000-00-00NoNoCurrent