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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201803-001ADVILIBUPROFEN SODIUMEQ 200MG BASETABLET / ORALRLD, RS2012-06-12

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdvilIBUPROFEN SODIUMHaleon US Holdings LLC5be198b8-396e-4b44-8819-e2e3b5d2ad0e2025-10-03WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to ...

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#

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