Home NDC 0573-0133 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201803-001 ADVIL IBUPROFEN SODIUM EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Advil IBUPROFEN SODIUM Haleon US Holdings LLC 5be198b8-396e-4b44-8819-e2e3b5d2ad0e 2025-10-03 Warnings Exact 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 Ingredient Strength IBUPROFEN SODIUM 256 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii RM1CE97Z4N Rxcui 153008, 310965
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 0573-0133-01 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134 0573-0133-02 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134 0573-0133-04 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134 0573-0133-05 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134 0573-0133-20 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134 0573-0133-40 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134 0573-0133-41 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134 0573-0133-80 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134 0573-0133-81 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134 0573-0133-88 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134 0573-0133-89 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134 0573-0133-91 2024-01-31 C162847 48780-1 1030e365-3cba-111a-e063-dadaa90a10e2 Advil IBU Sodium NDC 0573-0133, 0573-0134
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0573-0133-01 Advil 2 in 1 PACKET TABLET, COATED 2 20 0573-0133-01 Advil 3000 in 1 CASE TABLET, COATED 3000 20 0573-0133-02 Advil 2 in 1 PACKET TABLET, COATED 2 20 0573-0133-02 Advil 50 in 1 TRAY TABLET, COATED 50 20 0573-0133-04 Advil 2 in 1 BLISTER PACK TABLET, COATED 2 20 0573-0133-04 Advil 2 in 1 PACKET TABLET, COATED 2 20 0573-0133-05 Advil 2 in 1 CARTON TABLET, COATED 2 20 0573-0133-05 Advil 2 in 1 PACKET TABLET, COATED 2 20 0573-0133-20 Advil 20 in 1 BOTTLE TABLET, COATED 20 20 0573-0133-20 Advil 1 in 1 CARTON TABLET, COATED 1 20 0573-0133-40 Advil 1 in 1 CARTON TABLET, COATED 1 20 0573-0133-40 Advil 40 in 1 BOTTLE TABLET, COATED 40 20 0573-0133-41 Advil 40 in 1 BOTTLE TABLET, COATED 40 20 0573-0133-41 Advil 1 in 1 CARTON TABLET, COATED 1 20 0573-0133-80 Advil 1 in 1 CARTON TABLET, COATED 1 20 0573-0133-80 Advil 80 in 1 BOTTLE TABLET, COATED 80 20 0573-0133-81 Advil 100 in 1 BOTTLE TABLET, COATED 100 20 0573-0133-81 Advil 1 in 1 CARTON TABLET, COATED 1 20 0573-0133-88 Advil 120 in 1 BOTTLE TABLET, COATED 120 20 0573-0133-88 Advil 2 in 1 PACKAGE TABLET, COATED 2 20 0573-0133-89 Advil 1 in 1 CARTON TABLET, COATED 1 20 0573-0133-89 Advil 160 in 1 BOTTLE TABLET, COATED 160 20 0573-0133-91 Advil 1 in 1 CARTON TABLET, COATED 1 20 0573-0133-91 Advil 180 in 1 BOTTLE TABLET, COATED 180 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN SODIUM ACTIVE INGREDIENT RM1CE97Z4N ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 IBUPROFEN ACTIVE MOIETY WK2XYI10QM ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0573-0133 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [HALEON US HOLDINGS LLC] 19 Current NDC, Legacy NDC, 24 package rows 20240625_5be198b8-396e-4b44-8819-e2e3b5d2ad0e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0573-0133-01 00573013301 3000 PACKET in 1 CASE (0573-0133-01) / 2 TABLET, COATED in 1 PACKET 3000 packet 2014-08-11 0000-00-00 No No Current 0573-0133-02 00573013302 50 PACKET in 1 TRAY (0573-0133-02) / 2 TABLET, COATED in 1 PACKET 50 packet 2013-07-08 0000-00-00 No No Current 0573-0133-04 00573013304 2 PACKET in 1 BLISTER PACK (0573-0133-04) / 2 TABLET, COATED in 1 PACKET 2 packet 2013-07-08 0000-00-00 No No Current 0573-0133-05 00573013305 2 PACKET in 1 CARTON (0573-0133-05) / 2 TABLET, COATED in 1 PACKET 2 packet 2013-07-08 0000-00-00 No No Current 0573-0133-20 00573013320 1 BOTTLE in 1 CARTON (0573-0133-20) / 20 TABLET, COATED in 1 BOTTLE 1 bottle 2013-07-08 0000-00-00 No No Current 0573-0133-40 00573013340 1 BOTTLE in 1 CARTON (0573-0133-40) / 40 TABLET, COATED in 1 BOTTLE 1 bottle 2013-07-08 0000-00-00 No No Current 0573-0133-41 00573013341 1 BOTTLE in 1 CARTON (0573-0133-41) / 40 TABLET, COATED in 1 BOTTLE 1 bottle 2015-08-12 0000-00-00 No No Current 0573-0133-80 00573013380 1 BOTTLE in 1 CARTON (0573-0133-80) / 80 TABLET, COATED in 1 BOTTLE 1 bottle 2013-07-08 0000-00-00 No No Current 0573-0133-81 00573013381 1 BOTTLE in 1 CARTON (0573-0133-81) / 100 TABLET, COATED in 1 BOTTLE 1 bottle 2013-07-08 0000-00-00 No No Current 0573-0133-88 00573013388 2 BOTTLE in 1 PACKAGE (0573-0133-88) / 120 TABLET, COATED in 1 BOTTLE 2 bottle 2013-07-08 0000-00-00 No No Current 0573-0133-89 00573013389 1 BOTTLE in 1 CARTON (0573-0133-89) / 160 TABLET, COATED in 1 BOTTLE 1 bottle 2013-07-08 0000-00-00 No No Current 0573-0133-91 00573013391 1 BOTTLE in 1 CARTON (0573-0133-91) / 180 TABLET, COATED in 1 BOTTLE 1 bottle 2014-12-01 0000-00-00 No No Current