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Advil Liqui-Gels

Ibuprofen · Capsule, Liquid Filled

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Advil Liqui-Gels
Generic name
Ibuprofen
Dosage form
Capsule, Liquid Filled
Route
Oral
Marketing category
NDA · NDA
Labeler
Lil Drug Store Products, Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
5
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ibuprofen 200 mg/1 310965 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Liquid Filled
Route of administration
Oral
Presentations
9

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-Inflammatory Agents EPC All 251 members
Cyclooxygenase Inhibitors [MoA] MoA All 251 members
Non-Steroidal [CS] CS All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC] EPC All 251 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020402
Application type
NDA · New Drug Application
Approval date
April 20, 1995
Sponsor
HALEON US HOLDINGS
Products on application
2
Submissions recorded
27
Products approved under application 020402.
Product Trade name Form Strength Ingredient Status TE Flags
020402-001 ADVIL LIQUI-GELS CAPSULE IBUPROFEN Over-the-counter — RLD RS
020402-002 ADVIL MIGRAINE LIQUI-GELS CAPSULE IBUPROFEN Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020402.
Type No. Action Status Date Review
Supplement 58 Labeling Approved January 8, 2025 Standard
Supplement 55 Labeling Approved February 23, 2023 Standard
Supplement 53 Labeling Approved January 25, 2022 Standard
Supplement 47 Labeling Approved August 31, 2018 Standard
Supplement 46 Labeling Approved August 2, 2018 Standard
Supplement 44 Manufacturing (CMC) Approved October 18, 2017 Standard
Supplement 43 Labeling Approved August 8, 2017 Standard
Supplement 42 Manufacturing (CMC) Approved March 8, 2017 N/A
Supplement 40 Manufacturing (CMC) Approved December 17, 2015 Standard
Supplement 39 Manufacturing (CMC) Approved September 12, 2014 Standard
Supplement 37 Manufacturing (CMC) Approved December 11, 2012 Standard
Supplement 36 Manufacturing (CMC) Approved December 5, 2012 Standard
Supplement 27 Labeling Approved April 20, 2011 Standard
Supplement 26 Manufacturing (CMC) Approved July 9, 2009 N/A
Supplement 25 Labeling Approved May 19, 2009 Standard
Supplement 24 Labeling Approved June 11, 2008 Standard
Supplement 16 Labeling Approved April 28, 2006 Standard
Supplement 18 Labeling Approved February 8, 2006 Standard
Supplement 11 Labeling Approved February 26, 2004 Standard
Supplement 7 Manufacturing (CMC) Approved August 2, 2001 Standard
Supplement 6 Manufacturing (CMC) Approved March 28, 2000 Standard
Supplement 5 Efficacy Approved March 16, 2000 Standard
Supplement 4 Manufacturing (CMC) Approved April 9, 1999 Standard
Supplement 3 Manufacturing (CMC) Approved February 5, 1999 Standard
Supplement 2 Labeling Approved February 23, 1998 Standard
Supplement 1 Manufacturing (CMC) Approved October 6, 1997 Standard
Original application 1 Type 3 - New Dosage Form Approved April 20, 1995 Standard

Review documents

  • 0 · Supplement · September 23, 2025
  • 0 · Supplement · January 10, 2025
  • 0 · Supplement · February 24, 2023
  • 0 · Supplement · February 24, 2023
  • 0 · Supplement · February 3, 2022
  • 0 · Supplement · September 14, 2018
  • 0 · Supplement · September 13, 2018
  • 0 · Supplement · August 3, 2018
  • 0 · Supplement · August 3, 2018
  • 0 · Supplement · October 19, 2017
  • 0 · Supplement · August 15, 2017
  • 0 · Supplement · August 15, 2017
  • 0 · Supplement · August 1, 2017
  • 0 · Supplement · August 1, 2017
  • 0 · Supplement · December 22, 2015
  • 0 · Supplement · December 18, 2015
  • 0 · Supplement · July 9, 2015
  • 0 · Supplement · April 22, 2011
  • 0 · Supplement · July 15, 2009
  • 0 · Supplement · May 26, 2009
  • 0 · Supplement · June 17, 2008
  • 0 · Supplement · May 2, 2006
  • 0 · Supplement · February 22, 2006
  • 0 · Supplement · February 27, 2004
  • 0 · Supplement · July 8, 2003
  • 0 · Supplement · March 16, 2000
  • 0 · Supplement · March 16, 2000

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240327). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240327

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Purpose Pain reliever/Fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

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 during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

openFDA Drug Labeling

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

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

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each capsule) Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID) nonsteroidal anti-inflammatory drug (present as the free acid and potassium salt)

Adverse event reports

Source: openFDA FAERS
283,546
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
66715-6452-2 66715-6452 Lil Drug Store Products, Inc 2 POUCH in 1 CARTON (66715-6452-2) / 2 CAPSULE, LIQUID FILLED in 1 POUCH November 14, 2022
66715-6552-2 66715-6552 Lil Drug Store Products, Inc 2 POUCH in 1 CARTON (66715-6552-2) / 2 CAPSULE, LIQUID FILLED in 1 POUCH May 6, 2022
66715-9752-2 66715-9752 Lil Drug Store Products, Inc 2 POUCH in 1 CARTON (66715-9752-2) / 2 CAPSULE, LIQUID FILLED in 1 POUCH October 23, 2017
66715-9752-3 66715-9752 Lil Drug Store Products, Inc 3 POUCH in 1 CARTON (66715-9752-3) / 2 CAPSULE, LIQUID FILLED in 1 POUCH December 7, 2020
29485-6552-4 29485-6552 Lil' Drug Store Products, Inc. 2 POUCH in 1 CARTON (29485-6552-4) / 2 CAPSULE, LIQUID FILLED in 1 POUCH August 25, 2017
66715-6452 66715-6452 Lil Drug Store Products, Inc — October 23, 2017
66715-6552 66715-6552 Lil Drug Store Products, Inc — October 23, 2017
66715-9752 66715-9752 Lil Drug Store Products, Inc — October 23, 2017
29485-6552 29485-6552 Lil' Drug Store Products, Inc. — August 25, 2017

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.