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ADVIL

ibuprofen · Tablet, Coated

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
Generic name
ibuprofen
Dosage form
Tablet, Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Haleon US Holdings LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
16
Packages
76
Data completeness
82% 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
Ibuprofen Sodium 256 mg/1 153008 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
92

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
018989
Application type
NDA · New Drug Application
Approval date
May 18, 1984
Sponsor
HALEON US HOLDINGS
Products on application
1
Submissions recorded
60
Products approved under application 018989.
Product Trade name Form Strength Ingredient Status TE Flags
018989-001 ADVIL TABLET 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 018989.
Type No. Action Status Date Review
Supplement 104 Labeling Approved December 30, 2024 Standard
Supplement 99 Labeling Approved December 14, 2021 Standard
Supplement 95 Manufacturing (CMC) Approved April 10, 2020 N/A
Supplement 91 Labeling Approved November 14, 2018 Standard
Supplement 90 Labeling Approved October 2, 2018 Standard
Supplement 88 Labeling Approved August 23, 2017 Standard
Supplement 87 Manufacturing (CMC) Approved February 3, 2017 Standard
Supplement 85 Manufacturing (CMC) Approved April 29, 2016 Priority
Supplement 84 Manufacturing (CMC) Approved December 16, 2015 Priority
Supplement 83 Manufacturing (CMC) Approved May 18, 2015 Priority
Supplement 79 Labeling Approved April 26, 2011 Unknown
Supplement 80 Labeling Approved September 1, 2010 Unknown
Supplement 73 Labeling Approved May 19, 2009 Standard
Supplement 70 Labeling Approved June 11, 2008 Standard
Supplement 67 Labeling Approved May 1, 2007 Standard
Supplement 60 Labeling Approved April 17, 2006 Standard
Supplement 61 Labeling Approved April 4, 2006 Standard
Supplement 58 Labeling Approved July 16, 2004 Standard
Supplement 56 Manufacturing (CMC) Approved September 26, 2003 Priority
Supplement 55 Manufacturing (CMC) Approved April 24, 2002 Priority
Supplement 53 Manufacturing (CMC) Approved September 7, 2001 Priority
Supplement 54 Manufacturing (CMC) Approved August 2, 2001 Priority
Supplement 52 Labeling Approved November 15, 2000 Standard
Supplement 50 Manufacturing (CMC) Approved November 19, 1999 Priority
Supplement 51 Manufacturing (CMC) Approved October 4, 1999 Priority
Supplement 49 Manufacturing (CMC) Approved October 14, 1998 Priority
Supplement 46 Manufacturing (CMC) Approved April 3, 1997 Priority
Supplement 48 Manufacturing (CMC) Approved December 19, 1996 Priority
Supplement 47 Manufacturing (CMC) Approved December 3, 1996 Priority
Supplement 43 Manufacturing (CMC) Approved August 1, 1995 Priority
Supplement 42 Manufacturing (CMC) Approved April 4, 1995 Priority
Supplement 40 Manufacturing (CMC) Approved October 24, 1994 Priority
Supplement 41 Manufacturing (CMC) Approved September 7, 1994 Priority
Supplement 37 Labeling Approved March 11, 1994 —
Supplement 36 Labeling Approved March 11, 1994 —
Supplement 39 Manufacturing (CMC) Approved October 18, 1993 Priority
Supplement 38 Manufacturing (CMC) Approved October 18, 1993 Priority
Supplement 33 Manufacturing (CMC) Approved February 26, 1993 Priority
Supplement 31 Manufacturing (CMC) Approved April 25, 1991 Priority
Supplement 28 Manufacturing (CMC) Approved April 25, 1991 Priority
Supplement 34 Manufacturing (CMC) Approved August 24, 1990 Priority
Supplement 30 Manufacturing (CMC) Approved June 28, 1989 Priority
Supplement 29 Manufacturing (CMC) Approved February 14, 1989 Priority
Supplement 26 Manufacturing (CMC) Approved May 25, 1988 Priority
Supplement 25 Manufacturing (CMC) Approved May 25, 1988 Priority
Supplement 23 Manufacturing (CMC) Approved May 25, 1988 Priority
Supplement 18 Manufacturing (CMC) Approved May 25, 1988 Priority
Supplement 16 Manufacturing (CMC) Approved May 25, 1988 Priority
Supplement 27 Manufacturing (CMC) Approved May 2, 1988 Priority
Supplement 17 Manufacturing (CMC) Approved February 1, 1988 Priority
Supplement 21 Manufacturing (CMC) Approved January 17, 1987 Priority
Supplement 22 Manufacturing (CMC) Approved January 6, 1987 Priority
Supplement 15 Labeling Approved July 5, 1986 —
Supplement 10 Manufacturing (CMC) Approved May 30, 1986 Priority
Supplement 14 Manufacturing (CMC) Approved December 24, 1985 Priority
Supplement 6 Manufacturing (CMC) Approved October 19, 1985 Priority
Supplement 5 Manufacturing (CMC) Approved September 17, 1985 Priority
Supplement 4 Manufacturing (CMC) Approved December 18, 1984 Priority
Supplement 7 Manufacturing (CMC) Approved October 5, 1984 Priority
Original application 1 Type 3 - New Dosage Form Approved May 18, 1984 Priority

Review documents

  • 0 · Supplement · March 24, 2025
  • 0 · Supplement · January 2, 2025
  • 0 · Supplement · December 16, 2021
  • 0 · Supplement · December 16, 2021
  • 0 · Supplement · November 23, 2018
  • 0 · Supplement · November 16, 2018
  • 0 · Supplement · October 15, 2018
  • 0 · Supplement · October 11, 2018
  • 0 · Supplement · August 30, 2017
  • 0 · Supplement · August 29, 2017
  • 0 · Supplement · December 22, 2015
  • 0 · Supplement · December 18, 2015
  • 0 · Supplement · March 27, 2012
  • 0 · Supplement · April 28, 2011
  • 0 · Supplement · September 7, 2010
  • 0 · Supplement · May 26, 2009
  • 0 · Supplement · June 13, 2008
  • 0 · Supplement · May 7, 2007
  • 0 · Supplement · May 7, 2007
  • 0 · Supplement · April 20, 2006
  • 0 · Supplement · April 7, 2006
  • 0 · Supplement · July 21, 2004
  • 0 · Supplement · May 26, 2004
  • 0 · Supplement · May 26, 2004
  • 0 · Supplement · September 30, 2003
  • 0 · Supplement · September 30, 2003
  • 0 · Supplement · April 23, 2003

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260408). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260408 HUMAN OTC DRUG · 20260312 HUMAN OTC DRUG · 20251003 HUMAN OTC DRUG · 20240717

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Pain reliever/ Fever reducer

Dosage and Administration

openFDA Drug Labeling

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

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

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

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

Warnings

openFDA Drug Labeling

Warnings Section 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 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

openFDA Drug Labeling

Do not use • if you have ever had an allergic reaction to any other pain reliever or 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

openFDA Drug Labeling

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 Advil Tablets (in each tablet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug Advil Caplets (in each caplet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug Advil Gel Caplets (in each gel caplet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Advil Tablets (in each tablet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Advil Caplets (in each caplet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Advil Gel Caplets (in each gel caplet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

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
0573-0133-01 0573-0133 Haleon US Holdings LLC 3000 PACKET in 1 CASE (0573-0133-01) / 2 TABLET, COATED in 1 PACKET August 11, 2014
0573-0133-02 0573-0133 Haleon US Holdings LLC 50 PACKET in 1 TRAY (0573-0133-02) / 2 TABLET, COATED in 1 PACKET July 8, 2013
0573-0133-04 0573-0133 Haleon US Holdings LLC 2 PACKET in 1 BLISTER PACK (0573-0133-04) / 2 TABLET, COATED in 1 PACKET July 8, 2013
0573-0133-05 0573-0133 Haleon US Holdings LLC 2 PACKET in 1 CARTON (0573-0133-05) / 2 TABLET, COATED in 1 PACKET July 8, 2013
0573-0133-20 0573-0133 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0133-20) / 20 TABLET, COATED in 1 BOTTLE July 8, 2013
0573-0133-40 0573-0133 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0133-40) / 40 TABLET, COATED in 1 BOTTLE July 8, 2013
0573-0133-41 0573-0133 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0133-41) / 40 TABLET, COATED in 1 BOTTLE August 12, 2015
0573-0133-80 0573-0133 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0133-80) / 80 TABLET, COATED in 1 BOTTLE July 8, 2013
0573-0133-81 0573-0133 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0133-81) / 100 TABLET, COATED in 1 BOTTLE July 8, 2013
0573-0133-88 0573-0133 Haleon US Holdings LLC 2 BOTTLE in 1 PACKAGE (0573-0133-88) / 120 TABLET, COATED in 1 BOTTLE July 8, 2013
0573-0133-89 0573-0133 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0133-89) / 160 TABLET, COATED in 1 BOTTLE July 8, 2013
0573-0133-91 0573-0133 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0133-91) / 180 TABLET, COATED in 1 BOTTLE December 1, 2014
0573-0134-20 0573-0134 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0134-20) / 20 TABLET, COATED in 1 BOTTLE July 8, 2013
0573-0134-80 0573-0134 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0134-80) / 80 TABLET, COATED in 1 BOTTLE July 8, 2013
0573-0150-20 0573-0150 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0150-20) / 24 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0150-30 0573-0150 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0150-30) / 50 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0150-31 0573-0150 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0150-31) / 75 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0150-32 0573-0150 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0150-32) / 60 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0150-40 0573-0150 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0150-40) / 100 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0150-41 0573-0150 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0150-41) / 125 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0150-42 0573-0150 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0150-42) / 150 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0151-05 0573-0151 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0151-05) / 115 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0151-10 0573-0151 Haleon US Holdings LLC 10 VIAL in 1 PACKAGE (0573-0151-10) / 10 TABLET, COATED in 1 VIAL May 18, 1984
0573-0151-12 0573-0151 Haleon US Holdings LLC 10 TABLET, COATED in 1 VIAL (0573-0151-12) May 18, 1984
0573-0151-13 0573-0151 Haleon US Holdings LLC 3 VIAL in 1 PACKAGE (0573-0151-13) / 10 TABLET, COATED in 1 VIAL May 18, 1984
0573-0151-20 0573-0151 Haleon US Holdings LLC 2 VIAL in 1 PACKAGE (0573-0151-20) / 10 TABLET, COATED in 1 VIAL May 18, 1984
0573-0151-21 0573-0151 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0151-21) / 36 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0151-30 0573-0151 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0151-30) / 130 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0151-40 0573-0151 Haleon US Holdings LLC 2 BOTTLE in 1 CARTON (0573-0151-40) / 100 TABLET, COATED in 1 BOTTLE March 28, 2025
0573-0151-48 0573-0151 Haleon US Holdings LLC 2 CARTON in 1 PACKAGE (0573-0151-48) / 1 BOTTLE in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0154-16 0573-0154 Haleon US Holdings LLC 3 POUCH in 1 CARTON (0573-0154-16) / 2 TABLET, COATED in 1 POUCH May 18, 1984
0573-0154-17 0573-0154 Haleon US Holdings LLC 3000 POUCH in 1 CASE (0573-0154-17) / 2 TABLET, COATED in 1 POUCH May 18, 1984
0573-0154-21 0573-0154 Haleon US Holdings LLC 200 TABLET, COATED in 1 BOTTLE (0573-0154-21) January 4, 2016
0573-0154-35 0573-0154 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0154-35) / 150 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0154-59 0573-0154 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0154-59) / 200 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0154-60 0573-0154 Haleon US Holdings LLC 360 TABLET, COATED in 1 BOTTLE (0573-0154-60) May 18, 1984
0573-0154-75 0573-0154 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0154-75) / 200 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0154-84 0573-0154 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0154-84) / 225 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0154-89 0573-0154 Haleon US Holdings LLC 50 POUCH in 1 CASE (0573-0154-89) / 2 TABLET, COATED in 1 POUCH May 18, 1984
0573-0154-98 0573-0154 Haleon US Holdings LLC 300 TABLET, COATED in 1 BOTTLE (0573-0154-98) May 18, 1984
0573-0160-17 0573-0160 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0160-17) / 115 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0160-20 0573-0160 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0160-20) / 24 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0160-25 0573-0160 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0160-25) / 36 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0160-30 0573-0160 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0160-30) / 50 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0160-31 0573-0160 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0160-31) / 75 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0160-40 0573-0160 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0160-40) / 100 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0160-41 0573-0160 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0160-41) / 125 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0160-42 0573-0160 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0160-42) / 150 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0161-35 0573-0161 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0161-35) / 150 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0161-51 0573-0161 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0161-51) / 200 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0161-65 0573-0161 Haleon US Holdings LLC 65 TABLET, COATED in 1 BOTTLE (0573-0161-65) May 1, 2017
0573-0161-85 0573-0161 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0161-85) / 225 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0165-20 0573-0165 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0165-20) / 24 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0165-25 0573-0165 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0165-25) / 36 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0165-30 0573-0165 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0165-30) / 50 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0165-31 0573-0165 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0165-31) / 75 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0165-40 0573-0165 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0165-40) / 100 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0165-41 0573-0165 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0165-41) / 125 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0165-42 0573-0165 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0165-42) / 150 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0166-51 0573-0166 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0166-51) / 200 TABLET, COATED in 1 BOTTLE May 18, 1984
0573-0166-85 0573-0166 Haleon US Holdings LLC 225 TABLET, COATED in 1 BOTTLE (0573-0166-85) May 18, 1984
0573-1711-14 0573-1711 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-1711-14) / 225 TABLET, COATED in 1 BOTTLE May 18, 1984
66715-5803-0 66715-5803 Lil' Drug Store Products, Inc. 30 POUCH in 1 BOX, UNIT-DOSE (66715-5803-0) / 2 TABLET, COATED in 1 POUCH November 16, 2006
66715-6434-2 66715-6434 Lil' Drug Store Products, Inc. 2 POUCH in 1 CARTON (66715-6434-2) / 2 TABLET, COATED in 1 POUCH November 29, 2022
66715-6500-2 66715-6500 Lil' Drug Store Products, Inc. 2 POUCH in 1 CARTON (66715-6500-2) / 2 TABLET, COATED in 1 POUCH May 6, 2022
66715-9700-2 66715-9700 Lil' Drug Store Products, Inc. 2 POUCH in 1 CARTON (66715-9700-2) / 2 TABLET, COATED in 1 POUCH December 15, 2018
66715-9700-3 66715-9700 Lil' Drug Store Products, Inc. 3 POUCH in 1 CARTON (66715-9700-3) / 2 TABLET, COATED in 1 POUCH December 15, 2018
66715-9700-7 66715-9700 Lil' Drug Store Products, Inc. 30 POUCH in 1 BOX, UNIT-DOSE (66715-9700-7) / 2 TABLET, COATED in 1 POUCH April 19, 2022
67751-146-01 67751-146 Navajo Manufacturing Company Inc. 1 POUCH in 1 CARTON (67751-146-01) / 2 TABLET, COATED in 1 POUCH September 20, 2016
67751-146-02 67751-146 Navajo Manufacturing Company Inc. 2 POUCH in 1 CARTON (67751-146-02) / 2 TABLET, COATED in 1 POUCH September 20, 2016
67751-146-06 67751-146 Navajo Manufacturing Company Inc. 3 POUCH in 1 CARTON (67751-146-06) / 2 TABLET, COATED in 1 POUCH April 21, 2025
85237-1786-1 85237-1786 Select Consumer Group 1 POUCH in 1 BLISTER PACK (85237-1786-1) / 1 TABLET, COATED in 1 POUCH May 18, 1984
85237-1786-2 85237-1786 Select Consumer Group 2 POUCH in 1 BLISTER PACK (85237-1786-2) / 2 TABLET, COATED in 1 POUCH (85237-1786-0) May 18, 1984
85237-1786-4 85237-1786 Select Consumer Group 25 POUCH in 1 BOX (85237-1786-4) / 2 TABLET, COATED in 1 POUCH (85237-1786-0) May 18, 1984
85237-1786-6 85237-1786 Select Consumer Group 50 POUCH in 1 BOX (85237-1786-6) / 2 TABLET, COATED in 1 POUCH (85237-1786-0) May 18, 1984
85237-1786-7 85237-1786 Select Consumer Group 3 POUCH in 1 BLISTER PACK (85237-1786-7) / 2 TABLET, COATED in 1 POUCH (85237-1786-0) May 18, 1984
0573-0133 0573-0133 Haleon US Holdings LLC — July 8, 2013
0573-0134 0573-0134 Haleon US Holdings LLC — July 8, 2013
0573-0150 0573-0150 Haleon US Holdings LLC — May 18, 1984
0573-0151 0573-0151 Haleon US Holdings LLC — May 18, 1984
0573-0154 0573-0154 Haleon US Holdings LLC — May 18, 1984
0573-0160 0573-0160 Haleon US Holdings LLC — May 18, 1984
0573-0161 0573-0161 Haleon US Holdings LLC — May 18, 1984
0573-0165 0573-0165 Haleon US Holdings LLC — May 18, 1984
0573-0166 0573-0166 Haleon US Holdings LLC — May 18, 1984
0573-1711 0573-1711 Haleon US Holdings LLC — May 18, 1984
66715-5803 66715-5803 Lil' Drug Store Products, Inc. — November 16, 2006
66715-6434 66715-6434 Lil' Drug Store Products, Inc. — November 29, 2022
66715-6500 66715-6500 Lil' Drug Store Products, Inc. — May 6, 2022
66715-9700 66715-9700 Lil' Drug Store Products, Inc. — February 22, 2010
67751-146 67751-146 Navajo Manufacturing Company Inc. — September 20, 2016
85237-1786 85237-1786 Select Consumer Group — May 18, 1984

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 · 12 sections on this page.