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Childrens Motrin

Ibuprofen · Suspension

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
Childrens Motrin
Generic name
Ibuprofen
Dosage form
Suspension
Route
Oral
Marketing category
NDA · NDA
Labeler
Kenvue Brands LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
10
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 100 mg/5mL 310965 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Suspension
Route of administration
Oral
Presentations
14

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
020516
Application type
NDA · New Drug Application
Approval date
June 16, 1995
Sponsor
KENVUE BRANDS
Products on application
2
Submissions recorded
28
Products approved under application 020516.
Product Trade name Form Strength Ingredient Status TE Flags
020516-001 CHILDREN'S MOTRIN SUSPENSION IBUPROFEN Over-the-counter — RLD RS
020516-002 MOTRIN IB SUSPENSION 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 020516.
Type No. Action Status Date Review
Supplement 45 Labeling Approved July 22, 2026 Standard
Supplement 38 Manufacturing (CMC) Approved February 19, 2021 N/A
Supplement 36 Labeling Approved November 29, 2018 Standard
Supplement 35 Labeling Approved March 14, 2017 Standard
Supplement 34 Manufacturing (CMC) Approved January 9, 2017 Standard
Supplement 32 Manufacturing (CMC) Approved June 17, 2016 Standard
Supplement 33 Labeling Approved June 16, 2016 Standard
Supplement 31 Manufacturing (CMC) Approved December 7, 2015 Standard
Supplement 30 Labeling Approved April 16, 2015 Standard
Supplement 29 Labeling Approved December 11, 2014 Standard
Supplement 28 Manufacturing (CMC) Approved November 19, 2012 Standard
Supplement 26 Manufacturing (CMC) Approved August 12, 2012 Standard
Supplement 24 Labeling Approved December 6, 2011 Standard
Supplement 22 Labeling Approved October 19, 2010 Unknown
Supplement 21 Labeling Approved April 29, 2009 Standard
Supplement 20 Manufacturing (CMC) Approved June 22, 2006 N/A
Supplement 18 Labeling Approved December 7, 2005 Standard
Supplement 16 Manufacturing (CMC) Approved February 7, 2005 Standard
Supplement 12 Labeling Approved December 19, 2003 Standard
Supplement 11 Labeling Approved October 28, 2003 Standard
Supplement 8 Manufacturing (CMC) Approved May 2, 2001 Standard
Supplement 6 Labeling Approved October 2, 2000 Standard
Supplement 7 Manufacturing (CMC) Approved July 18, 2000 Standard
Supplement 4 Labeling Approved September 13, 1999 Standard
Supplement 3 Manufacturing (CMC) Approved December 18, 1998 Standard
Supplement 2 Labeling Approved June 4, 1998 Standard
Supplement 1 Labeling Approved March 31, 1997 Standard
Original application 1 Type 8 - Partial Rx to OTC Switch Approved June 16, 1995 Standard

Review documents

  • 0 · Supplement · July 24, 2026
  • 0 · Supplement · July 24, 2026
  • 0 · Supplement · June 30, 2021
  • 0 · Supplement · June 16, 2021
  • 0 · Supplement · December 19, 2018
  • 0 · Supplement · December 3, 2018
  • 0 · Supplement · March 20, 2017
  • 0 · Supplement · March 16, 2017
  • 0 · Supplement · June 22, 2016
  • 0 · Supplement · June 21, 2016
  • 0 · Supplement · April 21, 2015
  • 0 · Supplement · April 17, 2015
  • 0 · Supplement · December 19, 2014
  • 0 · Supplement · December 12, 2014
  • 0 · Supplement · December 8, 2011
  • 0 · Supplement · October 22, 2010
  • 0 · Supplement · May 6, 2009
  • 0 · Supplement · June 28, 2006
  • 0 · Supplement · December 15, 2005
  • 0 · Supplement · February 9, 2005
  • 0 · Supplement · December 23, 2003
  • 0 · Supplement · October 31, 2003
  • 0 · Supplement · September 13, 1999
  • 0 · Supplement · September 13, 1999
  • 0 · Supplement · September 13, 1999

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241101). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20241101

Indications and Usage

openFDA Drug Labeling

Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

Purpose

openFDA Drug Labeling

Purpose Pain reliever/fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dosing cup. Do not use any other dosing device. if needed, repeat dose every 6-8 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL

Warnings

openFDA Drug Labeling

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 your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes 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. Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do Not Use

openFDA Drug Labeling

Do not use if the child has ever had an allergic reaction to ibuprofen or 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 your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has asthma child is taking a diuretic

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling the child does not get any relief within first day (24 hours) of treatment fever or pain 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 5 mL) Ibuprofen 100 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
50580-184-01 50580-184 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (50580-184-01) / 240 mL in 1 BOTTLE, PLASTIC December 27, 2021
50580-184-50 50580-184 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (50580-184-50) / 120 mL in 1 BOTTLE, PLASTIC February 28, 2012
50580-184-52 50580-184 Kenvue Brands LLC 3 CARTON in 1 PACKAGE (50580-184-52) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC May 3, 2021
50580-601-08 50580-601 Kenvue Brands LLC 2 CARTON in 1 PACKAGE (50580-601-08) / 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-04) / 120 mL in 1 BOTTLE, PLASTIC January 30, 2002
50580-601-20 50580-601 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-20) / 120 mL in 1 BOTTLE, PLASTIC March 1, 2012
50580-601-21 50580-601 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-21) / 120 mL in 1 BOTTLE, PLASTIC March 1, 2012
50580-601-22 50580-601 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-22) / 30 mL in 1 BOTTLE, PLASTIC March 1, 2012
50580-601-25 50580-601 Kenvue Brands LLC 2 CARTON in 1 PACKAGE (50580-601-25) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC July 10, 2012
50580-603-04 50580-603 Kenvue Brands LLC 1 BOTTLE in 1 CARTON (50580-603-04) / 120 mL in 1 BOTTLE January 25, 2016
50580-604-04 50580-604 Kenvue Brands LLC 1 BOTTLE in 1 CARTON (50580-604-04) / 120 mL in 1 BOTTLE January 25, 2016
50580-184 50580-184 Kenvue Brands LLC — September 1, 2001
50580-601 50580-601 Kenvue Brands LLC — September 1, 1995
50580-603 50580-603 Kenvue Brands LLC — January 25, 2016
50580-604 50580-604 Kenvue Brands LLC — January 25, 2016

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.