Childrens MOTRIN

Manufacturer: Kenvue Brands LLC
Effective date: 2024-11-01
Label type: HUMAN OTC DRUG LABEL
Version: 16
Source: full-release
Hydrated at: 2026-06-01 00:33:32

Label at a glance#

ProductChildrens MOTRIN

Active ingredientIBUPROFEN

Label structure10 sections

Indications and uses

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

Dosage and administration

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 resist...

Storage and handling

each 5 mL contains: sodium 2 mg store between 20-25°C (68-77°F) do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-895-3665

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 100 mg (NSAID) ¹

1 nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

under a doctor's care for any serious condition
taking any other drug

When using this product

OTC - WHEN USING SECTION

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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)

Directions

DOSAGE & ADMINISTRATION SECTION

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) ^*
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

* or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

each 5 mL contains: sodium 2 mg
store between 20-25°C (68-77°F)
do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-601-22

For Ages 2 to 11 Years

Children's
Motrin ^®

contains Ibuprofen

Oral Suspension (NSAID)

100 mg per 5 mL

Pain Reliever / Fever Reducer

Lasts up to
8 hours

Alcohol Free

Original
Berry Flavor

1 fl oz (30 mL)

Motrin-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	16
544393	Motrin Children 100 MG in 5 mL Oral Suspension	PSN	16
544393	ibuprofen 20 MG/ML Oral Suspension [Motrin]	SBD	16
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	16
544393	Children's Motrin 100 MG per 5 ML Oral Suspension	SY	16
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	16
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	16
544393	Motrin 20 MG/ML Oral Suspension	SY	16

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
IBUPROFEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50580-601-08	2024-02-06	C162847	48780-1	1030e364-fb10-111a-e063-dadaa90a10e2	Children's MOTRIN
50580-601-20	2024-02-06	C162847	48780-1	1030e364-fb10-111a-e063-dadaa90a10e2	Children's MOTRIN
50580-601-21	2024-02-06	C162847	48780-1	1030e364-fb10-111a-e063-dadaa90a10e2	Children's MOTRIN
50580-601-22	2024-02-06	C162847	48780-1	1030e364-fb10-111a-e063-dadaa90a10e2	Children's MOTRIN
50580-601-25	2024-02-06	C162847	48780-1	1030e364-fb10-111a-e063-dadaa90a10e2	Children's MOTRIN
50580-601-08	2024-01-30	C162847	48780-1	1030e364-fb10-111a-e063-dadaa90a10e2	Children's MOTRIN
50580-601-20	2024-01-30	C162847	48780-1	1030e364-fb10-111a-e063-dadaa90a10e2	Children's MOTRIN
50580-601-21	2024-01-30	C162847	48780-1	1030e364-fb10-111a-e063-dadaa90a10e2	Children's MOTRIN
50580-601-22	2024-01-30	C162847	48780-1	1030e364-fb10-111a-e063-dadaa90a10e2	Children's MOTRIN
50580-601-25	2024-01-30	C162847	48780-1	1030e364-fb10-111a-e063-dadaa90a10e2	Children's MOTRIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-601-04	Childrens MOTRIN	120 mL in 1 BOTTLE, PLASTIC	SUSPENSION	120	16
50580-601-04	Childrens MOTRIN	1 in 1 CARTON	SUSPENSION	1	16
50580-601-08	Childrens MOTRIN	2 in 1 PACKAGE	SUSPENSION	2	16
50580-601-20	Childrens MOTRIN	1 in 1 CARTON	SUSPENSION	1	16
50580-601-20	Childrens MOTRIN	120 mL in 1 BOTTLE, PLASTIC	SUSPENSION	120	16
50580-601-21	Childrens MOTRIN	1 in 1 CARTON	SUSPENSION	1	16
50580-601-21	Childrens MOTRIN	120 mL in 1 BOTTLE, PLASTIC	SUSPENSION	120	16
50580-601-22	Childrens MOTRIN	30 mL in 1 BOTTLE, PLASTIC	SUSPENSION	30	16
50580-601-22	Childrens MOTRIN	1 in 1 CARTON	SUSPENSION	1	16
50580-601-25	Childrens MOTRIN	2 in 1 PACKAGE	SUSPENSION	2	16
50580-601-25	Childrens MOTRIN	1 in 1 CARTON	SUSPENSION	1	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-601	CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [KENVUE BRANDS LLC]	16	Current NDC, Legacy NDC, 11 package rows	20241103_f2609308-17bf-4bcb-84b2-d17f3fd35958.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-601-02	ML - Milliliter	50580-601	42731c07-20ff-472c-8853-3f36b0bfceef	1	2012-07-24
50580-601-04	ML - Milliliter	50580-601	cf7d0d9a-3bb6-48e5-b268-751d68acde51	1	2012-07-24
50580-601-08	ML - Milliliter	50580-601	15da2c10-1fbc-41d3-8de3-74f24d8e33a1	1	2012-07-24
50580-601-20	ML - Milliliter	50580-601	f2880dc1-37a2-4bfb-bf72-d9956f8f76c3	1	2012-07-24
50580-601-21	ML - Milliliter	50580-601	477aaf3e-399a-4e4d-baae-7b3694b88bb0	1	2013-03-03
50580-601-22	ML - Milliliter	50580-601	6cfb1465-d497-40d2-8252-f05ba72a9fd3	1	2016-06-14
50580-601-50	ML - Milliliter	50580-601	983ed4a0-bf23-439a-a289-734fe98b01e5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	3
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	3
acesulfame potassium	INACTIVE INGREDIENT	23OV73Q5G9	3
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	3
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	3
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	3
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	3
sucrose	INACTIVE INGREDIENT	C151H8M554	3
water	INACTIVE INGREDIENT	059QF0KO0R	3
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Childrens MOTRIN
Ibuprofen
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C RED NO. 40
GLYCERIN
POLYSORBATE 80
WATER
SODIUM BENZOATE
SUCROSE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-601	50580-601-04, 50580-601-08, 50580-601-21, 50580-601-22, 50580-601-20, 50580-601-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCROSE	C151H8M554	IACT
XANTHAN GUM	TTV12P4NEE	IACT
IBUPROFEN	WK2XYI10QM	ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 63 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020516-001	CHILDREN'S MOTRIN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		RLD, RS	1995-06-16
N020516-002	MOTRIN IB	IBUPROFEN	200MG/10ML	SUSPENSION / ORAL		RLD, RS	2026-07-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020516-002	MOTRIN IB	200MG/10ML	SUSPENSION / ORAL	RLD, RS	2026-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020516-002	MOTRIN IB	200MG/10ML	SUSPENSION / ORAL	RLD, RS	2026-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`3bdfa0b2c4d7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens MOTRIN	IBUPROFEN	Kenvue Brands LLC	f2609308-17bf-4bcb-84b2-d17f3fd35958	2024-11-01	Warnings	Exact identifier ndc (package): 50580-601-20 ndc (package): 50580-601-22 ndc (package): 50580-601-08 ndc (package): 50580-601-04 ndc (package): 50580-601-25 ndc (package): 50580-601-21 ndc (product): 50580-601 ndc11 (package): 50580060104 ndc11 (package): 50580060122 ndc11 (package): 50580060120 ndc11 (package): 50580060121 ndc11 (package): 50580060108 ndc11 (package): 50580060125 spl id: 22ebcf8b-8b39-47f7-e063-6394a90a735b spl set id: f2609308-17bf-4bcb-84b2-d17f3fd35958

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.