Ibuprofen Oral Suspension, USP

Manufacturer: Chain Drug Consortium, LLC | Teva Pharmaceuticals USA, Inc.
Effective date: 2019-05-29
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-02 00:23:20

Label at a glance#

ProductChildrens Ibuprofen

Active ingredientIBUPROFEN

Label structure18 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 find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed measuring cup 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 (tsp ...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-432-8534

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL = 1 teaspoon)
Ibuprofen, USP 100 mg (NSAID)**
**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: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
shock
asthma (wheezing)
rash
skin reddening
blisters
facial swelling

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

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:

OTC - DO NOT USE SECTION

if the child has ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

ASK 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, or kidney disease
child has asthma
child is taking a diuretic

ASK 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
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
the child does not get any relief within the 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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
find right dose on chart. If possible, use weight to dose; otherwise use age.
use only enclosed measuring cup
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 (tsp or mL)
under 2 years		ask a doctor
24-35 lbs	2-3 years	1 tsp or 5 mL
36-47 lbs	4-5 years	1 ½ tsp or 7.5 mL
48-59 lbs	6-8 years	2 tsp or 10 mL
60-71 lbs	9-10 years	2 ½ tsp or 12.5 mL
72-95 lbs	11 years	3 tsp or 15 mL

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

each teaspoon contains: sodium 2 mg
do not use if printed neckband is broken or missing
store between 20 - 25°C (68 - 77°F)
see bottom panel for lot number and expiration date

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

Dye free berry flavor: citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

Grape flavor: citric acid, D&C red #33, FD&C blue #1, FD&C red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

QUESTIONS?

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Package Label - Original Berry Flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68016-255-94

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S MOTRIN^®BERRY^*

Premier Value^®

For Ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)

Pain Reliever
Fever Reducer

Lasts up to 8 hours

Shake Well
Before Using

Original Berry Flavor
Alcohol Free
4 fl oz (118 mL)

original berry label

Package Label - Dye-Free Berry Flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68016-261-94

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S MOTRIN^® DYE FREE BERRY^*

Premier Value^®

For Ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)

Pain Reliever
Fever Reducer

Lasts up to 8 hours

Shake Well
Before Using

Non- staining
Dye free Berry Flavor
Alcohol Free
4 fl oz (118 mL)

Package Label - Grape Flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68016-262-94

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S MOTRIN^® GRAPE^*

Premier Value^®

For Ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)

Pain Reliever
Fever Reducer

Lasts up to 8 hours

Shake Well
Before Using

Grape Flavor
Alcohol Free
4 fl oz (118 mL)

Package Label - Bupple Gum Flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68016-263-94

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S MOTRIN^® BUBBLE GUM^*

Premier Value^®

For Ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)

Pain Reliever
Fever Reducer

Lasts up to 8 hours

Shake Well
Before Using

Bubble Gum Flavor
Alcohol Free
4 fl oz (118 mL)

bubble gum flavor

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-255-94	ML - Milliliter	68016-255	8d0f4826-f059-458e-8832-7ce91b898062	1	2013-03-03
68016-261-94	ML - Milliliter	68016-261	1476a278-2dbe-49d5-849c-7530758031c6	1	2022-06-06
68016-262-94	ML - Milliliter	68016-262	36e392cb-5c17-45b6-9d71-870638a05155	1	2013-03-03
68016-263-94	ML - Milliliter	68016-263	7dda13cb-4824-40a4-b2aa-16b4cc94e82d	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	4
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	4

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Childrens Ibuprofen
Ibuprofen
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C RED NO. 40
GLYCERIN
HYPROMELLOSE 2910 (4000 MPA.S)
POLYSORBATE 80
WATER
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
ALCOHOL
D&C RED NO. 33
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68016-255	68016-255-94
68016-261	68016-261-94
68016-262	68016-262-94
68016-263	68016-263-94

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCROSE	C151H8M554	IACT
XANTHAN GUM	TTV12P4NEE	IACT
ALCOHOL	3K9958V90M	CNTM
IBUPROFEN	WK2XYI10QM	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCROSE	C151H8M554	IACT
XANTHAN GUM	TTV12P4NEE	IACT
ALCOHOL	3K9958V90M	CNTM
IBUPROFEN	WK2XYI10QM	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCROSE	C151H8M554	IACT
XANTHAN GUM	TTV12P4NEE	IACT
ALCOHOL	3K9958V90M	CNTM
IBUPROFEN	WK2XYI10QM	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	IACT

Source Document#

Source XML

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 9 · 490 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM / SUBLINGUAL	0.07 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		34 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	DOUCHE / VAGINAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVITREAL	0.02 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		38 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / RECTAL	0.01 %w/v		Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUPPOSITORY / RECTAL	0.11 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	INSERT / VAGINAL	54.21 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 37 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074916-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1999-04-30

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`f41ea6bd6efb…`

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
a791abe3-2bec-46b4-9447-4b6b75001e37			12460e7d-b8e8-499e-8abe-e1aeb996898e	2019-05-29	Warnings	Exact identifier spl id: a791abe3-2bec-46b4-9447-4b6b75001e37 spl set id: 12460e7d-b8e8-499e-8abe-e1aeb996898e

Reported adverse events (FAERS/openFDA)#

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