Perrigo Junior Strength Ibuprofen Tablets, 100 mg Drug Facts

Manufacturer: Dispensing Solutions, Inc. | PSS World Medical, Inc.
Effective date: 2013-11-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:37:22

Label at a glance#

ProductGood Sense ibuprofen

Active ingredientIBUPROFEN

Label structure9 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than directed find the right dose on chart below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24-35 2-3 1 36-47 4-5 1 ½ 48-59 6-8 2 60-71 9-10 2 ½ 72-95 11 3

Storage and handling

phenylketonurics: contains phenylalanine 6 mg per tablet do not use if printed seal under cap is broken or missing store at 20-25°C (68-77°F) see end panel for lot number and expiration date

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

Warnings

WARNINGS SECTION

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

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 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, or kidney disease
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

mouth or throat burning may occur; give with food or water
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
find the right dose on chart below. If possible, use weight to dose; otherwise use age.
if needed, repeat dose every 6-8 hours
do not use more than 4 times a day

Dosing Chart
Weight (lb)	Age (yr)	Tablets
under 24	under 2	ask a doctor
24-35	2-3	1
36-47	4-5	1 ½
48-59	6-8	2
60-71	9-10	2 ½
72-95	11	3

Other information

STORAGE AND HANDLING SECTION

phenylketonurics: contains phenylalanine 6 mg per tablet
do not use if printed seal under cap is broken or missing
store at 20-25°C (68-77°F)
see end panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, ammonium glycerrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For Ages 2 to 11

See New Warnings Information

Junior Strength Ibuprofen Tablets, 100 mg

Lasts Up To 8 Hours

Pain Reliever / Fever Reducer (NSAID)

Orange Flavor

Compare to active ingredient of Motrin® Junior Strength

NDC 68258-2994-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310963	ibuprofen 100 MG Chewable Tablet	PSN	1
310963	ibuprofen 100 MG Chewable Tablet	SCD	1

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
68258-2994-2	2019-11-27	C162847	48780-1	9855e2a2-38ca-60a7-e053-dbdaa90a05bd	Perrigo Junior Strength Ibuprofen Tablets, 100 mg Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-2994-2	Good Sense ibuprofen	24 in 1 BOTTLE	TABLET, CHEWABLE	24		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-2994	GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 1 package rows	20131107_56cb55bf-3fd8-4613-bc45-73e53204dc97.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68258-2994-2	EA - Each	68258-2994	e4fdb6bf-92dd-4e18-b2d0-8de78678678e	1	2013-12-02
0113-0461-62	EA - Each	0113-0461	6bc8fb2a-5f41-426c-b851-72dd02d3a995	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	1
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	1
SUCCINIC ACID	INACTIVE INGREDIENT	AB6MNQ6J6L	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Good Sense ibuprofen
Ibuprofen
ASPARTAME
CARNAUBA WAX
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SOYBEAN OIL
SUCCINIC ACID
ACESULFAME POTASSIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68258-2994	68258-2994-2
0113-0461

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
ASPARTAME	Z0H242BBR1	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SOYBEAN OIL	241ATL177A	IACT
SUCCINIC ACID	AB6MNQ6J6L	IACT
ACESULFAME POTASSIUM	23OV73Q5G9	IACT

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 6 · 342 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, DELAYED RELEASE / ORAL		79 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	GRANULE, FOR SUSPENSION / ORAL		282 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FOR SUSPENSION / ORAL		264 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER / ORAL		4352 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / INTRAMUSCULAR	6.75 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / INTRAVENOUS		15200 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	200 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
SUCCINIC ACID	SUCCINIC ACID	AB6MNQ6J6L	CONCENTRATE / ORAL		60 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, DELAYED RELEASE PARTICLES / ORAL		64 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED PELLETS / ORAL		14 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SUCCINIC ACID	SUCCINIC ACID	AB6MNQ6J6L	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		3 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SYRUP / ORAL		250 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		543 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, DELAYED RELEASE / ORAL	0.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / TOPICAL	4 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, ORALLY DISINTEGRATING / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, EFFERVESCENT / ORAL		4 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	4.35 %w/w		Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	LOTION / TOPICAL		111 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION / ORAL	705 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SYRUP / ORAL	4 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SOLUTION / ORAL		40 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL		3391 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SUSPENSION / ORAL		23 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, DELAYED RELEASE / ORAL		280 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / RECTAL	0.5 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE / ORAL		1488 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	980.4 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION, EXTENDED RELEASE / ORAL	2464.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, EXTENDED RELEASE / ORAL		2150 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	DROPS / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 34 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
A076359-001	IBUPROFEN	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL			2004-01-16
A076359-002	IBUPROFEN	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL		RS	2004-01-16

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 3 · 86 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	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`74a2ff9319b5…`

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
a601000f-dbf5-4d7b-b1d2-72bfb36db5ea			56cb55bf-3fd8-4613-bc45-73e53204dc97	2013-11-06	Warnings	Exact identifier spl id: a601000f-dbf5-4d7b-b1d2-72bfb36db5ea spl set id: 56cb55bf-3fd8-4613-bc45-73e53204dc97

Reported adverse events (FAERS/openFDA)#

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