Ibuprofen

Manufacturer: L.N.K. International, Inc. | LNK International, Inc.
Effective date: 2026-01-12
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: full-release
Hydrated at: 2026-06-01 01:32:47

Label at a glance#

ProductIbuprofen

Active ingredientIBUPROFEN

Label structure9 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

store between 20°-25°C (68°-77°F) avoid excessive heat 40°C (104°F) use by expiration date on package

Contacts and useful links#

PhoneLabel contact1-800-426-9391

Label contents#

Full prescribing information#

Active ingredient (in each brown caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen USP, 200 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:
- headache
- toothache
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
temporarily reduces fever

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)
skin reddening
shock
rash
blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

stomach bleeding warning applies to you
you have problems or serious side effects from taking pain relievers or fever reducers
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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

you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
you have symptoms of heart problems or stroke:
- chest pain
- weakness in one part or side of body
- leg swelling
- slurred speech
- trouble breathing
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
any new symptoms appear
redness or swelling is present in the painful area

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

store between 20°-25°C (68°-77°F)
avoid excessive heat 40°C (104°F)
use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality
+Plus

NDC 50844-292-16

^†Compare to active ingredient
in Advil® Caplets

IBUPROFEN TABLETS
USP, 200 mg

PAIN RELIEVER/
FEVER REDUCER (NSAID)

1000 Coated Caplets**
**CAPSULE-SHAPED TABLETS

ACTUAL
SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING

^†This product is not manufactured or distributed by PF Consumer
Healthcare 1 LLC, owner of the registered trademark Advil® Caplets.
50844 REV1221C29216

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	13
310965	ibuprofen 200 MG Oral Tablet	SCD	13
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	13

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0050844292161	GTIN-13: 0050844292161 EAN-13: 0050844292161 GTIN-12: 050844292161 UPC-A: 050844292161 GTIN storage (14 digits): 00050844292161	quality-plus-44-292-1.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50844-292-00	Ibuprofen	250 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	250	13
50844-292-01	Ibuprofen	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	13
50844-292-01	Ibuprofen	1 in 1 CARTON	TABLET, FILM COATED	1	13
50844-292-02	Ibuprofen	1 in 1 CARTON	TABLET, FILM COATED	1	13
50844-292-02	Ibuprofen	12 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	12	13
50844-292-08	Ibuprofen	24 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	24	13
50844-292-08	Ibuprofen	1 in 1 CARTON	TABLET, FILM COATED	1	13
50844-292-11	Ibuprofen	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	13
50844-292-11	Ibuprofen	1 in 1 CARTON	TABLET, FILM COATED	1	13
50844-292-12	Ibuprofen	1 in 1 CARTON	TABLET, FILM COATED	1	13
50844-292-12	Ibuprofen	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	13
50844-292-13	Ibuprofen	1 in 1 CARTON	TABLET, FILM COATED	1	13
50844-292-13	Ibuprofen	250 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	250	13
50844-292-14	Ibuprofen	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	13
50844-292-15	Ibuprofen	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	13
50844-292-15	Ibuprofen	1 in 1 CARTON	TABLET, FILM COATED	1	13
50844-292-16	Ibuprofen	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	1
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	1
Carnauba Wax	INACTIVE INGREDIENT	R12CBM0EIZ	1
Hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	1
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	1
Polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	1
Polyethylene Glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

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

Ibuprofen
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE RED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50844-292	50844-292-02, 50844-292-08, 50844-292-01, 50844-292-15, 50844-292-11, 50844-292-12, 50844-292-00, 50844-292-13, 50844-292-14, 50844-292-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 2 · 88 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Hypromellose	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, FILM COATED / ORAL		18 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, FILM COATED / ORAL		18 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Hypromellose	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, FILM COATED / ORAL		18 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, FILM COATED / ORAL		18 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Hypromellose	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Hypromellose	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Hypromellose	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Hypromellose	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, FILM COATED / ORAL		18 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii+route+dosage form 11 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
A075010-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1999-03-01

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	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`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
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c	2026-01-12	Warnings	Exact identifier ndc (package): 50844-292-02 ndc (package): 50844-292-15 ndc (package): 50844-292-08 ndc (package): 50844-292-13 ndc (package): 50844-292-01 ndc (package): 50844-292-11 ndc (package): 50844-292-16 ndc (package): 50844-292-12 ndc (package): 50844-292-14 ndc (package): 50844-292-00 ndc (product): 50844-292 ndc11 (package): 50844029211 ndc11 (package): 50844029200 ndc11 (package): 50844029216 ndc11 (package): 50844029208 ndc11 (package): 50844029202 ndc11 (package): 50844029215 ndc11 (package): 50844029214 ndc11 (package): 50844029201 ndc11 (package): 50844029213 ndc11 (package): 50844029212 spl id: 310ac7c5-2530-4013-9f56-934a58054bd1 spl set id: d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c

Reported adverse events (FAERS/openFDA)#

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