Ibuprofen Tablets, 200 mg

Manufacturer: Polygen Pharmaceuticals LLC | Marksans Pharma Limited
Effective date: 2013-06-27
Label type: Human OTC Drug Label
Version: 6
Source: full-release
Hydrated at: 2026-05-31 22:35:47

Label at a glance#

ProductIbuprofen

Active ingredientIBUPROFEN

Label structure17 sections

Dosage and administration

do not take more than directed the smallest effective dose should be used adults and children 12 years and older: · take 1 tablet every 4 to 6 hours while symptoms persist · if pain or fever does not respond to 1 tablet, 2 tablets may be used · do not exceed 6 tablets 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).

Contacts and useful links#

PhoneLabel contact1-888-291-7337

PhoneFDA MedWatch1-800-FDA-1088

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Use(s)

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pain due to:

backache
headache
menstrual cramps
minor pain of arthritis
muscular aches
the common cold
toothache
temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.

Symptoms may include:

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

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

Stomach bleeding warning: This product contains an NSAID, which may cause 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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
the more or for a longer time 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

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

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

under a doctor’s care for any serious condition
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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 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
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms occur

Side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of 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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
the smallest effective dose should be used

adults and children 12 years and older:	· take 1 tablet every 4 to 6 hours while symptoms persist · if pain or fever does not respond to 1 tablet, 2 tablets may be used · do not exceed 6 tablets in 24 hours unless directed by a doctor
children under 12 years:	ask a doctor

other information

OTHER SAFETY INFORMATION

do not use if seal under cap is broken or missing
see end panel for lot number and expiration date

Inactive ingredient

Inactive ingredient section

colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Storage

STORAGE AND HANDLING SECTION

store between 20-25 °C (68-77 ° F).

Questions

OTC - QUESTIONS SECTION

1-888-291-7337

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTON LABEL PDP

NDC: 52605-114-01

Compare to the active ingredient in Advil^®

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

100 COATED TABLETS

SEE NEW WARNINGS INFORMATION

BOTTLE LABEL PDP

NDC: 52605-114-01

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

100 COATED TABLETS

SEE NEW WARNINGS INFORMATION

ibu200tabbottlab

CARTON LABEL PDP

NDC: 52605-117-01

Compare to the active ingredient in Advil^®

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

100 COATED CAPLETS

SEE NEW WARNINGS INFORMATION

ibucarton100

BOTTLE LABEL PDP

NDC: 52605-117-01

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

100 COATED CAPLETS

SEE NEW WARNINGS INFORMATION

ibubott100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	6
310965	ibuprofen 200 MG Oral Tablet	SCD	6
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	6

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
52605-114-01	2021-01-29	C162847	48780-1	9855d018-dc82-cd31-e053-dbdaa90ab51a	Ibuprofen Tablets, 200 mg
52605-114-10	2021-01-29	C162847	48780-1	9855d018-dc82-cd31-e053-dbdaa90ab51a	Ibuprofen Tablets, 200 mg
52605-117-01	2021-01-29	C162847	48780-1	9855d018-dc82-cd31-e053-dbdaa90ab51a	Ibuprofen Tablets, 200 mg
52605-114-01	2019-11-27	C162847	48780-1	9855d018-dc82-cd31-e053-dbdaa90ab51a	Ibuprofen Tablets, 200 mg
52605-114-10	2019-11-27	C162847	48780-1	9855d018-dc82-cd31-e053-dbdaa90ab51a	Ibuprofen Tablets, 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52605-114-01	Ibuprofen	1 in 1 CARTON	TABLET, COATED	1	6
52605-114-01	Ibuprofen	100 in 1 BOTTLE	TABLET, COATED	100	6
52605-114-10	Ibuprofen	1000 in 1 BOTTLE	TABLET, COATED	1000	6
52605-117-01	Ibuprofen	1 in 1 CARTON	TABLET, COATED	1	6
52605-117-01	Ibuprofen	100 in 1 BOTTLE	TABLET, COATED	100	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52605-114	IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC]	6	Legacy NDC, 3 package rows	20130627_00bc1e01-f90e-444d-b7d6-807797a1d136.zip
52605-117	IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC]	6	Legacy NDC, 2 package rows	20130627_00bc1e01-f90e-444d-b7d6-807797a1d136.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52605-114-10	EA - Each	52605-114	1609c064-1446-472b-a44b-662919ab7948	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	6
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	6
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	6

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Ibuprofen
CROSCARMELLOSE SODIUM
COLLOIDAL SILICON DIOXIDE
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
TALC
TITANIUM DIOXIDE
STARCH, CORN
POLYVINYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52605-117	52605-117-01
52605-114	52605-114-01, 52605-114-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
COLLOIDAL SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
STARCH, CORN	O8232NY3SJ	IACT
POLYVINYL ALCOHOL	532B59J990	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
COLLOIDAL SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
STARCH, CORN	O8232NY3SJ	IACT
POLYVINYL ALCOHOL	532B59J990	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 5 · 273 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	SUSPENSION / AURICULAR (OTIC)	0.05 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, CHEWABLE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL		392 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL		330 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, CHEWABLE / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	IMPLANT / INTRAVITREAL	0.12 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, EXTENDED RELEASE / ORAL		96 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	3.6 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	SUSPENSION/ DROPS / OPHTHALMIC	1.4 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 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
A091239-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-02-01

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	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`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
c265106e-3575-4073-8195-0aa0adb10f45			00bc1e01-f90e-444d-b7d6-807797a1d136	2013-06-27	Warnings	Exact identifier spl id: c265106e-3575-4073-8195-0aa0adb10f45 spl set id: 00bc1e01-f90e-444d-b7d6-807797a1d136

Reported adverse events (FAERS/openFDA)#

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