FDA.reportPublic FDA data

ibuprofen

Manufacturer
Contract Pharmacal Corp.
Effective date
2018-11-07
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-05-31 22:57:18

Label at a glance#

Productibuprofen
Active ingredientIBUPROFEN
Label structure18 sections

Indications and uses

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

Dosage and administration

do not take more than directed the smallest effective dose should be used Adults and children 12 years of age and over: ■ 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 of age: ■ Ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Important: Read all product information before using.
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Drug Facts

ACTIVE INGREDIENT (in each tablet)

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
  • muscular ache
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • 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)
  • 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 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
  • take more or for longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increases 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 ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery

ASK DOCTOR before use if

OTC - ASK DOCTOR SECTION

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • the stomach bleeding warning applies to you
  • 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 and 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
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • 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 appear

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 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 (1-800-222-1222) right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

Adults and children 12 years of age and over:

■ 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 of age: ■ Ask a doctor

SPL UNCLASSIFIED SECTION

Other information

  • store between 20˚ to 25˚C (68˚to 77˚F)
  • avoid excessive heat above 40˚C (104˚F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

(White) Carnauba Wax, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

(Orange) Croscarmellose Sodium, FD&C Yellow #6 Lake, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc and Titanium Dioxide.

(Brown) Croscarmellose Sodium, Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Red Iron Oxide, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

QUESTIONS or COMMENTS?

OTC - QUESTIONS SECTION

Call 1-800-231-4670: weekdays 9:00 AM to 5:00 PM EST

SPL UNCLASSIFIED SECTION

**This product is not manufactured or distributed by McNeil, owner of the registered trademark Motrin®IB

Manufactured by:

Contract Pharmacal Corp.

135 Adams Avenue

Hauppauge, NY 11788 USA

www.cpc.com

XXXXX-10-18

Barcode

Peel here for more information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See New Warnings

CONTRACT PHARMACAL CORP NDC 10267-3909-2

**Compares to the active ingredient in Motrin ®IB


GLUTEN FREE

Ibuprofen Tablets, USP 200 mg

Pain Reliever/Fever Reducer

(NSAID)

250 Coated Tablets

DYE-FREE

NOT ACTUAL SIZE

Ibuprofen white label 3909Ibuprofen white label 3909

See New Warnings


CONTRACT PHARMACAL CORP NDC 10267-3846-2

**Compares to the active ingredient in Motrin ®IB

GLUTEN FREE

Ibuprofen Tablets, USP 200 mg

Pain Reliever/Fever Reducer

(NSAID)

250 Coated Tablets

NOT ACTUAL SIZE

Ibuprofen Orange label 3846Ibuprofen Orange label 3846

See New Warnings


CONTRACT PHARMACAL CORP NDC 10267-3852-2

**Compares to the active ingredient in Motrin ®IB

GLUTEN FREE

Ibuprofen Tablets, USP 200 mg

Pain Reliever/Fever Reducer

(NSAID)

250 Coated Tablets

NOT ACTUAL SIZE

Ibuprofen Brown labelIbuprofen Brown label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN13
310965ibuprofen 200 MG Oral TabletSCD13
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY13

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10267-3846-2ibuprofen250 in 1 BOTTLETABLET25013
10267-3852-2ibuprofen250 in 1 BOTTLETABLET25013
10267-3909-2ibuprofen250 in 1 BOTTLETABLET25013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10267-3846IBUPROFEN TABLET [CONTRACT PHARMACAL CORP.]13Current NDC, Legacy NDC, 1 package rows20181120_237bcb87-64a0-415b-bd53-e9d3b8bf33b6.zip
10267-3852IBUPROFEN TABLET [CONTRACT PHARMACAL CORP.]13Current NDC, Legacy NDC, 1 package rows20181120_237bcb87-64a0-415b-bd53-e9d3b8bf33b6.zip
10267-3909IBUPROFEN TABLET [CONTRACT PHARMACAL CORP.]13Current NDC, Legacy NDC, 1 package rows20181120_237bcb87-64a0-415b-bd53-e9d3b8bf33b6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM5
IBUPROFENACTIVE MOIETYWK2XYI10QM5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH485
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A85
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6755
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671P5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9905
POVIDONE K30INACTIVE INGREDIENTU725QWY32X5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU45
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6B5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP5
TALCINACTIVE INGREDIENT7SEV7J4R1U5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP5

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10267-385210267-3852-2
10267-384610267-3846-2
10267-390910267-3909-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STARCH, CORNO8232NY3SJIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
POVIDONE K30U725QWY32XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FERRIC OXIDE RED1K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPROMELLOSES3NXW29V3WOIACT
IBUPROFENWK2XYI10QMACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STARCH, CORNO8232NY3SJIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
POVIDONE K30U725QWY32XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYVINYL ALCOHOL532B59J990IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
IBUPROFENWK2XYI10QMACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STARCH, CORNO8232NY3SJIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
POVIDONE K30U725QWY32XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYSORBATE 806OZP39ZG8HIACT
CARNAUBA WAXR12CBM0EIZIACT
IBUPROFENWK2XYI10QMACTIB

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 2 · 90 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET / ORAL230 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / ORAL2828 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / ORAL2828 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET / ORAL230 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / ORAL2828 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET / ORAL230 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET / ORAL230 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
6 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071265-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1986-10-15
A071265-002IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-09-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-1584e616aacf4f…
2026-09-14 22:38:342026-08A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-1084e616aacf4f…
2026-08-18 06:07:402026-07A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-15caaa826d4ba7…
2026-08-18 06:07:402026-07A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071265-001IBUPROFEN200MGTABLET / ORAL1986-10-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071265-002IBUPROFEN200MGTABLET / ORAL1987-09-1074a2ff9319b5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENContract Pharmacal Corp.237bcb87-64a0-415b-bd53-e9d3b8bf33b62018-11-07WarningsExact identifier
ndc (package): 10267-3852-2
ndc (package): 10267-3909-2
ndc (package): 10267-3846-2
ndc (product): 10267-3909
ndc (product): 10267-3852
ndc (product): 10267-3846
ndc11 (package): 10267385202
ndc11 (package): 10267384602
ndc11 (package): 10267390902
spl id: 77cf0092-7436-14ba-e053-2991aa0ac112
spl set id: 237bcb87-64a0-415b-bd53-e9d3b8bf33b6

Reported adverse events (FAERS/openFDA)#

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