FDA.reportPublic FDA data

Ibuprofen

Manufacturer
Polygen Pharmaceuticals LLC | Marksans Pharma Limited
Effective date
2013-07-01
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:51

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure15 sections

Dosage and administration

do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings)           adults and children 12 years and older 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...

Storage and handling

Store between 20-25 0 C (68-77 0 F). do not use if seal under bottle cap is broken or missing.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

(each Caplet contains)

Ibuprofen 200 mg (NSAID)*

·        Non-steroidal 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 alerts: 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have bad stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drug containing prescription NSAID (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
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • taken a diuretics
  • reached age 60 or older

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

OTC - ASK DOCTOR/PHARMACIST SECTION

You are

  • taking any other drugs containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attacks 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
  • long term continuous use may increase the risk of heart attack or stroke

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

  • You feel faint, vomit blood, or have bloody or black stools.

        These are signs of stomach bleeding.

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in painful area
  • any new symptoms appear

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 a 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 PoisonControlCenter right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor
    (see Warnings)

         

adults and children 12 years and older
  • 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

STORAGE AND HANDLING SECTION

  • Store between 20-250C (68-770F).
  • do not use if seal under bottle cap is broken or missing.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized starch, talc, Colloidal silicon dioxide, Magnesium stearate,polyvinyl Alcohol, Polyethylene glycol,Titanium dioxide.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label
Thrulife
NDC : 52605-120-01
IBUPROFEN TABLETS, 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED CAPLETS
CAPSULE SHAPED TABLETS

ibu-white-cap-ctnibu-white-cap-ctn




Bottle label PDP
Thrulife
NDC:52605-120-01
IBUPROFEN TABLETS USP, 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED CAPLETS
CAPSULE SHAPED TABLETS

ibu-white-cap-botibu-white-cap-bot





DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN1
310965ibuprofen 200 MG Oral TabletSCD1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52605-120-012020-01-31C16284748780-19d75b9d0-6a12-f424-e053-dadaa90a57cea5e2a7fd-dc7e-4f1b-9436-41b9834caaab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52605-120-01Ibuprofen100 in 1 BOTTLETABLET1001
52605-120-01Ibuprofen1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52605-120IBUPROFEN TABLET [POLYGEN PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20130702_a5e2a7fd-dc7e-4f1b-9436-41b9834caaab.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM1
IBUPROFENACTIVE MOIETYWK2XYI10QM1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9901
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52605-12052605-120-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
IBUPROFENWK2XYI10QMACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
TALC7SEV7J4R1UIACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
COLLOIDAL SILICON DIOXIDEETJ7Z6XBU4IACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POLYVINYL ALCOHOL532B59J990IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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 · 252 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE / ORAL257 mgExact identifier — unii candidate
22 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / BUCCAL16.6 mgExact identifier — unii candidate
22 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48POWDER, FOR SUSPENSION / ORAL11.25 mgExact identifier — unii candidate
22 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FOR SUSPENSION / ORAL1875 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SOLUTION / TOPICAL1.4 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
22 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TROCHE / ORAL50 mgExact identifier — unii candidate
22 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, COATED PELLETS / ORAL198 mgExact identifier — unii candidate
22 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48GRANULE / ORAL150 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING / ORAL1800 mgExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
22 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, EXTENDED RELEASE / ORAL194 mgExact identifier — unii candidate
22 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990IMPLANT / INTRAVITREAL0.12 mgExact identifier — unii candidate
17 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii candidate
28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, EXTENDED RELEASE / ORAL392 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJDROPS / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING / ORAL100 mgExact identifier — unii candidate
22 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, FOR SUSPENSION / ORAL278 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FOR SUSPENSION / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091237-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-02-08

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0884e616aacf4f…
2026-08-18 06:07:402026-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083f01610625f2…
2019-09-15 20:21 UTC2019-09A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08ea99ee380514…
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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
a5e2a7fd-dc7e-4f1b-9436-41b9834caaaba5e2a7fd-dc7e-4f1b-9436-41b9834caaab2013-07-01WarningsExact identifier
spl id: a5e2a7fd-dc7e-4f1b-9436-41b9834caaab
spl set id: a5e2a7fd-dc7e-4f1b-9436-41b9834caaab

Reported adverse events (FAERS/openFDA)#

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