FDA.reportPublic FDA data

Application 072300

Type
ANDA
Sponsor
CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL800MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 22 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS IBUPROFENIBUPROFENBetter Living Brands, LLCfab39a0a-882b-bf96-e053-6294a90a29322025-09-02WarningsName fallback
generic name: IBUPROFEN
CHILDRENS IBUPROFENIBUPROFENWALGREEN CO.fea3c4b2-cf96-2425-e053-6394a90ac6972025-09-02WarningsName fallback
generic name: IBUPROFEN
CHILDRENS IBUPROFENIBUPROFEN7-Elevenaf0ec23c-cefc-40a9-ab9a-03b8528d4e132025-09-01WarningsName fallback
generic name: IBUPROFEN
CHILDRENS IBUPROFENIBUPROFENAurohealth LLC0e1bcb06-be48-4efc-82e2-516582e023482025-09-01WarningsName fallback
generic name: IBUPROFEN
CHILDRENS IBUPROFENIBUPROFENKROGER COMPANY15e72384-3a04-242d-e063-6294a90aa0fa2025-09-01WarningsName fallback
generic name: IBUPROFEN
CHILDRENS IBUPROFENIBUPROFEN7-Elevencf7b38fc-0590-126a-e053-2a95a90a3e782025-09-01WarningsName fallback
generic name: IBUPROFEN
CHILDRENS IBUPROFENIBUPROFENChalkboard Healthc63eb5c6-adac-4d23-9661-1081ba4591ba2025-09-01WarningsName fallback
generic name: IBUPROFEN
CHILDRENS IBUPROFENIBUPROFENRandob Labs., Ltd.50d6bf9d-ae37-4af3-bfeb-cc0abf8cb0942025-09-01WarningsName fallback
generic name: IBUPROFEN
CHILDRENS IBUPROFENIBUPROFENAurohealth LLCad55d9b1-17b3-4a17-a4a3-d95ba29439592025-09-01WarningsName fallback
generic name: IBUPROFEN
careone childrens ibuprofenIBUPROFENAmerican Sales Companybf88f91c-70ed-42be-b79c-ec60d4f0acda2025-08-30WarningsName fallback
generic name: IBUPROFEN
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader5975c324-2906-4e71-9b88-2e772d9fbfde2025-08-28WarningsName fallback
generic name: IBUPROFEN
Good Neighbor Pharmacy Childrens IbuprofenIBUPROFENAmerisource Bergenf0a7070b-8acf-49f0-88c8-c841f73242d82025-08-28WarningsName fallback
generic name: IBUPROFEN
foster and thrive ibuprofenIBUPROFENStrategic Sourcing Services LLCcfa8578c-2bcc-4aa7-bb8c-0d0e193020ed2025-08-28WarningsName fallback
generic name: IBUPROFEN
good neighbor pharmacy childrens ibuprofenIBUPROFENAmerisource Bergen7a314b7f-91d6-4196-bd96-2470ff7b0b252025-08-28WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENRite Aid Corporation389454b7-c17d-4413-b1ab-dee9a13f81cf2025-08-25WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
childrens ibuprofenIBUPROFENKroger Company1b78bdeb-efb2-4f5a-af3f-d67d820908472025-08-22WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENPublix Super Markets Incc5cd3843-8d72-4850-bebe-4ac54e4f43fa2025-08-21WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
equate ibuprofenIBUPROFENWal-Mart Stores Incabef43bc-ee9b-4a9c-9cf9-36c3232139092025-08-21WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENBryant Ranch Prepack230fd746-92e0-40b6-9a90-595812bd8a182025-08-20WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
childrens ibuprofenIBUPROFENMeijer Distribution Incd42f9f7c-fe4f-45eb-a455-bffb41295fdc2025-08-20WarningsName fallback
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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