FDA.reportPublic FDA data

Application 071267

Type
ANDA
Sponsor
CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL400MGNoNo

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 20 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENRite Aid Corporation1dba3cb7-2e3d-4378-93cf-92db8f24f41f2025-10-09WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
RIGHT REMEDIES Ibuprofen 200 MGIBUPROFENStrive Pharmaceuticals Inc.5c155210-d16f-487e-983d-c7b0f97365c62025-10-08WarningsName fallback
generic name: IBUPROFEN
Childrens MotrinIBUPROFENKenvue Brands LLC63ec7636-bf2a-4d52-ab88-fb93d41661ec2025-10-08WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC6521bc47-4d9c-4a5b-b109-3841f3be4b6c2025-10-07WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens MotrinIBUPROFENKenvue Brands LLC15b0b56d-6188-4937-b541-902022e35b242025-10-07WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INCbfda6547-19b2-4230-87a1-a68fbec740b42025-10-06WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Motrin IBIBUPROFENKenvue Brands LLCd21129f8-4d96-4e36-bc39-a534306dd77e2025-10-03WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPHOENIX RX LLC40202c76-4275-88fd-e063-6394a90a07b22025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
careone ibuprofenIBUPROFENAmerican Sales Company2720b8aa-4361-4cd4-be26-aa6dd1692d122025-10-01WarningsName fallback
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.a1a5a9c7-c727-4e41-a8f0-2982f796a3ca2025-09-29WarningsName fallback
generic name: IBUPROFEN
leader ibuprofenIBUPROFENCardinal Health 110, LLC. dba Leader96da60f7-06a9-438a-ae59-8609fdd1587d2025-09-25WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENKroger Companybc173f1b-2e44-2c2e-e053-2a95a90a89c42025-09-24WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IBUPROFENIBUPROFENKroger Companybbedfc37-913d-8046-e053-2995a90af68a2025-09-24WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
pain reliefIBUPROFENMeijer, Inc.ae39917e-1998-4298-8686-919c0d3c2b072025-09-19WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepack7acdd557-0b6c-48f5-9437-7bc567af1f852025-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension Dye FreeIBUPROFENFSA Store Inc. (Caring Mill)099e374b-49c2-4d56-a047-d4f0c4af34ba2025-09-18WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.06710aef-2631-4925-8e9e-33bae84b59122025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepack86fc38bc-7f54-4aab-9c4d-d0898a4381f92025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepackd50f829d-071f-4299-9b74-0f28caac71182025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENMeijer Distribution Ince28e64dc-5f4e-4260-953a-3de38a5eaa762025-09-15WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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