FDA.reportPublic FDA data

NDC 68210-0200-01 - IBUPROFEN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68210-0200
Requested NDC
68210-0200-01
Package NDCs from labels
68210-0200-1, 68210-0200-01
Manufacturer
SPIRIT PHARMACEUTICALS,LLC
Effective date
2024-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IBUPROFEN - SPIRIT PHARMACEUTICALS,LLCSPIRIT PHARMACEUTICALS,LLC2024-12-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0200-1IBUPROFEN10 in 1 BOTTLECAPSULE, LIQUID FILLED108
68210-0200-1IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0200IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]8Current NDC, Legacy NDC, 2 package rows20250101_2810122e-3c89-49a2-8dac-db3714cb7b45.zip

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 59 of 74 · 1,465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen (NSAID) Pain Releiver/ Fever ReducerIBUPROFENAmneal Pharmaceuticals of New York LLCa8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad02023-12-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals NY LLCe07d989d-1b0e-4cc1-abf2-93c8b208a29a2023-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral SuspensionIBUPROFENDEMOULAS SUPERMARKETS INC.4ca54293-9e81-4b24-8112-734f28cd2c552023-12-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBionpharma Inc.4bc6e8f2-ba95-4352-80ed-b44608fc49362023-12-27WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
Dye-Free IbuprofenIBUPROFENRITE AID CORPORATIONc1c58a2d-9ffd-69d0-e053-2a95a90a57182023-12-27WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWALGREEN COMPANY3a193fdb-ab6e-464e-9f13-fda0fa8d50a82023-12-27WarningsExact identifier
unii: WK2XYI10QM
Equate Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Wal-Mart Stores, Inc.91fb8fb5-b871-4535-e053-2995a90a9b162023-12-23WarningsExact identifier
unii: B697894SGQ
Sunmark Eye Drops Advanced Moisturizer/LubricantDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINEStrategic Sourcing Services LLC0daa4e39-0447-44b6-a7d7-370b12bf94512023-12-23WarningsExact identifier
unii: B697894SGQ
Equate Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWal-Mart Stores, Inc.91f85a72-5270-e4db-e053-2995a90aeb212023-12-23WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWal-Mart Stores, Inc.e32233ef-ea15-45b8-8e83-b658cf4c56a02023-12-23WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Sunmark Lubricant Eye DropsPOLYPROPYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCb117ff0a-1a48-4022-96e6-52bc45f056fc2023-12-23WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Sunmark Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC043ccc34-44ee-416a-88bc-f247774e90752023-12-23WarningsExact identifier
unii: B697894SGQ
Sunmark Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC58f0b6d7-6072-40fd-ba72-b3ed688347912023-12-23WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Rite Aid Corporationfa1b5b66-9643-e9a7-e053-6394a90ae3cf2023-12-23WarningsExact identifier
unii: B697894SGQ
Signature Care Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands, LLC05a63929-fccd-2936-e063-6294a90aeac52023-12-23WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Meijer Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.9feadde4-fbe5-0c9e-e053-2995a90a9b302023-12-22WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Meijer Ultra Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.a0846e3e-687c-fd55-e053-2995a90a673e2023-12-22WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Meijer Advanced Redness and Irritation ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea6d7a-a2cd-d26e-e053-2995a90a15f82023-12-22WarningsExact identifier
unii: B697894SGQ
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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