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 56 of 74 · 1,465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENKROGER COMPANY0fbe42d0-b5f0-0780-e063-6394a90a4ecb2024-04-13WarningsExact identifier
application number: ANDA079205
rxcui: 310964
unii: WK2XYI10QM
dg health ibuprofenIBUPROFENDolgencorp Incb514b589-d965-4a21-91b3-fab4019e9d962024-04-12WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENH E Be00acbc0-352e-4ba1-8433-18a3079f67432024-04-12WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Infants IbuprofenIBUPROFENAurohealth LLC2a48af51-23e2-4fec-a76b-eef1611750f52024-04-10WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADVIL PMDIPHENHYDRAMINE CITRATE AND IBUPROFENHaleon US Holdings LLC658fc201-47c9-6a6d-8af9-6208298d43b42024-04-08WarningsExact identifier
unii: WK2XYI10QM
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENSam's West, Inc74ad11b9-8976-463d-89a3-2b9f5acd0c802024-04-01WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
Dual Action Pain ReliefDUAL ACTION PAIN RELIEFAllegiant Healthfb4fc347-0f90-429f-9ca8-903e736f54962024-03-29WarningsExact identifier
unii: WK2XYI10QM
Advil Liqui-GelsIBUPROFENLil Drug Store Products, Incba5a9a04-993e-4fd6-bb40-6edfdfb69b342024-03-27WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
Infants IbuprofenINFANTS IBUPROFENFamily Dollar Services, Inc.13143eb6-2fe8-487b-e063-6294a90a967e2024-03-27WarningsExact identifier
unii: WK2XYI10QM
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 6DC9Q167V3
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.141b7964-cce6-74e4-e063-6294a90af7462024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Good Sense Dual Action Back PainACETAMINOPHEN, IBUPROFENL. Perrigo Company89476188-cf88-4184-a366-ed4c2e7db1452024-03-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENEXELAN PHARMACEUTICALS, INC.362f934a-4382-43bc-bedd-65081286f1c92024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS746f79aa-3036-1b9b-e053-2a91aa0a1db62024-03-18WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS76f4cc25-a77e-6245-e053-2a91aa0af7ae2024-03-18WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS3ce5b71b-f841-444f-bf66-023e4bd9aa162024-03-15WarningsExact identifier
application number: ANDA079205
rxcui: 310964
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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