FDA.reportPublic FDA data

NDC 59368-397 - 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
59368-397
Package NDCs from labels
59368-397-01
Manufacturer
Praxis, LLC
Effective date
2023-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen - Praxis, LLCPraxis, LLC2023-01-01HUMAN OTC DRUG LABEL

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 52 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENA-S Medication Solutionsfd691a4a-8010-45e6-b3da-b26374792f242024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
unii: WK2XYI10QM
dg health Ibuprofen pmDIPHENHYDRAMINE CITRATE AND IBUPROFENDolgencorp Inc4bbe40de-0957-4705-893d-fcb4191885c92024-01-22WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack6dc47070-4185-404f-94b0-5252a78ea6fe2024-01-18WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepacke4e778f3-97f9-4fd7-8eb8-9ceb5bc9ee7d2024-01-18WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack3762ee9b-5811-46e2-83df-db5f6863e0552024-01-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepacke90c573d-eb0f-45a5-94d1-efdd3d2b7a112024-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
dg health ibuprofenIBUPROFENDolgencorp Inc98492b9f-8f48-42dd-b026-c37dcdc5f8882024-01-08WarningsExact identifier
unii: WK2XYI10QM
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
IBUPROFEN CAIBUPROFENTARGET CORPORATION8e8684fa-095e-c6d6-e053-2a95a90a15b42024-01-03WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENTARGET CORPORATION8e86ae68-7687-79d6-e053-2995a90ac2742024-01-03WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENTARGET CORPORATION8e8646fe-fd62-1662-e053-2a95a90a30082024-01-03WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENTARGET CORPORATION8e872c8d-28e2-cd49-e053-2995a90a469f2024-01-03WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen MiniIBUPROFEN MINI 200 MGTARGET CORPORATIONc80426d9-e121-c24d-e053-2a95a90acf2f2024-01-03WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN 200 MGIBUPROFENBasic Drugs, Inc.d3351d44-2078-3adc-e053-2995a90a3c8f2024-01-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC59f14d2b-f48a-4c25-bea3-3dc9100898b22023-12-31WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen Pain Releiver/ Fever ReducerIBUPROFENAmneal Pharmaceuticals of New York LLCee241be0-35f8-4789-a71f-98de31d6a5902023-12-31WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen (NSAID) Pain Releiver/ Fever ReducerIBUPROFENAmneal Pharmaceuticals of New York LLCa8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad02023-12-31WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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