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 58 of 74 · 1,465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
application number: ANDA079205
rxcui: 310964
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
application number: ANDA079205
rxcui: 310964
unii: WK2XYI10QM
IBUPROFEN 200 MGIBUPROFENBasic Drugs, Inc.d3351d44-2078-3adc-e053-2995a90a3c8f2024-01-03WarningsExact identifier
unii: WK2XYI10QM
Discount Drug Mart Eye Drops Multi-Symptom ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEDiscount Drug Mart, Inc.318dc92a-0707-d6a4-e063-6294a90ab78a2024-01-01WarningsExact identifier
unii: B697894SGQ
Harris Teeter Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLHarris Teeter, LLC.31ac6883-ffc6-39de-e063-6294a90a52dd2024-01-01WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Exchange Select High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArmy and Air Force Exchange Service31ac8bd2-c2e9-6f2c-e063-6394a90adc722024-01-01WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
CVS Health Fast Acting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVS Pharmacy, Inc.31addfd2-52f2-05b3-e063-6294a90a337f2024-01-01WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
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

Reported adverse events (FAERS/openFDA)#

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