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 46 of 74 · 1,476 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Code Red Eye Drops Redness ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL4 Trees, LLC0aa08018-cc2d-d947-e063-6394a90a914a2025-02-07WarningsExact identifier
unii: B697894SGQ
Ibuprofen infants DropsIBUPROFENHarris Teeter, LLC2c39a24f-4e42-d75f-e063-6394a90a60fa2025-02-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.fae53f7b-3948-2566-e053-6394a90aae362025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENHarris Teeter, LLC2bb186c8-f791-5f1f-e063-6294a90a87ff2025-02-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.0bee69ff-cf76-175e-e063-6294a90a42f62025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC2cf7412a-7f94-e39f-e063-6294a90a5bc22025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd2457c045-0b7c-48f4-9422-11623f13d8f12025-01-29WarningsExact identifier
unii: WK2XYI10QM
AdvilIBUPROFENLil' Drug Store Products, Inc.772360bd-8631-4d24-b4db-5a7e6e1d9a132025-01-27WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltdefb728f2-fe74-4833-8f0c-710d833abf6e2025-01-27WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENDirect Rxd88d0544-57a7-4a82-e053-2a95a90a19452025-01-21Exact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral Suspension, Dye FreeIBUPROFENBest Choice55fd05c7-b902-4c82-ab9a-8054d880dfbd2025-01-20WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENDIRECT RXc3f30813-0848-6e8a-e053-2995a90a3dea2025-01-20Exact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral Suspension, Bubble GumIBUPROFENBest Choiced27ca801-d4d3-4fd0-a22b-db5ada5fcb9f2025-01-20WarningsExact identifier
unii: WK2XYI10QM
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Childrens Ibuprofen Oral SuspensionIBUPROFENReliable 1 Laboratories LLC28dd9baa-43bd-b60a-e063-6394a90a8cf72025-01-15WarningsExact identifier
unii: WK2XYI10QM
CombogesicACETAMINOPHEN AND IBUPROFENHikma Pharmaceuticals USA Incb32651c4-7fa0-415b-91eb-854aa1c28f2a2025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb2025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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