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 38 of 74 · 1,476 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUIBUPROFENDr. Reddy's Laboratories Limited24731405-219c-79b4-ecf0-7d5fbfda94ba2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofen 200IBUPROFENWalgreen Company49a3d51d-55d1-4b80-ab7b-35c27a937cb92025-07-02WarningsExact identifier
unii: WK2XYI10QM
Topcare ibuprofenIBUPROFENTopco Associates LLC479a0c97-dbd9-47ad-9910-9dd4edf5136f2025-07-02WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS Pharmacye241ca5f-04bd-4bc9-bd0c-ca22841c4a3c2025-07-01WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI37eaa3b1-98e9-4fcf-ae74-153bfc35551f2025-07-01WarningsExact identifier
application number: ANDA079205
rxcui: 310964
unii: WK2XYI10QM
IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI7b2f7a68-8f5e-a340-e053-2991aa0a5aeb2025-07-01WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI8fecb3a8-d288-cacf-e053-2a95a90ae2382025-07-01WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI8fed1f86-49a0-4747-e053-2a95a90a42b82025-07-01WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Consortium, LLCf0f01b97-e52c-4077-a4c6-c59736f4c1712025-06-30WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC388e68dc-1822-f375-e063-6294a90a3d412025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
JUNIOR STRENGTH ADVILIBUPROFENHaleon US Holdings LLC07d4c400-b182-92f7-7574-9e0e94c39cce2025-06-27WarningsExact identifier
unii: WK2XYI10QM
leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader009dde4c-d944-4206-8c9f-35bc8fd927152025-06-26WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen ChildrensIBUPROFENKroger Company47a3b118-614d-405d-b80e-31f0b354c4302025-06-25WarningsExact identifier
unii: WK2XYI10QM
Good Neighbor Pharmacy Childrens IbuprofenIBUPROFENAmerisource Bergen40a6a842-a85b-4e24-8786-32ecd74f68702025-06-25WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENSafeway1b7854d6-32b9-4410-bb40-0f02e46c79662025-06-24WarningsExact identifier
unii: WK2XYI10QM
ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENKroger Company347dd263-ba0d-4a5a-8ac8-e586fcfd014e2025-06-23WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENWalgreen Company9c5c1f48-d285-4faa-96d0-b04f435c9c5c2025-06-23WarningsExact identifier
unii: WK2XYI10QM
Motrin IBIBUPROFENMorning Star OTCe69f00c4-b8ec-4a83-9eea-8cb2835ad7762025-06-19WarningsExact identifier
unii: WK2XYI10QM
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
unii: 506T60A25R
IBUPROFENIBUPROFENAAA Pharmaceutical, Inc.1e686091-6456-36c8-e063-6294a90a38662025-06-17WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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