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 35 of 74 · 1,476 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENBryant Ranch Prepack230fd746-92e0-40b6-9a90-595812bd8a182025-08-20WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENMeijer Distribution Incd42f9f7c-fe4f-45eb-a455-bffb41295fdc2025-08-20WarningsExact identifier
unii: WK2XYI10QM
equaline childrens ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI3a166a74-cdc4-4620-b796-750464e15dc02025-08-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBJWC (Berkley & Jensen / BJ's)2f322afb-bfc8-9dab-e063-6394a90a08b52025-08-19WarningsExact identifier
application number: ANDA079205
rxcui: 310964
unii: WK2XYI10QM
IbuprofenIBUPROFENRite Aid Corporation9372c47d-2a3c-4f44-86f8-7568657844e72025-08-19WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
SmoflipidSMOFLIPIDFresenius Kabi USA, LLCe0e9d917-ff6f-488e-a6a8-0ad59dd17d802025-08-15Warnings, Adverse reactionsExact identifier
unii: C9H2L21V7U
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader63b8d389-7feb-41d2-8970-b7d5660ccb4a2025-08-14WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENFSA STORE INC.ec6b1b86-46fc-7e82-e053-2a95a90ac1472025-08-12WarningsExact identifier
application number: ANDA079205
rxcui: 310964
unii: WK2XYI10QM
Ammonia InhalantsAMMONIA INHALANTSDynarex Corporation91e27f1c-0f74-413e-97ff-2fc013f22ca82025-08-11WarningsExact identifier
unii: 5138Q19F1X
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Childrens IbuprofenIBUPROFENPrecision Dose Inc.fbbc67a7-359f-4155-9367-3815c05ccf032025-08-08WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENPrecision Dose Inc.59b881f9-1830-4bce-99d2-9770c9b2575f2025-08-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPROSTAT FIRST AID3bca27b4-3df6-b7d1-e063-6394a90ac6af2025-08-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCaf9ac948-440c-5abf-e053-2995a90af2b52025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
IbuprofenIBUPROFENEQUATE (WAL-MART STORES, INC.)104b5ac1-9c5e-40f8-a9b1-1761b495bb1c2025-08-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC3b9fdc48-c071-4e2c-e063-6294a90a679f2025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENMeijer, Inc.eed4f13d-4bee-4ccc-a651-a6f86d6d1f7b2025-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAsclemed USA, Inc.d7ed42c4-371c-4a54-ab15-0630656f04272025-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPHOENIX RX LLC3b17587e-b609-42a9-e063-6294a90ab1f82025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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