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 61 of 74 · 1,465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
IbuprofenIBUPROFENA-S Medication Solutionsf1f1e0ac-6944-4123-9e08-1df91582d4572023-12-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions8553e29a-7f6f-4ff8-9991-836e619c504d2023-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENAmerican Health Packagingbc69d88b-d9af-4010-8e8f-e761a9e295a92023-12-05WarningsExact identifier
unii: WK2XYI10QM
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENA-S Medication Solutions7152b6ce-6113-4003-bf80-aa263be693922023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions400faee1-f662-470e-bcd6-7711dfaf9ba22023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENChain Drug Marketing Association Inc.e210c707-2bae-44a5-93dc-459dd24fd9602023-11-20WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENChain Drug Marketing Association Inc.c7e59784-a338-4922-a806-98c7505957cd2023-11-10WarningsExact identifier
unii: WK2XYI10QM
Concentrated ibuprofen infantsIBUPROFENChain Drug Marketing Association Inc.c9ae72d8-d205-4736-9bc4-2325cd77d36b2023-11-03WarningsExact identifier
unii: WK2XYI10QM
foster and thrive ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENStrategic Sourcing Services LLC8691e397-e598-4e23-a389-2dbbb8f4496a2023-11-01WarningsExact identifier
unii: WK2XYI10QM
foster and thrive ibuprofenIBUPROFENStrategic Sourcing Services LLC68d67a25-e669-47c7-8410-9f304b914ff12023-10-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGeri-Care Pharmaceutical Corp0744c3ca-4224-4f6a-a033-880949b544fd2023-10-30WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTIME CAP LABORATORIES, INC.059cb22f-f6db-5d03-e063-6294a90a9ec12023-10-27WarningsExact identifier
application number: ANDA079205
rxcui: 310964
unii: WK2XYI10QM
Dual Action Pain ReliefACETAMINOPHEN, IBUPROFENTIME CAP LABORATORIES, INC.08acd3bf-ad0c-f693-e063-6394a90ad8c22023-10-27WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENChain Drug Marketing Association Inc.ba0baba6-a7f9-4e4c-88f7-c7fbecc61f252023-10-25WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen minisIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2b9e71c5-9b32-4b1b-a479-e5457a1f9afd2023-10-16WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
ibuprofenIBUPROFENMeijer Distribution Ince578de96-747e-4104-8db6-e6521e6052a52023-10-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAsclemed USA, Inc.793e4b36-8208-4fa3-9f4f-9e9e726482802023-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepack8fafa916-733a-4c7d-99da-6ca2ed54e1e42023-10-06WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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