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 66 of 74 · 1,465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
ChemDetoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUMDr. Donna Restivo DC2a17f80d-12c0-43a0-980b-9da648e9b76a2023-01-10WarningsExact identifier
unii: 506T60A25R
Topcare IbuprofenIBUPROFENTopco Associates LLC742f33fa-8923-4415-bcd6-8db37f2e19742023-01-06WarningsExact identifier
unii: WK2XYI10QM
Flex-PrinIBUPROFENProvision Medical Productsc01538b0-ca4c-434a-be8f-fe023deb84e12023-01-05WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENDOLGENCORP INC8f1358aa-495a-23da-e053-2995a90aa4302023-01-02WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)c62c6319-65eb-37e8-e053-2a95a90a9f902022-12-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWALGREEN COMPANY4ce20d2b-2dfb-4405-b545-dd1f67b2c5882022-12-28WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
Migraine ReliefIBUPROFENWALGREENS3d560acb-3334-4a39-9ab1-f131060e3b332022-12-28WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
Dye-Free Ibuprofen 200IBUPROFENWALGREEN COMPANYb9ff2469-22c7-fc70-e053-2a95a90abc492022-12-28WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
Dye-Free Ibuprofen 200IBUPROFENWALGREEN COMPANYbcd15c0f-8231-296f-e053-2995a90a280c2022-12-28WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWal-Mart Stores, Inc.ba31970a-b952-467c-b3f8-44f7a513de342022-12-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWal-Mart Stores, Inc.9e5332ab-92bc-3a33-e053-2995a90a642d2022-12-28WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.c483bbd6-934b-660a-e053-2995a90a51b32022-12-27WarningsExact identifier
unii: WK2XYI10QM
Dye-Free IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.d0eff659-6445-a56a-e053-2995a90a72e92022-12-27WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.553d16e1-928e-4919-bc53-6683a035e2b02022-12-27WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS Pharmacyce4378c0-848e-7878-e053-2a95a90af0f32022-12-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENKROGER COMPANY3b95dcbf-aef1-44b5-a2c4-5ce93c57ff1d2022-12-27WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.aa91952b-512f-0ead-e053-2995a90a94552022-12-21WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
Pediacare Childrens Ibuprofen BerryIBUPROFENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH347d081f-068c-4173-9b4b-001ab2b891f52022-12-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBionpharma Inc.ba89fbe6-546a-e10c-e053-2a95a90ade0c2022-12-20WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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