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 48 of 74 · 1,476 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen, Caseys 4goodIBUPROFEN TABLETSLil' Drug Store Products, Inc.04b3ad8b-bdf9-47f3-e063-6294a90ac3502024-12-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTrifecta Pharmaceuticals USA LLC09972806-e064-238d-e063-6394a90a74342024-12-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCaf9af7f4-6314-6217-e053-2995a90a5a0f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCb33caad1-8d40-16f2-e053-2a95a90a1b2d2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCc859cc7a-e13a-7df4-e053-2a95a90a47d62024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCbd1ca7af-d640-23fb-e053-2a95a90a8a982024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCf18b6a0a-e42f-083d-e053-2995a90a40e42024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
IbuprofenIBUPROFENSpirit Pharmaceutical LLC59c77fd3-5e67-45ec-82ad-44585390c4f32024-12-30WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLC2810122e-3c89-49a2-8dac-db3714cb7b452024-12-30WarningsExact identifier
application number: ANDA079205
ndc (package): 68210-0200-1
ndc (product): 68210-0200
ndc11 (package): 68210020001
rxcui: 310964
spl id: 2a810b8f-18a5-5938-e063-6394a90a8ea7
spl set id: 2810122e-3c89-49a2-8dac-db3714cb7b45
unii: WK2XYI10QM
IbuprofenIBUPROFENSpirit Pharmaceutical LLCa96d012e-b132-4e99-b84b-ccd3a9a05cbb2024-12-30WarningsExact identifier
unii: WK2XYI10QM
Cabinet Pain Reliever and Fever ReducerIBUPROFENSpirit Pharmaceutical LLCe172a8d8-779d-4ad9-b6b0-08a198a580342024-12-30WarningsExact identifier
unii: WK2XYI10QM
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedADVIL PMLil Drug Store Products, Incd1138e15-8ae4-7b49-e053-2995a90a96072024-12-30WarningsExact identifier
unii: WK2XYI10QM
Advil Liqui-GelsIBUPROFEN CAPSULE, LIQUID-FILLEDLil' Drug Store Products, Inc.c459ea1e-dabf-bba6-e053-2995a90af40f2024-12-30WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLC09bd3935-526d-4ad1-898a-4f0d9499ebb92024-12-26WarningsExact identifier
unii: WK2XYI10QM
Aacetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENGRANULES USA, INC.1dd90684-6505-8e07-e063-6394a90afdf42024-12-26WarningsExact identifier
unii: WK2XYI10QM
Glitch Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLMisemer Pharmaceutical, Inc03778509-3374-2168-e063-6294a90a95052024-12-23WarningsExact identifier
unii: B697894SGQ
Childrens Ibuprofen Oral SuspensionIBUPROFENChain Drug Marketing Association, Inc.f0959369-890e-403e-8a98-4eda340a07832024-12-23WarningsExact identifier
unii: WK2XYI10QM
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 6DC9Q167V3
IbuprofenIBUPROFENSpirit Pharmaceutical LLC9a93d4a8-07a1-4ac5-9bd9-5d5e4e62c2af2024-12-20WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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