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 70 of 74 · 1,461 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Ibuprofen bubblegumIBUPROFENGuardian Drug Company9cb92af9-a829-4f54-b8f5-4e5cb4f165b72021-10-13WarningsExact identifier
unii: WK2XYI10QM
basic care infants ibuprofenIBUPROFENAmazon.com Services LLC1b5b96cc-40d4-4fb8-b429-cc1a5076fa772021-10-08WarningsExact identifier
unii: WK2XYI10QM
rexall ibuprofenIBUPROFENDolgencorp, LLC869185d5-9f34-4d38-9551-dd0b4fc8557d2021-09-09WarningsExact identifier
unii: WK2XYI10QM
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLC1204267a-5505-4257-837b-8902b75713472021-09-07WarningsExact identifier
unii: WK2XYI10QM
Migraine ReliefIBUPROFENBionpharma Inc.662ae0e0-bd44-4db4-8083-fc2e11d49abe2021-08-24WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLCb17b0aac-55d2-4917-a722-b8587ad643bc2021-08-13WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
dg health childrens ibuprofenIBUPROFENDolgencorp, LLCad8475b3-ace1-4a05-b927-3286a8139cb42021-05-26WarningsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENAphena Pharma Solutions - Tennessee, LLCb0f03994-b744-4d66-95b7-8c86217882bc2021-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
basic care infants ibuprofenIBUPROFENAmazon.com Services LLC581dca08-a4a4-476a-a7cf-fa0f8630c7772021-05-04WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAphena Pharma Solutions - Tennessee, LLC77adb094-869c-44b4-8a4e-b739ac9cd7012021-04-20Exact identifier
unii: WK2XYI10QM
IBUIBUPROFENAphena Pharma Solutions - Tennessee, LLC3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd2021-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ibuprofenIBUPROFENProficient Rx LP924d2dd0-3b7d-42ec-b617-86729dba2b952021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LPe23eb275-ce0c-40ec-b809-a48c5e46c7ec2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LP8813a8a4-ebbd-4204-88a3-600a92ea91702020-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENCVS Pharmacy60fd517d-608b-473e-8a44-eb98424599972020-10-22WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen IBIBUPROFENWINCO FOODS, LLC9d78644d-83c7-46d1-8156-0d76acb7c2992020-09-17WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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