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 28 of 74 · 1,476 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
unii: 6DC9Q167V3
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Hydrocodone Bitartrate and IbuprofenHYDROCODONE BITARTRATE AND IBUPROFENAmneal Pharmaceuticals of New York LLCabc33718-4e88-43ea-9ffa-2b04ffc812ef2025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
IbuprofenIBUPROFENAMERIFOODS TRADING COMPANY3802ebc9-83ca-602a-e063-6294a90a11c82025-11-20WarningsExact identifier
application number: ANDA079205
rxcui: 310964
unii: WK2XYI10QM
IbuprofenIBUPROFENGolden State Medical Supply, Inc.3ff501eb-5ae3-8824-e063-6394a90ac58e2025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES , LLC.8f9f099a-ee59-0b9a-e053-2a95a90a2fe12025-11-18WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENRETAIL BUSINESS SERVICES , LLC.8f9f40f5-625d-3f2e-e053-2a95a90a438b2025-11-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES , LLC.8f9f42a7-c2d8-4a51-e053-2a95a90a16772025-11-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES , LLC.8f9f308f-0ca5-12fa-e053-2995a90a47fc2025-11-18WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MOTRIN IBIBUPROFENR J General Corporationafa87bb5-7fcb-4ccd-acac-f7931242181f2025-11-17WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MGR J General Corporation68d3be55-9340-4cc9-a05a-12b9338ddc562025-11-17WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen 200 mgIBUPROFENR J General Corporationdd9aaf80-6c2b-41a3-87b9-61642aaed4f02025-11-17WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen 200 mgIBUPROFENR J General Corporation1c18a2da-1718-4c00-aea8-9fb4a34183122025-11-17WarningsExact identifier
rxcui: 310964
unii: WK2XYI10QM
Ibuprofen 200 mgIBUPROFENR J General Corporationcd3060a5-3b90-42e4-89cd-3b620859045f2025-11-17WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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