NDC 63323-820-01 - Smoflipid

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
63323-820
Requested NDC
63323-820-01
Package NDCs from labels
63323-820-01, 63323-820-00, 63323-820-02, 63323-820-12, 63323-820-04, 63323-820-74, 63323-820-03, 63323-820-50, 63323-820-05, 63323-820-10
Manufacturer
Fresenius Kabi USA, LLC | Fresenius Kabi AB
Effective date
2025-08-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Smoflipid - Fresenius Kabi USA, LLC | Fresenius Kabi ABFresenius Kabi USA, LLC | Fresenius Kabi AB2025-08-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-820-00Smoflipid10 in 1 CASEINJECTION, EMULSION1011
63323-820-01Smoflipid100 mL in 1 BAGINJECTION, EMULSION10011
63323-820-02Smoflipid100 mL in 1 BAGINJECTION, EMULSION10011
63323-820-03Smoflipid500 mL in 1 BAGINJECTION, EMULSION50011
63323-820-04Smoflipid250 mL in 1 BAGINJECTION, EMULSION25011
63323-820-05Smoflipid1000 mL in 1 BAGINJECTION, EMULSION100011
63323-820-10Smoflipid6 in 1 CASEINJECTION, EMULSION611
63323-820-12Smoflipid20 in 1 CASEINJECTION, EMULSION2011
63323-820-50Smoflipid12 in 1 CASEINJECTION, EMULSION1211
63323-820-74Smoflipid10 in 1 CASEINJECTION, EMULSION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-820SMOFLIPID (SMOFLIPID) INJECTION, EMULSION [FRESENIUS KABI USA, LLC ]10Current NDC, Legacy NDC, 10 package rows20230729_e0e9d917-ff6f-488e-a6a8-0ad59dd17d80.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-820-01ML - Milliliter63323-8201c7c6dd8-3a51-4e2e-babb-5ec0ee0fd44612019-09-05
63323-820-03ML - Milliliter63323-82069f529a3-6330-46d1-97df-6bc42173623f12019-09-05
63323-820-04ML - Milliliter63323-820856820e6-848a-4ed7-93ea-9d6d550b386d12019-09-05
63323-820-05ML - Milliliter63323-8203e203373-02ac-4831-9e88-b4008a2c88c212019-06-19
63323-820-10ML - Milliliter63323-820d5536998-760a-44b1-8e24-7eab7a0eb99112019-06-19

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 8 of 25 · 498 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Family Wellness Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLFamily Dollar Services, Inc.facd53c4-9cfc-6589-e053-6394a90a180d2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEK.C. Pharmaceuticals, Inc.f7131707-47af-d70a-e053-6394a90a418f2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: PDC6A3C0OX
DG Maximum Strength Redness ReliefGLYCERIN, NAPHAZOLINE HCLDolgencorp, Inc9cb261ed-b708-1189-e053-2a95a90a547d2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Winco Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWinCo Foods, LLCff3651d4-42ce-4db1-a318-15f7592baf862025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Harris Teeter Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLCf710d107-0403-21c5-e053-6394a90a03722025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Foster and Thrive Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLStrategic Sourcing Services LLC0042e9a0-9693-d7e0-e063-6294a90ae6c62025-12-30WarningsExact identifier
unii: PDC6A3C0OX
CareOne Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCIRetail Business Services, LLC9ab96aed-21d3-11b6-e053-2995a90a72252025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Equate Redness and Dry Eye Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWal-Mart Stores, Inc.ae228018-9238-2cbd-e053-2995a90a8d992025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Equate Optimal Hydration Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart, Inc.151b9723-5d5e-ac2b-e063-6294a90af0732025-12-30WarningsExact identifier
unii: PDC6A3C0OX
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
OUHOE Face Body SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46d36f60-2a5d-816e-e063-6294a90a2ddc2025-12-26WarningsExact identifier
unii: 6UYK2W1W1E

Reported adverse events (FAERS/openFDA)#

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