FDA.reportPublic FDA data

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 3 of 25 · 498 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMUnited Natural Foods, Inc. dba UNFIbf87824a-522d-46da-81b6-e30ea11a22352026-06-11WarningsExact identifier
unii: PDC6A3C0OX
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: PDC6A3C0OX
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
unii: PDC6A3C0OX
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: PDC6A3C0OX
Nut AntigensARSENICUM ALBUM, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SULPHUR, ALMOND (NUT), CASHEW (NUT), BLACK WALNUT (NUT), PECAN (NUT), COCONUT, OLEUM OLEA EUROPAEA, CHESTNUT (NUT), WATER CHESTNUT (NUT), PINENUT (NUT), MACADAMIA (NUT), PISTACHIO (NUT), PEANUT (NUT), ENGLISH WALNUT (NUT), BRAZIL NUT (NUT), HAZELNUT (NUT), CARYA ALBABioActive Nutritional, Inc.fa2ac9d8-67e7-41b6-b57d-7b7cb29d05242026-04-23WarningsExact identifier
unii: 6UYK2W1W1E
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
unii: PDC6A3C0OX
PRENATE DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, FOLIC ACID, LEVOMEFOLATE CALCIUM, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, MAGNESIUM OXIDE AND DOCONEXENTAvion Pharmaceuticals, LLC8f2eca71-9a82-4a19-9206-36a04b865fe12026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7QWA1RIO01
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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