FDA.reportPublic FDA data

NDC 0338-9540-01 - Clinolipid

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
0338-9540
Requested NDC
0338-9540-01
Package NDCs from labels
0338-9540-04, 0338-9540-08, 0338-9540-03, 0338-9540-07, 0338-9540-02, 0338-9540-06, 0338-9540-01, 0338-9540-05
Manufacturer
Baxter Healthcare Corporation | Baxter SA | Baxter R&D Europe SPRL
Effective date
2025-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clinolipid - Baxter Healthcare Corporation | Baxter SA | Baxter R&D Europe SPRLBaxter Healthcare Corporation | Baxter SA | Baxter R&D Europe SPRL2025-07-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-9540-01Clinolipid100 mL in 1 BAGINJECTION, EMULSION10023
0338-9540-02Clinolipid250 mL in 1 BAGINJECTION, EMULSION25023
0338-9540-03Clinolipid500 mL in 1 BAGINJECTION, EMULSION50023
0338-9540-04Clinolipid1000 mL in 1 BAGINJECTION, EMULSION100023
0338-9540-05Clinolipid15 in 1 CARTONINJECTION, EMULSION1523
0338-9540-06Clinolipid10 in 1 CARTONINJECTION, EMULSION1023
0338-9540-07Clinolipid12 in 1 CARTONINJECTION, EMULSION1223
0338-9540-08Clinolipid6 in 1 CARTONINJECTION, EMULSION623

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9540CLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]20Current NDC, Legacy NDC, 8 package rows20250410_ae98eb03-c0e7-49d1-b024-77968e3d9d6e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9540-01ML - Milliliter0338-95407ed264c3-e2fc-4169-b66f-9c0136b386d412019-07-02
0338-9540-02ML - Milliliter0338-9540b0b2f114-43ed-4b3c-858a-fec30ab85a4812019-07-02
0338-9540-03ML - Milliliter0338-954090126cb2-8c21-4136-9e98-20694d29b4e112019-07-02
0338-9540-04ML - Milliliter0338-9540a57fe463-722e-4640-b04d-e1df0e6a504412019-07-02
0338-9540-05ML - Milliliter0338-95407672dc61-4f3a-43f1-8e52-18a985efdc9a12019-07-02
0338-9540-06ML - Milliliter0338-95409b40769c-3de8-4068-8003-e0bc77f481da12019-07-02
0338-9540-07ML - Milliliter0338-95405d9c6ecc-5f82-44af-979c-1cbf6ccd84ff12019-07-02
0338-9540-08ML - Milliliter0338-9540c02b0c24-3a15-4093-83f0-74a9953ec26212019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLIVE OILACTIVE INGREDIENT6UYK2W1W1ECLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
SOYBEAN OILACTIVE INGREDIENT241ATL177ACLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
OLIVE OILACTIVE MOIETY6UYK2W1W1ECLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
SOYBEAN OILACTIVE MOIETY241ATL177ACLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVCLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
SODIUM OLEATEINACTIVE INGREDIENT399SL044HNCLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1

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 10 of 18 · 350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh RelievaCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.6b984fa2-4187-45ef-b7d3-15e720abc6672025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Oasis Tears PF Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.640f95f4-c2e8-48ad-ad40-f76bbaddb0dc2025-09-12WarningsExact identifier
unii: PDC6A3C0OX
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
Oasis TEARS PF PLUS Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.5d080191-423d-4c0a-b5ae-2ccf5c4a67cb2025-09-08WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINRising Pharma Holdings, Inc.db539b39-9504-44d2-9bd5-ba6ffb4410242025-09-08WarningsExact identifier
unii: PDC6A3C0OX
Glycerin ChildrenGLYCERINRising Pharma Holdings, Inc.80a5a944-2882-4f8d-a955-ef827cead5f02025-09-08WarningsExact identifier
unii: PDC6A3C0OX
Foaming Facial CleanserGLYCERIN, NIACINAMIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd396c1db9-a5d3-cc82-e063-6294a90a90bb2025-08-23WarningsExact identifier
unii: PDC6A3C0OX
Refresh RELIEVA PFCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.d5d3df4a-a311-4f2d-9a24-edfec1a6c9f92025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Refresh OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
unii: PDC6A3C0OX
SmoflipidSMOFLIPIDFresenius Kabi USA, LLCe0e9d917-ff6f-488e-a6a8-0ad59dd17d802025-08-15Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
unii: 6UYK2W1W1E
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
unii: PDC6A3C0OX
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINKC Pharmaceuticals, Inc.3bc03d54-6b31-5921-e063-6294a90af5992025-08-01WarningsExact identifier
unii: PDC6A3C0OX
ClinolipidOLIVE OIL AND SOYBEAN OILBaxter Healthcare Corporationae98eb03-c0e7-49d1-b024-77968e3d9d6e2025-07-24Warnings, Adverse reactionsExact identifier
application number: NDA204508
ndc (package): 0338-9540-05
ndc (package): 0338-9540-01
ndc (package): 0338-9540-08
ndc (package): 0338-9540-02
ndc (package): 0338-9540-07
ndc (package): 0338-9540-03
ndc (package): 0338-9540-06
ndc (package): 0338-9540-04
ndc (product): 0338-9540
ndc11 (package): 00338954001
rxcui: 1986385
rxcui: 1986373
rxcui: 1986382
rxcui: 1986386
rxcui: 1986381
rxcui: 1986388
rxcui: 1986378
rxcui: 1986389
spl id: 548f8a90-9826-4750-8e46-d763bd586bf2
spl set id: ae98eb03-c0e7-49d1-b024-77968e3d9d6e
unii: 241ATL177A
unii: 6UYK2W1W1E
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
unii: PDC6A3C0OX
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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