NDC 0116-4005-41 - Lactulose

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
0116-4005
Requested NDC
0116-4005-41
Package NDCs from labels
0116-4005-08, 0116-4005-16, 0116-4005-32, 0116-4005-15, 0116-4005-40, 0116-4005-10, 0116-4005-30, 0116-4005-41, 0116-4005-11
Manufacturer
Xttrium Laboratories, Inc.
Effective date
2026-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LACTULOSE SOLUTION, USPXttrium Laboratories, Inc.2026-04-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0116-4005-08Lactulose237 mL in 1 BOTTLESOLUTION2377
0116-4005-10Lactulose100 in 1 CASESOLUTION1007
0116-4005-11Lactulose100 in 1 CASESOLUTION1007
0116-4005-15Lactulose15 mL in 1 CUP, UNIT-DOSESOLUTION157
0116-4005-16Lactulose473 mL in 1 BOTTLESOLUTION4737
0116-4005-30Lactulose30 mL in 1 CUP, UNIT-DOSESOLUTION307
0116-4005-32Lactulose946 mL in 1 BOTTLESOLUTION9467
0116-4005-40Lactulose10 in 1 TRAYSOLUTION107
0116-4005-40Lactulose40 in 1 CASESOLUTION407
0116-4005-41Lactulose40 in 1 CASESOLUTION407
0116-4005-41Lactulose10 in 1 TRAYSOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-4005LACTULOSE SOLUTION [XTTRIUM LABORATORIES, INC.]6Current NDC, Legacy NDC, 11 package rows20250514_df62ad54-5aba-4d05-e053-2a95a90aa48d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0116-4005-08ML - Milliliter0116-4005f7ea2d68-651b-40ae-b2f8-a3eb54ef076f12023-10-16
0116-4005-11ML - Milliliter0116-40056ba03cdd-584d-42d1-9502-0a036d3803df12024-02-14
0116-4005-15ML - Milliliter0116-400511777ba0-6857-4c8d-8508-c3829847a24e12024-02-14
0116-4005-16ML - Milliliter0116-40053451d8c5-188f-4933-aba3-ae2f8e0fdbe512023-04-07
0116-4005-30ML - Milliliter0116-4005f1c0f6c8-48e0-41a6-b878-6217959a472112024-02-14
0116-4005-32ML - Milliliter0116-400523ad189f-3f05-4fb3-b711-3cb594e8928012024-02-14
0116-4005-40ML - Milliliter0116-400569479b61-fb23-48cd-b159-002da8f34bb212024-02-14
0116-4005-41ML - Milliliter0116-40056725bfb2-3713-441f-96d1-afc7805d526312024-02-14

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 4 of 10 · 189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LactuloseLACTULOSEChartwell Governmental & Specialty RX, LLC.887157ba-3c91-4fbf-bb12-b49c6fa4252c2025-11-13Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
LACTULOSELACTULOSEAtlantic Biologicals Corp.3fb6e908-893c-5a57-e063-6294a90a1bfc2025-09-26Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LACTULOSELACTULOSEPAI Holdings, LLC dba PAI Pharma0f19e4ed-c90a-4330-a7fa-bf911aa98f092025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
LACTULOSELACTULOSEPAI Holdings, LLC dba PAI Pharmacbf0497c-9c8d-4dfa-bebd-64c5894684012025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
LactuloseLACTULOSETrifluent Pharma, Inc.3eaf273a-b49d-2595-e063-6394a90a1cf62025-09-13Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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