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 5 of 10 · 186 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
LACTULOSE CrystallineLACTULOSECumberland Assured Products Inc.59e75426-42ae-4904-941f-009181101a8a2025-09-01Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LactuloseLACTULOSESun Pharmaceutical Industries, Inc.391cfd01-c1fa-41f9-abd7-d0abe9a276342025-08-04Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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