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 3 of 10 · 189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
LactuloseLACTULOSEAPOZEAL PHARMACEUTICALS INCa8af7389-3699-4873-b05a-509af7e8eaab2026-01-06Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
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
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
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LactuloseLACTULOSEFoxland Pharmaceuticals, Inc.3363bdbd-f0d1-45b3-8193-7fdb0a310cc22025-12-16Warnings, Adverse reactionsExact identifier
unii: 9U7D5QH5AE
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
LactuloseLACTULOSEChartwell RX, LLC.bd9f1577-65e8-4521-b176-e5fc60a4a0182025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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