FDA.reportPublic FDA data

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 2 of 10 · 189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
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
LACTULOSELACTULOSECardinal Health 107, LLC3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd72026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
LactuloseLACTULOSEXttrium Laboratories, Inc.df62ad54-5aba-4d05-e053-2a95a90aa48d2026-04-14Warnings, Adverse reactionsExact identifier
application number: ANDA075911
ndc (package): 0116-4005-32
ndc (package): 0116-4005-08
ndc (package): 0116-4005-30
ndc (package): 0116-4005-41
ndc (package): 0116-4005-11
ndc (package): 0116-4005-15
ndc (package): 0116-4005-10
ndc (package): 0116-4005-16
ndc (package): 0116-4005-40
ndc (product): 0116-4005
ndc11 (package): 00116400541
rxcui: 391937
spl id: 4f6f0368-4b59-a9df-e063-6294a90ae43c
spl set id: df62ad54-5aba-4d05-e053-2a95a90aa48d
unii: 9U7D5QH5AE
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
LactuloseLACTULOSEChartwell RX, LLCd6975cd8-80e0-43e2-809a-175ea7e407152026-01-28Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Lactulose SolutionLACTULOSE SOLUTION USP, 10 G/15 MLRising Pharma Holdings, Inc.e75c335b-f19e-42e2-a24f-d891a52d3d342026-01-12Warnings, Adverse reactionsExact identifier
rxcui: 391937
unii: 9U7D5QH5AE
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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