FDA.reportPublic FDA data

NDC 0121-4577-30 - 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
0121-4577
Requested NDC
0121-4577-30
Package NDCs from labels
0121-4577-15, 0121-4577-40, 0121-4577-06, 0121-4577-50, 0121-4577-30
Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2025-09-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lactulose Solution USP 10 g/15 mLPAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma2025-09-15HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-4577-06LACTULOSE6 in 1 CASESOLUTION622
0121-4577-06LACTULOSE16 in 1 CARTONSOLUTION1622
0121-4577-15LACTULOSE15 mL in 1 CUP, UNIT-DOSESOLUTION1522
0121-4577-40LACTULOSE4 in 1 CASESOLUTION422
0121-4577-40LACTULOSE10 in 1 TRAYSOLUTION1022
0121-4577-50LACTULOSE5 in 1 TRAYSOLUTION522
0121-4577-50LACTULOSE5 in 1 CASESOLUTION522

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-4577LACTULOSE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]21Current NDC, Legacy NDC, 7 package rows20241114_0f19e4ed-c90a-4330-a7fa-bf911aa98f09.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4577-06ML - Milliliter0121-4577672adaf2-245b-428a-9f01-4b0a6413509312020-01-03
0121-4577-15ML - Milliliter0121-4577eba61e72-972b-4697-8cc9-a153ee50ab5912013-02-13
0121-4577-30ML - Milliliter0121-4577f2e1c85d-d351-405b-8d5b-ecbbfe6d376912013-02-13
0121-4577-35ML - Milliliter0121-4577c5da7441-ee43-4089-ba07-b41abc8ef49112014-09-03
0121-4577-40ML - Milliliter0121-45776966f60d-98ff-4174-8c16-95b21dea688f12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LACTULOSEACTIVE INGREDIENT9U7D5QH5AELACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]4
LACTULOSEACTIVE MOIETY9U7D5QH5AELACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]4
WATERINACTIVE INGREDIENT059QF0KO0RLACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]4

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
application number: ANDA074623
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
rxcui: 391937
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.