FDA.reportPublic FDA data

NDC 45802-923-49 - Mesalamine

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
45802-923
Requested NDC
45802-923-49
Package NDCs from labels
45802-923-41, 45802-923-49
Manufacturer
Bryant Ranch Prepack
Effective date
2024-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mesalamine - Bryant Ranch PrepackBryant Ranch Prepack2024-11-07HUMAN PRESCRIPTION DRUG LABEL
Mesalamine - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2024-08-01HUMAN PRESCRIPTION DRUG LABEL
Mesalamine - Perrigo New York IncPerrigo New York Inc2019-08-15HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-098-46Mesalamine60 mL in 1 BOTTLEENEMA420 mL4 g in 60mL14
45802-923-41Mesalamine1 in 1 CARTONKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-923MESALAMINE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]14Current NDC, Legacy NDC, 2 package rows20241017_d50f2c37-5675-49f3-bdd4-3b16d333ed40.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-923-41EA - Each45802-923ff56bce9-918f-4737-9443-505a0c3cc29212012-07-24
45802-923-49EA - Each45802-923730d663e-9f62-4882-a01f-5031f344fdba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MESALAMINEACTIVE INGREDIENT4Q81I59GXCMESALAMINE KIT [PERRIGO NEW YORK INC]3
MESALAMINEACTIVE MOIETY4Q81I59GXCMESALAMINE KIT [PERRIGO NEW YORK INC]3
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31MESALAMINE KIT [PERRIGO NEW YORK INC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMESALAMINE KIT [PERRIGO NEW YORK INC]3
POTASSIUM ACETATEINACTIVE INGREDIENTM911911U02MESALAMINE KIT [PERRIGO NEW YORK INC]3
POTASSIUM METABISULFITEINACTIVE INGREDIENT65OE787Q7WMESALAMINE KIT [PERRIGO NEW YORK INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMESALAMINE KIT [PERRIGO NEW YORK INC]3
WATERINACTIVE INGREDIENT059QF0KO0RMESALAMINE KIT [PERRIGO NEW YORK INC]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMESALAMINE KIT [PERRIGO NEW YORK INC]3
MESALAMINEACTIVE INGREDIENT4Q81I59GXCMESALAMINE KIT [PERRIGO NEW YORK INC]2
MESALAMINEACTIVE MOIETY4Q81I59GXCMESALAMINE KIT [PERRIGO NEW YORK INC]2
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31MESALAMINE KIT [PERRIGO NEW YORK INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMESALAMINE KIT [PERRIGO NEW YORK INC]2
POTASSIUM ACETATEINACTIVE INGREDIENTM911911U02MESALAMINE KIT [PERRIGO NEW YORK INC]2
POTASSIUM METABISULFITEINACTIVE INGREDIENT65OE787Q7WMESALAMINE KIT [PERRIGO NEW YORK INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMESALAMINE KIT [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RMESALAMINE KIT [PERRIGO NEW YORK INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMESALAMINE KIT [PERRIGO NEW YORK INC]2

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 11 of 24 · 465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Emetrol CherryPHOSPHORATED CARBOHYDRATEWellSpring Pharmaceutical Corporationa8469128-592a-4682-82c7-4d2a6f97a9982025-06-10WarningsExact identifier
unii: IY9XDZ35W2
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 33X04XA5AT
MesalamineMESALAMINETeva Pharmaceuticals USA, Inc.6fd0a906-e1b5-4238-a79b-a195510ddc842025-05-30Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: OJ245FE5EU
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
MesalamineMESALAMINEAmerican Health Packaginge638681d-8fca-4bf8-a1fb-8e52357a64da2025-05-21Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC8fafc39b-69db-40f3-8a09-ee859e8cef192025-05-15Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
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
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEAilex Pharmaceuticals, LLC329655ae-c3c0-46b2-a925-e49777f2076b2025-03-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
MesalamineMESALAMINEActavis Pharma, Inc.ba1e3bd4-fbe0-46a5-961e-167ccb09672c2025-03-27Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: OJ245FE5EU
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Medicated Foaming FeminineLACTIC ACID, BORIC ACID, CHLORHEXIDINE GLUCONATE, CNIDIUM MONNIERI FRUIT, LEVOMENOLRida LLC02b3d683-05b0-4075-bbf9-e6d97c61765c2025-03-06WarningsExact identifier
unii: 24WE03BX2T
unii: 33X04XA5AT
Bestmade Natural Products BM230ACID BENZ, CIMICIFUGA, COLCHICUM, LEDUM, PULSATILLA, RUTA GR, CALC PHOSBestmade Natural Products2f80cfae-5f8c-7cbf-e063-6394a90a43fd2025-03-04WarningsExact identifier
unii: 8SKN0B0MIM
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM184BENZOIC ACID, BUCHU, BELLADONNA, TEREBINTHINA, THLAPSI B.P, TRITICUM REPBestmade Natural Products2e9211e3-0e20-741e-e063-6394a90a4da12025-02-20WarningsExact identifier
unii: 8SKN0B0MIM
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3
unii: 33X04XA5AT
QIDILA Whitening Skin Lightening CreamBUTYLENE GLYCOL,BUTYROSPERMUM PARKII (SHEA BUTTER),KYOUNIN YU,TOCOPHEROL,ASCORBIC ACID,NIACINAMIDEBeijing JUNGE Technology Co., Ltd.2e66a508-3f56-4500-e063-6394a90aaa9d2025-02-18WarningsExact identifier
unii: 3XUS85K0RA

Reported adverse events (FAERS/openFDA)#

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