FDA.reportPublic FDA data

NDC 55154-2305-6 - Asacol

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
55154-2305
Requested NDC
55154-2305-6
Package NDCs from labels
55154-2305-6, 55154-2305-4, 55154-2305-8, 55154-2305-2, 55154-2305-0
Manufacturer
Cardinal Health
Effective date
2017-10-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Asacol - Cardinal HealthCardinal Health2017-10-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
mesalamineACTIVE INGREDIENT4Q81I59GXCASACOL (MESALAMINE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]3
mesalamineACTIVE MOIETY4Q81I59GXCASACOL (MESALAMINE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]3
ferric oxide redINACTIVE INGREDIENT1K09F3G675ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]3
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTASACOL (MESALAMINE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XASACOL (MESALAMINE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]3
magnesium stearateINACTIVE INGREDIENT70097M6I30ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]3
methacrylic acid - methyl methacrylate copolymer (1:2)INACTIVE INGREDIENT5KY68S2577ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]3
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AASACOL (MESALAMINE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]3
povidoneINACTIVE INGREDIENTFZ989GH94EASACOL (MESALAMINE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]3
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]3
talcINACTIVE INGREDIENT7SEV7J4R1UASACOL (MESALAMINE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]3

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 1 of 10 · 181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
APRISOMESALAMINESalix Pharmaceuticals, Inc.7951139c-b271-45a4-b523-34b23800917b2026-08-27Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
RowasaMESALAMINEViatris Specialty LLCe505ab99-1943-4216-a178-4d5dbe64e3b22026-08-03Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
mesalamineMESALAMINEMajor Pharmaceuticals14ac4435-903b-41f5-a3c4-8c73de3e4cef2026-07-27Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
mesalamineMESALAMINEZydus Pharmaceuticals USA Inc.ad8c7930-92e2-4372-a874-da22b9ae333e2026-07-14Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINESandoz Inc47b5d1ee-b439-4ccb-9b01-c0875ccd748a2026-06-30Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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