FDA.reportPublic FDA data

NDC 16571-246-16 - 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
16571-246
Requested NDC
16571-246-16
Package NDCs from labels
16571-246-16, 16571-246-72, 16571-246-03
Manufacturer
Rising Pharma Holdings, Inc. | Bliss GVS Pharma Limited
Effective date
2025-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mesalamine - Rising Pharma Holdings, Inc. | Bliss GVS Pharma LimitedRising Pharma Holdings, Inc. | Bliss GVS Pharma Limited2025-12-10Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-246-03Mesalamine5 in 1 CARTONSUPPOSITORY52
16571-246-16Mesalamine6 in 1 BLISTER PACKSUPPOSITORY62
16571-246-72Mesalamine12 in 1 CARTONSUPPOSITORY122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-246MESALAMINE SUPPOSITORY [RISING PHARMA HOLDINGS, INC.]1Current NDC, 3 package rows20250418_c26ae6cb-041b-4cfc-90ca-c4e1cb23458c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-246-03EA - Each16571-2467f55890c-6652-464b-8af5-5c414c6d977812025-05-14
16571-246-16EA - Each16571-246240dbdcd-e4a5-4d2b-ab24-d921fc53f64612025-06-13

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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PentasaMESALAMINETakeda Pharmaceuticals America, Inc.e39d9a3d-5d3a-4bb6-aab1-fdbb2a5986062025-01-15Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINENorthstar Rx LLC.7ac78fa0-60a8-48dd-abc4-a487f98039a22025-01-10Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
MesalamineMESALAMINETakeda Pharmaceuticals America, Inc.4e3b6325-a5bf-4c47-931c-142c0e4d7c3a2025-01-09Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAvPAKf2657911-6f06-71fb-e053-2a95a90ae6f72025-01-09Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEZydus Lifesciences Limitedaa63b4bb-2de7-40aa-b26b-1b00b0183eac2025-01-09Exact identifier
rxcui: 248420
unii: 4Q81I59GXC
MesalamineMESALAMINEZydus Pharmaceuticals USA Inc.f458d574-7b5b-44f1-86be-8b18880dc67f2025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
Bliss GVS HemorrhoidalHARD FAT, PHENYLEPHRINE HCLBliss GVS Pharma Limited88c49f6c-2a48-2dae-e053-2a95a90af20a2024-12-19WarningsExact identifier
unii: 8334LX7S21
mesalamineMESALAMINEZydus Lifesciences Limited29c0dd58-d2cf-40fa-bc32-0eab619373312024-11-30Exact identifier
unii: 4Q81I59GXC
mesalamineMESALAMINEZydus Lifesciences Limited52d96501-47f3-45d8-a181-98763b9f89652024-11-30Exact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEZydus Lifesciences Limited04073681-a834-4f45-91c5-224b608b30e62024-11-30Exact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAmerican Health Packaging77140634-9f32-40ca-8c83-9fcc3e373c162024-11-22Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINENorthStar RxLLC8233f158-9da5-4fd2-b2c3-9db89448371f2024-11-21Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAmerican Health Packaginga74ab9f4-ffcd-4bbf-88a5-342e6a38aabb2024-11-21Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEBryant Ranch Prepackb48df65a-a717-479e-9122-8b0f1406c8412024-11-01Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
CanasaMESALAMINEAllergan, Inc.89d91601-152b-4398-bebe-af1c023e99352024-09-08Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
MesalamineMESALAMINESun Pharmaceutical Industries Inc.c2f84490-70b8-4998-907d-a77e9f791de12024-08-27Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEBryant Ranch Prepackbaa76dde-3c5b-4ff4-ba0c-f19660a796c12024-08-14Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltda4ddf68d-1502-4242-89aa-c96436bdcbf62024-08-01Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAscend Laboratories, LLC43f69db3-81ac-4da4-a61f-fbba6299d9c22024-07-03Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINETeva Pharmaceuticals, Inc.e3b84397-a5a5-40cf-8145-0584103d465f2024-06-28Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC

Reported adverse events (FAERS/openFDA)#

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