FDA.reportPublic FDA data

NDC 65628-271 - Konvomep

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
65628-271
Package NDCs from labels
65628-271-03, 65628-271-05, 65628-271-10
Manufacturer
Azurity Pharmaceuticals, Inc.
Effective date
2025-12-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Konvomep - Azurity Pharmaceuticals, Inc.Azurity Pharmaceuticals, Inc.2025-12-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65628-271-03Konvomep90 mL in 1 BOTTLESOLUTION90 mL84 mg in 1mL6
65628-271-05Konvomep150 mL in 1 BOTTLESOLUTION150 mL84 mg in 1mL6
65628-271-10Konvomep300 mL in 1 BOTTLESOLUTION300 mL84 mg in 1mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65628-271KONVOMEP (OMEPRAZOLE AND SODIUM BICARBONATE) KIT [AZURITY PHARMACEUTICALS, INC.]5Unmatched20241208_688ed6f1-d78a-4006-a682-57021cb38a3e.zip

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 99 of 116 · 2,316 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane LubricantPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.15bc06ec-f3dc-3180-ca1a-106769a770ea2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.7eaa93ca-c843-4c89-921b-c76659410dce2023-12-14WarningsExact identifier
unii: 6DC9Q167V3
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
unii: 6DC9Q167V3
OmeprazoleOMEPRAZOLEA-S Medication Solutionsa52842ac-ac9d-4344-9823-b8b2afb079032023-12-14WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEVALU MERCHANDISERS COMPANY7b2d41b6-3e36-4973-b5f6-adf9b828f40d2023-12-13WarningsExact identifier
unii: KG60484QX9
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.aa694e0d-7891-4870-8106-dd57f1e29fb42023-12-11WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.ed1b03f0-fabc-4c1c-8e6d-9f15c380300c2023-12-11WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin ProtectantGLYCERINL'Oreal USA Products Inc32eaaaab-41bd-4efe-a71d-92e3a702c1e52023-12-11WarningsExact identifier
unii: PDC6A3C0OX
Family Wellness HEMORRHOIDGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLFAMILY DOLLAR (Family Wellness)16ceb129-5c0a-428a-a867-cfbbb08bb62a2023-12-11WarningsExact identifier
unii: PDC6A3C0OX
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5GLYCERINCosmetique Active Production01c8a0d5-bcd1-4639-be45-530a226401f02023-12-11WarningsExact identifier
unii: PDC6A3C0OX
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: B22547B95K
Sodium Bicarbonate AntacidSODIUM BICARBONATERugby Laboratoriese73b5871-4a87-4473-ab00-5e5395be017d2023-12-06WarningsExact identifier
unii: 8MDF5V39QO
Hemorrhoidal Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
Mylanta Gas Minis Mint FlavorSIMETHICONEInfirst Healthcare Inc.5045b945-23ee-4c25-a32c-af3cd5045c732023-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Gas Minis Assorted Fruit FlavorSIMETHICONEInfirst Healthcare Inc.c6db9af2-d457-477d-baa9-470ddbba59052023-12-04WarningsExact identifier
unii: 92RU3N3Y1O
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
unii: 8MDF5V39QO
Infants Non-staining Gas reliefSIMETHICONEH E B99d94de2-9550-4d2d-99d4-1be0ef7b78802023-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Childrens Mylicon Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.432d5b4c-a69b-45f9-b7f0-216726a3eead2023-12-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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