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 74 of 116 · 2,316 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips Salted Caramel, Candy Apple, Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company42cf4623-0eb8-455a-b374-8e17e9336b922024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips Peppermint Mocha, Apple Chai Cider, Orange CranberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company0338c078-695d-4d4e-9e90-5a8a98d495242024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips Tropical Coconut Peach PassionDIMETHICONEThe Mentholatum Company11f619e7-4a58-45e4-8f4a-fe358832ab642024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips Watermelon, Tropical Coconut, Peach PassionDIMETHICONEThe Mentholatum Companye9212502-909a-4184-905e-f31a53602c3b2024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips WatermelonDIMETHICONEThe Mentholatum Companye32d738e-e0af-4f17-a753-bdc7938b16842024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips Peach PassionDIMETHICONEThe Mentholatum Company4a133e73-e51b-4f04-91de-dc8c4d4dba302024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
unii: 8MDF5V39QO
Softlips RaspberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyd18b4c19-0365-44ec-bea8-4328e537e0d82024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company03062f13-270d-49cf-8939-2349f12e9cba2024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyf733747a-ad1a-4222-baf1-69dcd90a33502024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1fbe85a2-4cd7-45bd-85a2-83bbf75c5f972024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8d55141d-5d6f-4eec-87dc-d3c808cf7a6a2024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips Oasis Watermelon BlackberryDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companye1213808-4dad-4fd0-871a-04bba094a3cc2024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips PeppermintDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb272024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry KiwiDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Company7c8a4921-ae45-47fb-a64e-c72b1a386d0d2024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Medicated Lip Balm CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company6edb132d-bb67-4e6c-8e18-db0305073a712024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Medicated Lip Balm OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Companyf84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df12024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Natural Ice Sport SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company57c35631-42d3-4c6c-bcbb-e2de92b45b132024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
unii: PDC6A3C0OX
Softlips Cherry Cordial, Maple Butter, Frosted BerryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybab8447b-58b8-4160-a91e-05f9fd09ed1d2024-12-17WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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