FDA.reportPublic FDA data

NDC 58160-730 - PENMENVY

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
58160-730
Package NDCs from labels
58160-730-03
Manufacturer
GlaxoSmithKline Biologicals SA
Effective date
2025-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PENMENVY - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2025-08-01VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-730-03PENMENVY0.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,5 mL5 ug in 0.5mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-730PENMENVY (MENINGOCOCCAL (GROUPS A, B, C, W AND Y)) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]1Unmatched20250221_6b2c9ee3-ae88-46f1-9b3f-fc9e9e716cbf.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 52 of 68 · 1,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Saccharum officinaleSUCROSEBoiron86d05561-6f09-6f1f-e053-2a91aa0a4b982023-11-14Exact identifier
unii: C151H8M554
Kali phosphoricumDIBASIC POTASSIUM PHOSPHATEBoiron8609f915-777a-ccb8-e053-2991aa0ad1c62023-11-13Exact identifier
unii: CI71S98N1Z
Kali phosphoricumDIBASIC POTASSIUM PHOSPHATEBoiron860a1aa4-c69e-217b-e053-2a91aa0a855e2023-11-13Exact identifier
unii: CI71S98N1Z
Kali phosphoricumDIBASIC POTASSIUM PHOSPHATEBoiron860a8b29-da07-7e24-e053-2991aa0a5d132023-11-13Exact identifier
unii: CI71S98N1Z
Kali phosphoricumDIBASIC POTASSIUM PHOSPHATEBoiron860ad64d-3977-0315-e053-2a91aa0accee2023-11-13Exact identifier
unii: CI71S98N1Z
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd00ead8-026c-6610-e053-6394a90a0f112023-11-08WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd67566a-1078-019d-e053-6394a90a415c2023-11-08WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONESTRATEGIC SOURCING SERVICES LLCfd7a0a90-6570-c722-e053-6394a90a03f42023-11-08WarningsExact identifier
unii: 5QB0T2IUN0
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d6916ec-e87f-6421-e053-2991aa0a33642023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d68366d-fee9-2acf-e053-2991aa0a7e4b2023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d7ed0c5-911c-299a-e053-2a91aa0aae562023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5e1eed65-0d4c-2d02-e053-2991aa0a95c12023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONECARDINAL HEALTH7ee3618a-43c8-2ccc-e053-2a91aa0a81152023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECARDINAL HEALTH7ee2f64b-9719-6aa0-e053-2991aa0aeb482023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHaf5ea189-2118-4ffd-e053-2995a90aecfd2023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHb1a3cef7-a05e-bb39-e053-2995a90abfb52023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa9654a96-9bfd-60ea-e053-2995a90ae38d2023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEH E Babfe6688-f852-ba8e-e053-2995a90a49a32023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGOODSENSEa9654a96-9bf9-60ea-e053-2995a90ae38d2023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
ADVANCED ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa964da1d-e1e3-94a8-e053-2a95a90ac8042023-11-07WarningsExact identifier
unii: 5QB0T2IUN0

Reported adverse events (FAERS/openFDA)#

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