FDA.reportPublic FDA data

NDC 58160-958 - Menveo

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
58160-958
Package NDCs from labels
58160-958-01
Manufacturer
GlaxoSmithKline Biologicals SA
Effective date
2025-03-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Menveo - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2025-03-31VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-958-01Menveo0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,2.5 mL10 ug in 0.5mL19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-958MENVEO (MENINGOCOCCAL (GROUPS A, C, Y AND W-135) OLIGOSACCHARIDE DIPHTHERIA CRM197 CONJUGATE VACCINE) KIT MENVEO (MENINGOCOCCAL (GROUPS A, C, Y AND W-135) OLIGOSACCHARIDE DIPHTHERIA CRM197 CONJUGATE VACCINE) INJECTION, SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA]18Unmatched20250406_2dc730d5-55fd-4e98-8c8a-daa7d8f872b0.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 55 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: 451W47IQ8X
Metabolic SupportFUCUS VESICULOSUS, AGNUS CASTUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHYTOLACCA DECANDRA, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, CARBO VEGETABILIS, GRAPHITES, CALCAREA CARBONICA, NATRUM PHOSPHORICUM, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, THYROIDINUM (SUIS)BodyLogicMD of Fort Lauderdalec2a1bd6d-c595-402f-a3bc-23f64c949d782018-06-08WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation181705c7-40e4-4d7d-b9ea-ada99380e7a92018-05-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation7c72520e-de3c-493d-8aea-11933376d9682018-04-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDEBaxter Healthcare Company5215ec33-8cfe-4885-ae92-e6a12100bd272018-01-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Homeoplex BARSENICUM ALBUM, CALCAREA CARBONICA , IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA, STAPHYSAGRIASupplement Clinic, LLC.e9a9c58e-1b70-4ac8-9d9c-108c628d76642017-10-31WarningsExact identifier
unii: 451W47IQ8X
Spleen-Pro T018SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUSGuangzhou Renuma Medical Systems Co., Ltdbc2b70bd-2a4a-46fb-b3d8-d69b61056b892017-10-26WarningsExact identifier
unii: 451W47IQ8X
Female Vitality T010CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIAGuangzhou Renuma Medical Systems Co., Ltd694f0c36-b656-471a-9f38-2efb5193e05a2017-10-20WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company886f889b-f3cf-4197-b307-6cfa88c894362017-05-04Exact identifier
unii: 451W47IQ8X
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corp9883c502-9782-451e-9eec-c54d7b054f312017-01-31WarningsExact identifier
unii: 451W47IQ8X
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
URELLEHYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEViatris Specialty LLC1d80a11c-6f86-403b-85d4-32ec1924dbe92015-01-13Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.051f7347-5a76-4664-8fe2-e61b3dfcb0e42014-08-27Exact identifier
unii: 593YOG76RN
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2a96096d-43cc-49b7-af53-b53c17f410012014-07-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationb3b4b176-41f0-4ca8-90d4-3fba5707564a2014-02-21Exact identifier
unii: 451W47IQ8X
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
unii: 4J9FJ0HL51
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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