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 64 of 68 · 1,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Talbots Vital 12CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUCTalbot's Pharmaceuticals Family Products, LLCc10bb804-8169-63da-e053-2a95a90a83062021-04-28WarningsExact identifier
unii: CI71S98N1Z
unii: 451W47IQ8X
Dr. Talbots Infant Daily Allergy ReliefALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUMTalbot's Pharmaceuticals Family Products, LLCc0963200-67dd-6349-e053-2a95a90adde12021-04-22WarningsExact identifier
unii: 451W47IQ8X
CLINIMIX ELEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSEBaxter Healthcare Company8469d6fb-d6ef-476f-8cc3-0905192de0a82021-04-13Warnings, Adverse reactionsExact identifier
unii: CI71S98N1Z
unii: 451W47IQ8X
unii: 4QD397987E
CLINIMIXLEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSEBaxter Healthcare Corporationdccff103-8695-400c-a15d-cc2fd078760a2021-04-13Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
Sodium ChlorideSODIUM CHLORIDEMedical Purchasing Solutions, LLCc3f8e83c-4fb9-91da-e053-2a95a90abd632021-04-12Adverse reactionsExact identifier
unii: 451W47IQ8X
CVS Health Sterile Saline Mist Live BetterSODIUM CHLORIDECVS Pharmacyccc3ab8c-b22f-420d-869b-f2a65b8c71802021-03-13WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationaeaed9cb-b629-4019-88d2-a916179427de2021-02-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GUNA KIDNEY PLUSCALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP -Guna spab8dacd94-8da1-4a8d-e053-2995a90acb672021-02-04WarningsExact identifier
unii: 451W47IQ8X
Natrum MuriaticumNATRUM MURIATICUMTrue Botanica, LLCb30b2880-28a1-47bd-83e7-da885a7c6f772021-01-24WarningsExact identifier
unii: 451W47IQ8X
Met-ToxARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODESwHITE mANUFACTURING INC DBA MICRO-WESTe65db4c2-0bc7-4c50-8f18-b36ee004c4f52021-01-21WarningsExact identifier
unii: 451W47IQ8X
HPZECHINACEA, GELSEMIUM, HYDRASTIS, HYPERICUM, LYCOPODIUM, NAT MUR, NITRICUM AC, RANUNC BULB, RHUS TOX, THUJA OCCWhite Manufacturing Inc. DBA Micro-Westdfbb5a35-8dfe-48f4-9177-6cb52fb440902021-01-21WarningsExact identifier
unii: 451W47IQ8X
Day and Night VitalsALLIUM SAT, ALOE, ARSENICUM ALB, BERBER VULG, CALC PHOS, CEANOTHUS, CHELIDONIUM MAJ, CHOLESTERINUM, CLEMATIS ERECTA, CONDURANGO, GAMBOGIA, HAMAMELIS, KALI BROM, KALI PHOS, LYCOPODIUM, NAT CARB, PASSIFLORA, SENNA, SILICEA, SOLIDAGO, SPIGELIA ANTH, SPONGIA, VERATRUM VIRNET Remediesd5ddba51-5f0c-4b06-8f87-3cd6faf64b792021-01-19WarningsExact identifier
unii: CI71S98N1Z
MetalALUMINIA, AMMON CARB, ANACARDIUM, ANTIMON CRUD, HYDRASTIS, IGNATIA, MAG PHOS, NAT MUR, NITRICUM AC, OSMIUM, PARAFFINUM, SENNA, SILICEA, SPONGIANET Remediesf7682a4e-c767-4429-98aa-e8c5ef6560a62021-01-19WarningsExact identifier
unii: 451W47IQ8X
FireAPIL MEL, BAPTISIA, BARYTA CARB, HAMAMELIS, KALI BROM, KALI PHOS, LACHESIS, LILIUM, PETROLEUM, PHOSPHORICUM AC, SPIGELIA ANTH, SULPHUR, VERATRUM VIRNET Remedies684d7ff2-b241-4c4e-9a16-14c9adfc260f2021-01-19WarningsExact identifier
unii: CI71S98N1Z
3% Sodium Chloride3% SODIUM CHLORIDEBecton Dickinson and Companya8058593-48af-457a-b0f0-166935c7d10c2021-01-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEAsclemed USA, Inc.a411c118-ef0e-4c42-9924-4a06ec690e942021-01-14Adverse reactionsExact identifier
unii: 451W47IQ8X
IntestiaECHINACEA, IRIS VERSICOLOR, URTICA URENS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, DIOSCOREA VILLOSA, I ODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RHUS TOXICODENDRON, PYROGENIUMNewton Laboratories, Inc.9a132c99-7278-f667-e053-2a95a90a3d2b2020-12-04WarningsExact identifier
unii: 451W47IQ8X
Multi-SystemACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, ARALIA QUINQUEFOLIA, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, ECHINACEA, IODIUM, KALI CARBONICUM, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, CANDIDA ALBICANS, THYROIDINUM, USTILAGO MAIDIS, ASPERGILLUS NIGER, CLADOSPORIUMNewton Laboratories, Inc.9a65b40b-873b-346a-e053-2995a90aa9682020-12-04WarningsExact identifier
unii: 451W47IQ8X
Nervousness - AnxietyACONITUM NAP., AMBRA, ANACARDIUM ORIENTALE, ARG. NIT., ASAFOETIDA, BRYONIA, CHAMOMILLA, CIMICIFUGA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HYOSCYAMUS, HYPERICUM, IGNATIA, KALI PHOS., NUX VOM., SAMBUCUS NIG., STRYCHNINUM, THERIDION, VALERIANA, PASSIFLORANewton Laboratories, Inc.99706ce2-d555-88ca-e053-2a95a90abb4b2020-12-04WarningsExact identifier
unii: CI71S98N1Z

Reported adverse events (FAERS/openFDA)#

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