FDA.reportPublic FDA data

NDC 53499-3391-01 - Migraide

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
53499-3391
Requested NDC
53499-3391-01
Package NDCs from labels
53499-3391-1, 53499-3391-01
Manufacturer
Schwabe North America, Inc. | Schwabe Mexico, S.A. de C.V.
Effective date
2022-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Migraide TabletsSchwabe North America, Inc. | Schwabe Mexico, S.A. de C.V.2022-03-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-3391-1Migraide4 in 1 BOXtablet42
53499-3391-1Migraide10 in 1 BLISTER PACKtablet102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-3391MIGRAIDE (CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT) TABLET [SCHWABE NORTH AMERICA, INC.]2Current NDC, Legacy NDC, 2 package rows20220405_0dc575dd-ef7e-4f91-a2b3-0ea3637a871e.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 12 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menstrual - PMSANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, DIOSCOREA, FOLLICULINUM, GELSEMIUM, LACHESIS, LILIUM, LYCOPODIUM, MILLEFOLIUM, NUX VOM., PULSATILLA, SABINA, SECALE, SEPIA,THLASPI, VIBURNUM OP., ZINGIBER, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4a13c3-87ff-e833-e053-2995a90a8aba2023-11-02WarningsExact identifier
unii: K73E24S6X9
Sanguinaria canadensisSANGUINARIA CANADENSIS ROOTBoiron86ce0334-e325-8f27-e053-2991aa0a857e2023-10-30Exact identifier
unii: N9288CD508
SinusCalmATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIABoiron95872748-6d70-5c80-e053-2995a90a570c2023-10-30Exact identifier
unii: N9288CD508
Sanguinaria canadensisSANGUINARIA CANADENSIS ROOTBoiron86cf43b9-30ab-77ca-e053-2a91aa0a6cae2023-10-16Exact identifier
unii: N9288CD508
Joint Tone AICIMICIFUGA RACEMOSA, LAPPA MAJOR, TRIFOLIUM PRATENSE, COLCHICUM AUTUMNALE, DULCAMARA, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), RHODODENDRON CHRYSANTHUM, RHUS TOXEnergique, Inc.bcd543aa-eb43-455e-9a73-37323f050e242023-10-04WarningsExact identifier
unii: K73E24S6X9
ZeelALPHA LIPOIC ACID, ARNICA MONTANA WHOLE,SUS SCROFA CARTILAGE, COENZYME A,SOLANUM DULCAMARA TOP,SUS SCROFA EMBRYO,SUS SCROFA UMBILICAL CORD, NADIDE, SODIUM DIETHYL OXALACETATE,SUS SCROFA PLACENTA,TOXICODENDRON PUBESCENS LEAF, SANGUINARIA CANADENSIS ROOT, SILICON DIOXIDE,SULFUR,CORIANDERBiologische Heilmittel Heeld5d7a2e5-a6ce-4a41-9430-1378023aa7d02023-09-28WarningsExact identifier
unii: N9288CD508
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: N9288CD508
Polyhesion FormulaSANGUINARIA CANADENSIS, NITRICUM ACIDUM, TEUCRIUM MARUM, THUJA OCCIDENTALIS, SANGUINARINUM NITRICUM, CALCAREA CARBONICA, PHOSPHORUSNutritional Specialties, Inc.fb00394c-af0a-4ed0-abf8-c603938f0a252023-09-12WarningsExact identifier
unii: N9288CD508
Cyclease MenopauseARNICA MONTANA WHOLE, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SANGUINARIA CANADENSIS ROOTBoirona227e8d8-27a3-592f-e053-2a95a90ab31c2023-08-16WarningsExact identifier
unii: N9288CD508
unii: K73E24S6X9
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f3bcf-0e45-d390-e063-6394a90a588e2023-07-28WarningsExact identifier
unii: N9288CD508
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f0210-195d-11d7-e063-6294a90aa7502023-07-27WarningsExact identifier
unii: N9288CD508
Cimifuga racemosaBLACK COHOSHBoiron852a9b35-1764-b1c7-e053-2a91aa0a7daf2023-07-20Exact identifier
unii: K73E24S6X9
Endopar FCIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.d186ae0e-0dc3-48e7-9e22-6778bb80ad182023-06-07WarningsExact identifier
unii: K73E24S6X9
Theraworx Nerve Relief FoamONION, HYPERICUM PERFORATUM WHOLE, SANGUINARIA CANADENSIS ROOTAVADIM HOLDINGS, INC.9ed7d5fc-ad84-499b-a774-feedf21ca8d42023-04-25WarningsExact identifier
unii: N9288CD508
Cimicifuga racemosaBLACK COHOSHBoiron72e3e130-7a53-11e6-ba3c-424c583030312023-04-11Exact identifier
unii: K73E24S6X9
Sanguinaria canadensisSANGUINARIA CANADENSIS ROOTBoiron86cecb70-fb10-57b8-e053-2991aa0abd352023-03-27Exact identifier
unii: N9288CD508
Sanguinaria canadensisSANGUINARIA CANADENSIS ROOTBoiron86cef9cc-eb8c-34e8-e053-2a91aa0ab9ae2023-03-27Exact identifier
unii: N9288CD508
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: K73E24S6X9
Cyclease CrampsBLACK COHOSH, CITRULLUS COLOCYNTHIS FRUIT PULP, ESIUM PHOSPHATE, DIBASIC TRIHYDRATELaboratoires Boiron39c20cb2-79c4-4775-b3a9-55cfa67fb7432023-03-06WarningsExact identifier
unii: K73E24S6X9
Walgreens Pain Relieving Foot Pain ReliefAPIS MELLIFERA, GELSEMIUM SEMPERVIRENS WHOLE, AND PSEUDOGNAPHALIUM LUTEOALBUM LEAFWalgreen Company6c6cbae1-e2a9-43bf-9bfc-a20e9d22cc582023-02-27WarningsExact identifier
unii: R0519OZO3K

Reported adverse events (FAERS/openFDA)#

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