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 11 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: N9288CD508
Immune SupportECHINACEA (ANGUSTIFOLIA), ARNICA MONTANA, BAPTISIA TINCTORIA, SANGUINARIA CANADENSIS, ARISTOLOCHIA CLEMATITIS, EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINARUM, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, MERCURIUS CORROSIVUS, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), RHUS TOX, SULPHUR, THUJA OCCIDENTALIS, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, ZINCUM METALLICUM, ASTRAGALUS MEMBRANACEUS, INFLUENZINUM (2022-2023), SPLEEN (SUIS), THYMUS,Deseret Biologicals, Inc.55e12503-4782-424a-8661-6107aa9838e22024-02-29WarningsExact identifier
unii: N9288CD508
MenotoneANGELICA ARCHANGELICA, CIMICIFUGA RACEMOSA, BELLADONNA, LACHESIS MUTUS, PULSATILLA (PRATENSIS), SABINA, SANGUINARIA CANADENSIS, SEPIA, SULPHUREnergique, Inc.0921be57-44b4-4d1c-a50a-7886fc807d002024-01-23WarningsExact identifier
unii: N9288CD508
unii: K73E24S6X9
A09 FEMALE BALANCEARGENTUM NITRICUM, ATROPINUM SULPHURICUM, AURUM MURIATICUM NATRONATUM, BOS TAURUS OVARY, BOS TAURUS PANCREAS, BOS TAURUS PITUITARUM POSTERIUM, BOS TAURUS UTERUS, CIMICIFUGA RACEMOSA, ESTRONE, HELONIAS DIOICA, PROGESTERONE, PULSATILLA VULGARIS, SABINA, SEPIA, SEQUOIADENDRON GIGANTEUM WHOLE, SUS SCROFA PINEAL GLAND, SUS SCROFA SPLEEN, THIOSINAMINUM, THYROIDINUM, VIBURNUM OPULUSApex Energetics Inc.b8e1ba2a-f80f-158e-e053-2a95a90aacd12024-01-08WarningsExact identifier
unii: K73E24S6X9
F22 SOMATICAAGRIMONY, CALOCHORTUS TOLMIEI, CIMICIFUGA RACEMOSA, CLEMATIS VITALBA, DANDELION, DIPLACUS AURANTIACUS, ECHINACEA ANGUSTIFOLIA, EHRENDORFERIA CHRYSANTHA, FUCHSIA, HYDRASTIS CANADENSIS, KALI PHOSPHORICUM, LARIX DECIDUA, LATHYRUS ODORATUS, LONICERA CAPRIFOLIUM, NATRUM MURIATICUM, ROSA CALIFORNICA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR, YARROW, YERBA SANTAApex Energetics Inc.bed99bed-3902-5278-e053-2a95a90aeab62024-01-08WarningsExact identifier
unii: K73E24S6X9
MYCCombinationALLIUM CEPA, ECHINACEA (ECHINACEA ANGUSTIFOLIA), NATRUM SULPHURICUM, KALI CARBONICUM, MEPHITIS MEPHITICA, SANGUINARIA CANADENSIS, BLATTA ORIENTALIS, AGARICUS MUSCARIUS, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, PHYTOLACCA DECANDRA, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALIS, AMMONIUM CARBONICUM, ASPERGILLUS NIGERDeseret Biologicals, Inc.795c34c6-71c8-4c36-b441-4bca55a435752023-12-04WarningsExact identifier
unii: N9288CD508
Sanguinaria canadensisSANGUINARIA CANADENSIS ROOTBoiron86cead9a-cae9-751e-e053-2a91aa0a1a502023-11-14Exact identifier
unii: N9288CD508
Sanguinaria canadensisSANGUINARIA CANADENSIS ROOTBoiron86cef6f7-4f31-bb3a-e053-2991aa0aa9712023-11-14Exact identifier
unii: N9288CD508
Sanguinaria canadensisSANGUINARIA CANADENSIS ROOTBoiron86cefd91-771d-e4e7-e053-2991aa0a655e2023-11-14Exact identifier
unii: N9288CD508
Sanguinaria canadensisSANGUINARIA CANADENSIS ROOTBoiron67bf4390-7c73-11e6-8955-424c583030312023-11-14Exact identifier
unii: N9288CD508
Cyclamen europaeumCYCLAMEN PURPURASCENS TUBERBoiron87364c2a-06f0-b282-e053-2991aa0a2db82023-11-13Exact identifier
unii: G728143D8Q
Cyclamen europaeumCYCLAMEN PURPURASCENS TUBERBoiron857af137-7a3c-2413-e053-2a91aa0a46472023-11-13Exact identifier
unii: G728143D8Q
Cyclamen europaeumCYCLAMEN PURPURASCENS TUBERBoiron857ab9e4-898e-dbde-e053-2a91aa0a2c142023-11-13Exact identifier
unii: G728143D8Q
Cyclamen europaeumCYCLAMEN PURPURASCENS TUBERBoiron857a8da9-5158-33a3-e053-2991aa0a133d2023-11-13Exact identifier
unii: G728143D8Q
Cyclamen europaeumCYCLAMEN PURPURASCENS TUBERBoiron857aa236-71b9-b33e-e053-2991aa0aea232023-11-13Exact identifier
unii: G728143D8Q
Cimifuga racemosaBLACK COHOSHBoiron852a6651-24bf-2c72-e053-2a91aa0a838b2023-11-09Exact identifier
unii: K73E24S6X9
Cimifuga racemosaBLACK COHOSHBoiron852a47e0-e9de-ae5e-e053-2991aa0a030b2023-11-09Exact identifier
unii: K73E24S6X9
Cimifuga racemosaBLACK COHOSHBoiron852a3251-bf29-5557-e053-2991aa0a4fbd2023-11-09Exact identifier
unii: K73E24S6X9
Cimifuga racemosaBLACK COHOSHBoiron852acb2d-8cf8-1c86-e053-2a91aa0a13e92023-11-09Exact identifier
unii: K73E24S6X9
Cimifuga racemosaBLACK COHOSHBoiron8529e7f1-0c8e-ab5d-e053-2991aa0ab4122023-11-09Exact identifier
unii: K73E24S6X9

Reported adverse events (FAERS/openFDA)#

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