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 13 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cimifuga racemosaBLACK COHOSHBoiron852aa8cf-2161-1fdb-e053-2a91aa0a2ba62023-02-20Exact identifier
unii: K73E24S6X9
STOPAIN CLINICAL Migraine and HeadacheMENTHOL, UNSPECIFIED FORM, ATROPA BELLADONNA, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOTTroy Manufacturing, Inc.c5b690ce-7bb6-4840-b00b-205cd5bc6be62023-01-25WarningsExact identifier
unii: N9288CD508
SINUSCALM ALLERGYATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT,Boirone4e0b0b3-df5e-6d47-e053-2a95a90aeba82023-01-18Exact identifier
unii: N9288CD508
UPELVACYCLAMEN PURPURASCENS TUBER, CHAMAELIRIUM LUTEUM ROOT, HYPERICUM PERFORATUM, POTASSIUM CARBONATE, DELPHINIUM STAPHISAGRIA SEED, DATURA STRAMONIUM FLOWERING TOP, VIBURNUM OPULUS BARK, AND ZANTHOXYLUM AMERICANUM BARKPEKANA Naturheilmittel GmbH0eb375d3-a0bb-4592-a2eb-6553f024d78c2023-01-11WarningsExact identifier
unii: G728143D8Q
KLIFEMALETRIS FARINOSA ROOT, GRAPHITE, CHAMAELIRIUM LUTEUM ROOT, PILOCARPUS JABORANDII LEAF, LACHESIS MUTA VENOM, ANEMONE PRATENSIS FLOWERING TOP, SANGUINARIA CANADENSIS ROOT, AND LAMIUM ALBUM FLOWERING TOPPEKANA Naturheilmittel GmbH6193b54f-cb07-43da-a18e-18c123e9179b2023-01-11WarningsExact identifier
unii: N9288CD508
Cimifuga racemosaBLACK COHOSHBoiron852a3251-bf24-5557-e053-2991aa0a4fbd2023-01-05Exact identifier
unii: K73E24S6X9
Sanguinaria CanadensisSANGUINARIA CANADENSISHahnemann Laboratories, INC.f179fdc3-e593-b66e-e053-2995a90a56422023-01-04Exact 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 (2021-2022), SPLEEN (SUIS), THYMUS,Deseret Biologicals, Inc.3c6bb436-0b4f-4f0d-ba03-7963064a5b182022-12-29WarningsExact identifier
unii: N9288CD508
GUNA-ARTHRO.ALPHA.-KETOGLUTARIC ACID - ALPHA LIPOIC ACID - ASCORBIC ACID - BARIUM OXALOSUCCINATE - BLACK COHOSH - BRYONIA ALBA ROOT - CALCITONIN HUMAN - CHLORINE - COLCHICUM AUTUMNALE BULB - NADIDE -Guna spa45ad3f03-0ee8-438f-81e7-3ca772022c982022-11-15WarningsExact identifier
unii: K73E24S6X9
Cimicifuga RacemosaCIMICIFUGA RACEMOSAHahnemann Laboratories, INC.e08eb7fa-7314-63ed-e053-2a95a90a97c62022-06-03Exact identifier
unii: K73E24S6X9
MigraideCYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOTSchwabe North America, Inc.0dc575dd-ef7e-4f91-a2b3-0ea3637a871e2022-03-24WarningsExact identifier
ndc (package): 53499-3391-1
ndc (product): 53499-3391
ndc11 (package): 53499339101
spl id: bc629508-09ed-4ceb-b954-9dbc2c2d07ab
spl set id: 0dc575dd-ef7e-4f91-a2b3-0ea3637a871e
unii: G728143D8Q
unii: R0519OZO3K
unii: N9288CD508
unii: K73E24S6X9
unii: PYC571247P
MigraideCYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOTSchwabe Mexico, S.A. de C.V.f048c3b0-02be-4bf8-b88f-375f9280d6c72022-03-24WarningsExact identifier
unii: G728143D8Q
unii: R0519OZO3K
unii: N9288CD508
unii: K73E24S6X9
unii: PYC571247P
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe Mexico, S.A. de C.V.3e2e5f52-db54-4635-83a8-a67a683c093c2022-03-22WarningsExact identifier
unii: N9288CD508
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe North America, Inc.94de9ce3-6ee9-4322-bda2-0b4391f09d872022-03-22WarningsExact identifier
unii: N9288CD508
Cimicifuga RacemosaCIMICIFUGA RACEMOSAOHM PHARMA INC.46a7bfa2-50a8-41c4-9d64-2d6fd7e604652021-12-30WarningsExact identifier
unii: K73E24S6X9
Stress DropsCIMICIFUGA RACEMOSA, GELSEMIUM, HYPERICUM, STAPHYSAGRIA, IGNATIA AMARA, KALI BROMATUM, KALI PHOSPHORICUM, MOSCHUS, LACHESIS MUTUS, PULSATILLA.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics9b48c4c1-f445-4e83-8944-4809fd8e4f5f2021-12-29WarningsExact identifier
unii: K73E24S6X9
SINUS RXCALCAREA CARB, EUPHORBIUM, HYDRASTIS, KALI BIC, KALI IOD, LYCOPODIUM, PHOSPHORUS, PULSATILLA, THUJA OCC, SANGUINARIAMiami Beach Pediatrics pa078f6bfd-b4ff-4b20-8cff-83b7cd30f1472021-12-29WarningsExact identifier
unii: N9288CD508
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: N9288CD508
OHM MenopauseAMMONIUM CARBONICUM, AMYL NITROSUM, CIMICIFUGA RACEMOSA, GLONOINUM, LACHESIS MUTUS, SANGUINARIA, CANADENSIS.OHM PHARMA INC.08dcc379-6d64-41b8-bf67-cab6031dcf722021-12-29WarningsExact identifier
unii: N9288CD508
unii: K73E24S6X9
MigraideCYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOTSchwabe Mexico, S.A. de C.V.908816fc-2ef3-4120-8e6f-54e8bb1e39ae2021-11-09WarningsExact identifier
unii: G728143D8Q
unii: R0519OZO3K
unii: N9288CD508
unii: K73E24S6X9
unii: PYC571247P

Reported adverse events (FAERS/openFDA)#

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