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 3 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KALMIAARNICA MONTANA, CHELIDONIUM, COLCHICUM, KALMIA, RANUNCULUS BULB, SANGUINARIA NIT, SUMBULBM Private Limited3b3c955d-453e-28e2-e063-6394a90a6bf92026-02-15WarningsExact identifier
unii: N9288CD508
SinusCalmATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA WHOLEBoiron4ae58d81-3952-b372-e063-6394a90a84992026-02-15WarningsExact identifier
unii: N9288CD508
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: K73E24S6X9
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: K73E24S6X9
NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESSTOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESSBioLyte Laboratories, LLC46da3f0e-9dd1-6495-e054-00144ff8d46c2026-01-27WarningsExact identifier
unii: K73E24S6X9
NeoRelief for Menstrual Pain and CrampsHOMEOPATHIC PAIN RELIEF GELBioLyte Laboratories, LLC71c2a2f7-4823-51cb-e053-2995a90a5fb82026-01-27WarningsExact identifier
unii: G728143D8Q
unii: K73E24S6X9
NEORELIEF FOR PAINTOPICAL GEL FOR PAINBioLyte Laboratories, LLC46df076d-4e3a-6faa-e054-00144ff8d46c2026-01-27WarningsExact identifier
unii: K73E24S6X9
ContessaALCHEMILLA VULGARIS, ASPERULA ODORATA, CHAMOMILLA, VIOLA ODORATA, CINCHONA OFFICINALIS, MENTHA PIPERITA, ROSMARINUS OFFICINALIS, VALERIANA OFFICINALIS, HELONIA DIOICA, AGNUS CASTUS, AMBRA GRISEA, CIMICIFUGA RACEMOSA, CONVALLARIA MAJALIS, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, DAMIANA, HYDRASTIS CANADENSIS, CAULOPHYLLUM THALICTROIDES, LILIUM TIGRINUM, SENECIO AUREUS, STAPHYSAGRIA, NAJA TRIPUDIANSMarco Pharma International LLC.5a8ae10c-87a4-4751-9885-d84b0cad574a2026-01-26WarningsExact identifier
unii: G728143D8Q
unii: K73E24S6X9
Pollen DistressALLIUM CEPA, APIS MELLIFICA, ARALIA RACEMOSA, ARUNDO MAURITANICA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SABADILLA, SANGUINARIA CANADENSIS, URTICA URENSLiddell Laboratories, Inc.034fcd90-81f7-4597-b58b-e2ed7047f6bd2026-01-26WarningsExact identifier
unii: N9288CD508
Bealions EstrogenSOY ISOFLAVONESGuangdong Yucheng Cosmetics Co., Ltd483f6b07-ba71-9089-e063-6294a90a71692026-01-13WarningsExact identifier
unii: K73E24S6X9
Headache ReliefATROPA BELLADONNA, CYCLAMEN PURPURASCENS TUBER, COFFEA ARABICA SEED, ROASTED, IRIS VERSICOLOR ROOT, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, SPIGELIA MARILANDICA ROOT, VIBURNUM OPULUS BARKHomeocare Laboratories47f7bcbc-f4be-4cf0-a5b0-b8d5ca8d852f2026-01-12WarningsExact identifier
unii: G728143D8Q
unii: N9288CD508
Menopause ReliefBARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDEHomeocare Laboratories99b182d5-4102-4b25-85d3-f4be077d753f2026-01-12WarningsExact identifier
unii: K73E24S6X9
Lachesis Combination 9229LACHESIS COMBINATIONProfessional Complementary Health Formulas7301c44c-2460-43ad-9cb2-dffdc8ee423c2026-01-08WarningsExact identifier
unii: N9288CD508
Organophosphate Combination 9309ORGANOPHOSPHATE COMBINATIONProfessional Complementary Health Formulasf777015f-1df6-4821-af63-543175313aba2026-01-08WarningsExact identifier
unii: K73E24S6X9
Ovarian Drops 5017OVARIAN DROPSProfessional Complementary Health Formulas28d864d6-6fb5-4771-bcdd-db9b68403eb32026-01-08WarningsExact identifier
unii: K73E24S6X9
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: N9288CD508
Menopause Drops 2044MENOPAUSE DROPSProfessional Complementary Health Formulas9fe1be78-dc5a-4dd7-9961-33ccfa5a0aa82026-01-08WarningsExact identifier
unii: N9288CD508
unii: K73E24S6X9
PMS Drops 2124PMS DROPSProfessional Complementary Health Formulasd05bfbbe-d19d-4fd5-8679-bf17d0b618402026-01-08WarningsExact identifier
unii: K73E24S6X9
Difficulty Breathing Drops 2171DIFFICULTY BREATHING DROPSProfessional Complementary Health Formulas30bab475-47dd-4261-b497-1f8edf9dd4112026-01-08WarningsExact identifier
unii: K73E24S6X9
Pituitary Liquescence 3018PITUITARY LIQUESCENCEProfessional Complementary Health Formulasa32e9ea9-5ff9-4951-9244-7b3253456b5f2026-01-08WarningsExact identifier
unii: K73E24S6X9

Reported adverse events (FAERS/openFDA)#

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