NDC 53499-1391-01 - ALPHA SH

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
53499-1391
Requested NDC
53499-1391-01
Package NDCs from labels
53499-1391-1, 53499-1391-01
Manufacturer
Schwabe North America, Inc. | Schwabe Mexico, S.A. de C.V.
Effective date
2022-03-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alpha SHSchwabe North America, Inc. | Schwabe Mexico, S.A. de C.V.2022-03-22HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1391-1ALPHA SH10 in 1 BLISTER PACKTABLET1010
53499-1391-1ALPHA SH4 in 1 BOXTABLET410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-1391ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [SCHWABE NORTH AMERICA, INC.]10Current NDC, Legacy NDC, 2 package rows20220323_94de9ce3-6ee9-4322-bda2-0b4391f09d87.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JVALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD508ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
GOLDENSEALACTIVE MOIETYZW3Z11D0JVALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
POTASSIUM CATIONACTIVE MOIETY295O53K152ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD508ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.]3

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 5 of 86 · 1,712 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM27ARNICA MONT, CROCUS SAT., HAMAMELIS, MILLEFOLIUM, SANGUINARIA, SECALE CORN, TRILLIUM PENDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5448acb4-775a-3d22-e063-6394a90a98bf2026-06-15WarningsExact identifier
unii: N9288CD508
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 660YQ98I10
KALMIAARNICA MONTANA, CHELIDONIUM, COLCHICUM, KALMIA, RANUNCULUS BULB, SANGUINARIA NIT, SUMBULTotal Operations Management LLC DBA:Bestmade Natural Products Micro54396b20-2708-1393-e063-6294a90ad8022026-06-14WarningsExact identifier
unii: N9288CD508
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM96 DROPSAGRAPHIS NUTANS, HYDRASTIS CAN, BARYTA IOD., BARYTA MUR., CALCAREA IOD., CALCAREA PHOS., CISTUS CANBM Private Limited540bc176-74f3-cd39-e063-6294a90a00462026-06-12WarningsExact identifier
unii: ZW3Z11D0JV
BM BM97 DROPSBRYONIA, IPECAC, JUNCUS EFF., KALI MUR, KALI SULPH, PHYTOLACCA DECBM Private Limited540bcbc3-bb31-6ede-e063-6294a90a2bf62026-06-12WarningsExact identifier
unii: 660YQ98I10
BM BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINABM Private Limited540bf4ca-c217-1aa1-e063-6394a90ab6402026-06-12WarningsExact identifier
unii: N9288CD508
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM96 DROPSAGRAPHIS NUTANS, HYDRASTIS CAN, BARYTA IOD., BARYTA MUR., CALCAREA IOD., CALCAREA PHOS., CISTUS CANTotal Operations Management LLC DBA:Bestmade Natural Products Micro5411ad88-bc3a-0563-e063-6294a90a28302026-06-12WarningsExact identifier
unii: ZW3Z11D0JV
Potassium ChloridePOTASSIUM CHLORIDEREMEDYREPACK INC.f75713cf-6902-4160-94cb-335a1ecdbbbe2026-06-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
BM BM97 DROPSBRYONIA, IPECAC, JUNCUS EFF., KALI MUR, KALI SULPH, PHYTOLACCA DECTotal Operations Management LLC DBA:Bestmade Natural Products Micro5411cd7a-381d-ac21-e063-6394a90a5b912026-06-12WarningsExact identifier
unii: 660YQ98I10
BM BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINATotal Operations Management LLC DBA:Bestmade Natural Products Micro5411fb53-7bd2-d904-e063-6294a90a2c582026-06-12WarningsExact identifier
unii: N9288CD508
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLC548953ac-31c5-a181-e063-6294a90a3b772026-06-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCBM Private Limited53e763ee-9a44-a914-e063-6394a90aeb3c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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