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 7 of 86 · 1,712 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDERedpharm Drug5261dfe5-d62b-d618-e063-6294a90a96e72026-05-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLCd2e84d34-e042-477f-9944-3fcb953012172026-05-20Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
potassium chloridePOTASSIUM CHLORIDENorthstar Rx LLCb19a3fbf-cdbb-4f86-ac61-5dfb07e0a51a2026-05-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
Vein GardAESCULUS HIPPOCASTANUM, APIS MELLIFICA, CARBO VEGETABILIS, CARDUUS MARIANUS, HAMAMELIS VIRGINIANA, LYCOPODIUM CLAVATUM, PULSATILLA, SEPIANaturalCare76468373-f6f6-43ec-80b2-2816a15f065b2026-05-11WarningsExact identifier
unii: I76KB35JEV
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
FNG IIECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, IODIUM, ADRENALINUM, ARGENTUM METALLICUM, THYMUS (SUIS), THYROIDINUM (SUIS), PHOSPHORICUM ACIDUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SEPIABioActive Nutritional, Inc.d15cbfe9-051d-4aeb-a0f3-105bef7796bc2026-05-07WarningsExact identifier
unii: ZW3Z11D0JV
unii: I76KB35JEV
GastrotoneCAPSICUM ANNUUM, FOENICULUM VULGARE, SYMPHYTUM OFFICINALE, ARGENTUM NITRICUM, ARSENICUM ALBUM, MAGNESIA PHOSPHORICA, PULSATILLA (VULGARIS)BioActive Nutritional, Inc.1ba810f2-ee90-400c-81d7-d066c5eebe592026-05-07WarningsExact identifier
unii: I76KB35JEV
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Triple Flu DefenseACONITUM NAPELLUS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, INFLUENZINUM, IPECACUANHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, SANGUINARIA CANADENSIS, STICTA PULMONARIANenningers Naturals04889636-6e05-4d9c-aaba-194251adfa312026-05-06WarningsExact identifier
unii: N9288CD508
Matrix SupportCEANOTHUS AMERICANUS, ARGENTUM NITRICUM, CONDURANGO, HYDRASTIS CANADENSIS, MOMORDICA BALSAMINA, PULSATILLA (PRATENSIS), BILE DUCT (SUIS), COLON (SUIS), DUODENUM (SUIS), ESOPHAGUS (SUIS), EYE (SUIS), GALLBLADDER (SUIS), ILEUM (SUIS), INTESTINE (SUIS), IPECACUANHA, JEJUNUM (SUIS), KALI BICHROMICUM, LUNG (SUIS), MUCOSA NASALIS SUIS, NATRUM OXALACETICUM, ORAL MUCOSA (SUIS), PANCREAS SUIS, PHOSPHORUS, RECTAL MUCOSA (SUIS), STOMACH (SUIS), SULPHUR, VERATRUM ALBUM, MANNOSE, ANACARDIUM ORIENTALE, KREOSOTUM,Deseret Biologicals, Inc.bae2c721-44e8-4f88-92da-66e8ae03ada02026-05-06WarningsExact identifier
unii: ZW3Z11D0JV
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4
Allergena for PetsHOMEOPATHIC SUBLINGUAL IMMUNOTHERAPYMeditrend, Inc. DBA Progena Professional Formulationsfae97f87-3d3d-4f55-bcf3-9c60ebdc129a2026-04-30WarningsExact identifier
unii: ZW3Z11D0JV
Snore Stop OralSprayATROPA BELLADONNA, EPHEDRA DISTACHYA FLOWERING TWIG, HISTAMINE, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX VOMICA SEED, TEUCRIUM MARUMGreen Pharmaceuticals544dda7f-c748-eda7-e063-6394a90ab0912026-04-30WarningsExact identifier
unii: ZW3Z11D0JV
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lymph DrainageBAPTISIA TINCTORIA, CITRUS LIMONUM, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, TEUCRIUM SCORODONIA, THUJA OCCIDENTALIS, CAPSICUM ANNUUM, CUPRUM SULPHURICUM, KALI MURIATICUM, MANGANUM MURIATICUM, ARSENICUM IODATUM, CARPINUS BETULUS, FLOS, CENTAURIUM UMBELLATUM, FLOS, GALIUM APARINE, LARIX DECIDUA, FLOS, ROSA CANINA, SCROPHULARIA NODOSA, ZINCUM GLUCONICUM, ARANEA DIADEMA, CALCAREA CARBONICA, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, LACHESIS MUTUSCarnivora Research International57be5edd-a45b-40e4-b095-fafbfd3dc7032026-04-20WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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