FDA.reportPublic FDA data

NDC 53499-0803-05 - Sambucus Flu Relief

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
53499-0803
Requested NDC
53499-0803-05
Package NDCs from labels
53499-0803-5, 53499-0803-05
Manufacturer
Schwabe North America, Inc.
Effective date
2025-12-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sambucus Flu ReliefSchwabe North America, Inc.2025-12-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-0803-5Sambucus Flu Relief1 in 1 BOXSYRUP14
53499-0803-5Sambucus Flu Relief120 mL in 1 BOTTLE, PLASTICSYRUP1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-0803SAMBUCUS FLU RELIEF (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOP ) SYRUP [SCHWABE NORTH AMERICA, INC.]3Current NDC, 2 package rows20240404_ca7d57b0-ffae-415f-a959-b0c88ae7dd40.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 151 of 244 · 4,862 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-16BLACK COHOSH, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT, GELSEMIUM SEMPERVIRENS ROOT, AND SPIGELIA ANTHELMIADNA Labs, Inc.4784ddc2-c308-4092-a01f-ea2b2954a8882025-01-13WarningsExact identifier
unii: 639KR60Q1Q
D-36AMANITA MUSCARIA FRUITING BODY, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, PHOSPHORUS, AND ZINC VALERATE DIHYDRATEDNA Labs, Inc.0c658eda-70eb-4322-ade4-2ec7d7690aeb2025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-12POTASSIUM IODIDE, CALCIUM IODIDE, ARSENIC TRIIODIDE, BARIUM CHLORIDE DIHYDRATE, NITROGLYCERIN, CONIUM MACULATUM FLOWERING TOP, ARNICA MONTANA, PHOSPHORUS, AND GOLD TRICHLORIDEDNA Labs, Inc.cd69e429-32af-4d77-9ec1-c40cfc7fe4142025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-9CUPRIC ACETATE, IPECAC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, DROSERA ROTUNDIFOLIA, ATROPA BELLADONNA, HYOSCYAMUS NIGER, ONION, CORALLIUM RUBRUM EXOSKELETON, AND LOBARIA PULMONARIADNA Labs, Inc.15cb964d-086f-40a6-8056-5f149f04ab4c2025-01-13WarningsExact identifier
unii: 62I3C8233L
D-32NITRIC ACID, ATROPA BELLADONNA, PILOCARPUS JABORANDII WHOLE, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SAMBUCUS NIGRA FLOWERING TOP, SEPIA OFFICINALIS JUICE, SANGUINARIA CANADENSIS ROOT, VERATRUM ALBUM ROOT, AND SAGEDNA Labs, Inc81bb16d9-9c93-48d3-85ca-81c118a1c4a02025-01-13WarningsExact identifier
unii: CT03BSA18U
D-43ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.937e2b7e-4001-402f-bd12-dcff4627e9282025-01-13WarningsExact identifier
unii: T7J046YI2B
D-70ACONITUM NAPELLUS, SIMABA CEDRON SEED, CITRULLUS COLOCYNTHIS FRUIT PULP, KALMIA LATIFOLIA LEAF, AND VERBASCUM THAPSUSDNA Labs, Inc.3f6a830d-3406-4d2b-8673-0e5df9caa3ec2025-01-13WarningsExact identifier
unii: U0NQ8555JD
D-38APIS MELLIFERA, APIS MELLIFERA VENOM, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, AND SULFURDNA Labs, Inc.5fff6e4f-a7a4-4975-a8ad-5a3b4685f4aa2025-01-13WarningsExact identifier
unii: T7J046YI2B
D-41PHOSPHORIC ACID, CHASTE TREE, CINCHONA OFFICINALIS BARK, TURNERA DIFFUSA LEAFY TWIG, PHOSPHORUS, SEPIA OFFICINALIS JUICE, BOS TAURUS TESTICLE, AND CONIUM MACULATUM FLOWERING TOPDNA Labs, Inc.3600d04a-bab5-440a-a2aa-908bf920620a2025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-80BAPTISIA TINCTORIA ROOT, LACHESIS MUTA VENOM, ECHINACEA ANGUSTIFOLIA, BRYONIA ALBA ROOT, ACONITUM NAPELLUS, SOLIDAGO VIRGAUREA FLOWERING TOP, AND AVENA SATIVA FLOWERING TOPDNA Labs, Inc.83e4ab65-514d-47ab-9d99-147168587ab22025-01-13WarningsExact identifier
unii: T7J046YI2B
unii: U0NQ8555JD
D-72APIS MELLIFERA, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, MOMORDICA BALSAMINA IMMATURE FRUIT, AND PHOSPHORUSDNA Labs, Inc.2646ff5c-0c06-456d-903a-df8aeca153162025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-57ARSENIC TRIIODIDE, PHOSPHORUS, TEUCRIUM SCORODONIA FLOWERING TOP, SILICON DIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND LYCOPODIUM CLAVATUM SPOREDNA Labs, Inc.81cc16e7-921b-4b57-abeb-c44b9d72e4f32025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-48PICRIC ACID, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, SOLANUM DULCAMARA WHOLE, POTASSIUM CARBONATE, PHOSPHORUS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, LYCOPODIUM CLAVATUM SPORE, AND FERROSOFERRIC PHOSPHATEDNA Labs, Inc.1d55827f-0ea2-4eda-ae43-7c0723e5708e2025-01-13WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
D-37ALUMINUM OXIDE, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MERCURIC CHLORIDE, STRYCHNOS NUX-VOMICA SEED, LEAD ACETATE ANHYDROUS, AND SULFURDNA Labs, Inc.3b408532-b84b-4398-ab8d-64d5a9c8d0922025-01-13WarningsExact identifier
unii: T7J046YI2B
D-52AETHUSA CYNAPIUM, APOMORPHINE HYDROCHLORIDE, ANAMIRTA COCCULUS SEED, COLCHICUM AUTUMNALE BULB, IPECAC, STRYCHNOS NUX-VOMICA SEED, VERATRUM ALBUM ROOT, AND KEROSENEDNA Labs, Inc.d454b66a-c55c-4082-b7c4-a90f43d2d4422025-01-13WarningsExact identifier
unii: 62I3C8233L
D-54DIBASIC POTASSIUM PHOSPHATE, SEPIA OFFICINALIS JUICE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA, ARSENIC TRIOXIDE, AND SEMECARPUS ANACARDIUM JUICEDNA Labs, Inc.68a206a8-6f66-4957-843c-4c4c0636e78f2025-01-13WarningsExact identifier
unii: 27YLU75U4W
unii: 639KR60Q1Q
D-64CHAMAELIRIUM LUTEUM ROOT, POTASSIUM ARSENITE ANHYDROUS, PHOSPHORUS, LEAD, AND SOLIDAGO VIRGAUREA FLOWERING TOPDNA Labs, Inc.ff5d5ebd-4cfa-45cd-8e27-7012dc44ff882025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-35ACONITUM NAPELLUS, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, STRYCHNOS IGNATII SEED, DELPHINIUM STAPHISAGRIA SEED, AND BRYONIA ALBA ROOTDNA Labs, Inc.275cc8ec-30ed-4dd9-815c-d082ee5b3a992025-01-13WarningsExact identifier
unii: T7J046YI2B
unii: U0NQ8555JD
D-45SILVER NITRATE, ARNICA MONTANA, ARUM MACULATUM ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND PHOSPHORUSDNA Labs, Inc.ef1b1a20-8215-4b63-8f4c-4158c3dec0622025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-104APIUM GRAVEOLENS WHOLE, ASCLEPIAS INCARNATA ROOT, CALCIUM ARSENATE, CAMPHOR (NATURAL), ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, FERROUS IODIDE, ICHTHAMMOL, SCABIES LESION LYSATE (HUMAN), THUJA OCCIDENTALIS LEAFY TWIG, AND TRIFOLIUM REPENS FLOWERDNA Labs, Inc.09c3912a-71ba-4814-8b91-d0e787b542bf2025-01-13WarningsExact identifier
unii: 1W0775VX6E

Reported adverse events (FAERS/openFDA)#

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