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 152 of 244 · 4,862 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-71ACONITUM NAPELLUS, ARSENIC TRIOXIDE, CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.478668a3-bf20-4205-a81a-2f9e4565f8762025-01-13WarningsExact identifier
unii: U0NQ8555JD
D-102GARLIC, ALOE, MYCOBACTERIUM TUBERCULOSIS, EUCALYPTUS GLOBULUS LEAF, CANIS LUPUS FAMILIARIS MILK, COW MILK, RANCID BEEF, DELPHINIUM STAPHISAGRIA SEED, STAPHYLOCOCCUS EPIDERMIDIS, STAPHYLOCOCCUS HAEMOLYTICUS, STAPHYLOCOCCUS SIMULANS, STREPTOCOCCUS PYOGENES, AND SULFURDNA Labs, Inc.d64022f6-e3e1-459b-b896-843c2a92d9da2025-01-13WarningsExact identifier
unii: S546YLW6E6
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: U0NQ8555JD
D-73SULFURIC ACID, SILVER, ARNICA MONTANA, BRYONIA ALBA ROOT, CAUSTICUM, AND RHODODENDRON TOMENTOSUM LEAFY TWIGDNA Labs, Inc.46fe6da9-404b-4f73-8fe8-c48c5e028ffe2025-01-13WarningsExact identifier
unii: T7J046YI2B
D-110ARNICA MONTANA, HYPERICUM PERFORATUM, PHOSPHORUS, RANCID BEEF, RUTA GRAVEOLENS FLOWERING TOP, FERROSOFERRIC PHOSPHATE, LACHESIS MUTA VENOM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, AND CALENDULA OFFICINALIS FLOWERING TOPDNA Labs, Inc.780ec514-9e36-4a4c-b947-960888fa7c752025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-154ANAMIRTA COCCULUS, ARABICA COFFEE BEAN, ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITE, NUX VOMICA, PHOSPHORUS, POTASSIUM CARBONATE, SULFURDNA Labsf53e05de-043c-4eb4-e053-2995a90ad9cf2025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-152ARSENIC TRIOXIDE, STRYCHNOS NUX-VOMICA SEED, ACONITUM NAPELLUS, GOLD, CAUSTICUM, HYOSCYAMUS NIGER LEAF, LACHESIS MUTA WHOLE, DAPHNE MEZEREUM WHOLE, ANEMONE PULSATILLA, SULFUR, AND VERATRUM VIRIDE WHOLEDNA Labs, Inc.e8968153-24c0-474d-8f4d-493481f442062025-01-13WarningsExact identifier
unii: U0NQ8555JD
D-155ARSENICUM ALBUM, CARBO VEGETABILIS, IPECACUANHA, NUX VOMICA, SULFURDNA Labsf5512f34-08f0-b0f6-e053-2a95a90ab5bd2025-01-13WarningsExact identifier
unii: 62I3C8233L
D-139ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, CARBO VEGETABILIS, FERRUM PHOSPHORICUM, LYCOPODIUM, NATRUM PHOSPHORICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, HYDRASTISDNA Labs, Inc.e830774e-35c8-7309-e053-2995a90ae0432025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-153JUGLANS REGIA LEAF, LACHESIS, CALCAREA CARBONICA, LYCOPODIUM, PHOSPHORUS, MAGNESIUM PHOSPHATEDNA Labsf473b88f-527c-46be-e053-2995a90a73002025-01-13WarningsExact identifier
unii: 27YLU75U4W
SaniiSwabETHYL ALCOHOLPOLLEY MED LLC2ad08239-18ea-9ec9-e063-6394a90a3a542025-01-10WarningsExact identifier
unii: 3K9958V90M
AntibacterialALCOHOLHenry Schein Inc.87446203-1365-49b6-9346-62fb8ec783112025-01-10WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLHenry Schein, Inc.e80feb63-2c51-4164-806d-778e39e620e82025-01-10WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLHenry Schein, Inc.3b075cdc-509d-4259-99a2-0e219998949d2025-01-10WarningsExact identifier
unii: 3K9958V90M
Hand Guard Foaming Alcohol Instant Hand SanitizerALCOHOLWechem, Inc.2b60cd24-f0a9-5c54-e063-6394a90ab3502025-01-10WarningsExact identifier
unii: 3K9958V90M
Sambucus Cold Flu Relief ElderberryPELARGONIUM SIDOIDES ROOT, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA FLOWERING TOP, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECACSchwabe North America, Inc.5de8a3db-6103-4b69-8e47-c78bc7c6bfcd2025-01-10WarningsExact identifier
unii: 27YLU75U4W
unii: 639KR60Q1Q
unii: 62I3C8233L
unii: T7J046YI2B
unii: U0NQ8555JD
unii: CT03BSA18U
unii: 1W0775VX6E
unii: S546YLW6E6
ChemStation E3 Hand SanitizerETHANOLChemstation4a37ef06-b74b-1ed1-e054-00144ff8d46c2025-01-09WarningsExact identifier
unii: 3K9958V90M
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: XF417D3PSL
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a01c5f5-e9d9-5ac1-e053-2995a90a137e2025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a01ab86-eed0-5f1d-e053-2a95a90aff562025-01-09Exact identifier
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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