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 92 of 246 · 4,918 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediatric Earache RemedyEAR DROPSVitality Works, Inc5769ce2c-d2e1-4069-92cc-e38bee668daf2025-12-17WarningsExact identifier
unii: U0NQ8555JD
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
Cal-5-ReviveCALCIUM BALANCEVitality Works, Inc.a642c238-dacc-41a0-8590-ca466eb297892025-12-17WarningsExact identifier
unii: 62I3C8233L
unii: U0NQ8555JD
Lung-RespCOUGH RELIEFVitality Works, Incdaa3c047-01da-49c8-9ac0-49e457b48eef2025-12-17WarningsExact identifier
unii: 62I3C8233L
CL-NEMOTIONAL HEALTH BOOSTERVitality Works, Inc.0de1e383-f721-4d2c-a1e1-946371234b882025-12-17WarningsExact identifier
unii: U0NQ8555JD
unii: 1W0775VX6E
Category VIMMUNE SYSTEM BOOSTERVitality Works, Inc,0d3dd923-336c-4ccd-a344-ec49b2e80d102025-12-17WarningsExact identifier
unii: XF417D3PSL
Brain SuppBRAIN SUPPORTVitality Works, Inc.4be3d5f8-f974-4ed6-ba90-f0ce08a600fe2025-12-17WarningsExact identifier
unii: 27YLU75U4W
L-TransLYMPH SYSTEM BOOSTERVitality Works, Inc.72ccb9be-2d62-414a-856a-7fcea51f26d22025-12-17WarningsExact identifier
unii: 1W0775VX6E
Earache RemedyEAR DROPSVitality Works, Inc.49afb2c3-ee42-4be9-943a-36d73ded00042025-12-17WarningsExact identifier
unii: U0NQ8555JD
RPT-SysEMOTIONAL REBALANCEVitality Works, Inc.0e8768fe-c2ba-41e9-93ac-c142fae6e8792025-12-17WarningsExact identifier
unii: S546YLW6E6
RadDefense 2RADDEFENSE2Vitality Works, Inc.2d796691-adc5-52b3-e054-00144ff8d46c2025-12-17WarningsExact identifier
unii: 1W0775VX6E
Sore Muscle and Joint ReliefMUSCLE AND JOINT REMEDYVitaltiy Works, Inc.3cd12d22-0fae-4a00-b026-c574e80352782025-12-17WarningsExact identifier
unii: T7J046YI2B
Kay Hand Sanitizer FoamETHYL ALCOHOLEcolab Inc.f82eaaaf-cead-497a-8b95-9668310511872025-12-17WarningsExact identifier
unii: 3K9958V90M
Keystone Liquid Hand SanitizerALCOHOLEcolab Inc.1d808912-f1ad-4eed-a52d-6c6a363ddba22025-12-16WarningsExact identifier
unii: 3K9958V90M
StressARALIA QUIN, PASSIFLORA, SCUTELLARIA, VALERIANA, ARSENICUM ALB, AUR MET, CALC CARB, COFFEA CRUDA, IGNATIA, KALI PHOS, LYCOPUS, PHOSPHORUS, STAPHYSAGRIANatural Creations, Inccc457f87-16c5-4a52-a234-41a12989916b2025-12-16WarningsExact identifier
unii: 27YLU75U4W
LYCOPODIUM HPAMANITA MUSCARIA FRUITING BODY, ONION, ARNICA MONTANA, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, PHOSPHORUS, LEADNatural Creations, Inc3f477ed2-1e5e-480e-9cde-121d32c4d0752025-12-16WarningsExact identifier
unii: 27YLU75U4W
Mold AntigenALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCCNatural Creations, Inc9dd6f22e-45b0-4771-80f7-6f530c96350d2025-12-16WarningsExact identifier
unii: 27YLU75U4W
NAUSEA VOMITING HPARSENIC TRIOXIDE, ANAMIRTA COCCULUS SEED, IPECA, WOOD CREASOTE, KEROSENE, PULSATILLA VULGARIS, SANGUINARIA CANDENSIS ROOT, TOBACCO LEAFNatural Creations, Inc.5f5b3d53-bfd8-4f74-8ee5-8b8b35f7f97e2025-12-16WarningsExact identifier
unii: 62I3C8233L
Sleepy Time CPACONITUM, ARSENICUM ALB, CALC CARB, COFFEA CRUDA, MAGNESIUM MET, NUX VOM, PULSATILLA, SEPIA, SULPHURNatural Creations, Inc03cbb408-7e2a-49e8-b83a-b8d932a104592025-12-16WarningsExact identifier
unii: U0NQ8555JD
INJURY HPARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHOSPHORUS, RANCID BEEF, SILICON DIOXIDE, DELPHINIUM STAPHISAGRIA SEED, COMFREY ROOTNatural Creations, Inc.10be3e95-da2f-4340-8c12-2e676472a94d2025-12-16WarningsExact identifier
unii: 27YLU75U4W

Reported adverse events (FAERS/openFDA)#

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