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 114 of 246 · 4,918 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FRESH FEELS HAND SANITIZER MIST LAVENDER SCENTETHYL ALCOHOLPearl World Inc.59d76f20-ca26-4cb2-b929-f8ae7c281f3e2025-10-06WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT LIME SCENTETHYL ALCOHOLPearl World Inc.d47930c5-ea4e-43a5-8654-ca4f9d391c2d2025-10-06WarningsExact identifier
unii: 3K9958V90M
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.121eb51a-befe-47ea-85c6-d77e8c7e58642025-10-06WarningsExact identifier
unii: 27YLU75U4W
unii: XF417D3PSL
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA, Inc.b1c8e5d0-a766-4bf0-a385-b7b8940a0e2c2025-10-06WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PEAR SPLASH SCENTETHYL ALCOHOLPearl World Inc.a0df14cd-50a3-48ba-8510-f04276793acc2025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST OCEAN BREEZE SCENTETHYL ALCOHOLPearl World Inc.2d37bdef-2927-4d5c-906d-4f6563524cdd2025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST VANILLA SUGAR SCENTETHYL ALCOHOLPearl World Inc.0c5c7939-b2ba-47b6-bb51-39920e320f952025-10-03WarningsExact identifier
unii: 3K9958V90M
TopricinAESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CROTALUS HORRIDUS, ECHINACEA, GRAPHITES, HELODERMA HORRIDUM, LACHESIS MUTUS, NAJA TRIPUDIANS, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SULFURTopical BioMedics, Inc.321e83de-71e8-20b4-e054-00144ff8d46c2025-10-03WarningsExact identifier
unii: 27YLU75U4W
Virus Defense ANNAKAREACONITUM NAPELLUS ROOT, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA WHOLE, BRYONIA ALBA ROOT, ECHINACEA ANGUSTIFOLIA WHOLE, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS WHOLE, TOXICODENDRON PUBESCENS LEAFRatis, LLC147f3bee-0fbc-472d-aade-90897550b8362025-10-03WarningsExact identifier
unii: T7J046YI2B
FRESH FEELS HAND SANITIZER MIST BLUE RASPBERRY SCENTETHYL ALCOHOLPearl World Inc.fd522416-b585-4426-ac0b-fb363d8ae5922025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST SWEET PEONY SCENTETHYL ALCOHOLPearl World Inc.1fbe93d5-8af2-41ca-b516-98729655d2d42025-10-03WarningsExact identifier
unii: 3K9958V90M
Zylast AntisepticETHYL ALCOHOLInnovative BioDefense178190dc-7c68-6485-e054-00144ff8d46c2025-10-02WarningsExact identifier
unii: 3K9958V90M
CleanBoss Hand Sanitizing GelETHYL ALCOHOLInnovative Biodefensed91c77ae-e9ff-4656-e053-2995a90a16d42025-10-02WarningsExact identifier
unii: 3K9958V90M
CleanBoss Hand SanitizerALCOHOLInnovative Biodefense, Incd91b6278-864e-477a-e053-2a95a90aabd92025-10-02WarningsExact identifier
unii: 3K9958V90M
CleanBoss Hand Sanitizing GelETHYL ALCOHOLInnovative Biodefensed91c5753-eb27-1d1c-e053-2a95a90a888a2025-10-02WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PINEAPPLE SCENTETHYL ALCOHOLPearl World Inc.36853a90-74fa-4427-814a-d703e68a6dde2025-10-01WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST MIXED BERRY SCENTETHYL ALCOHOLPearl World Inc.f48def31-3a9c-49fb-817b-5fca781ad88a2025-10-01WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST STRAWBERRY SCENTETHYL ALCOHOLPearl World Inc.70963fc5-926c-446a-abe6-b828436255db2025-10-01WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COTTON CANDY SCENTETHYL ALCOHOLPearl World Inc.3e77d397-ef6c-4898-8e87-31023b44dc362025-10-01WarningsExact identifier
unii: 3K9958V90M
Xpect Industrial Eye ReliefGLYCERIN, NAPHAZOLINE HCLCintas Corporationa0167d06-7adb-36f4-e053-2a95a90af9ef2025-09-30WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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