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 89 of 246 · 4,918 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FRESH FEELS HAND SANITIZER MIST VANILLA BREEZE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited82d9ae31-d6bc-4c74-8add-c4a2a4902c2a2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST MINT CHOCOLATE CHIP ICE Cream SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedfa471391-2023-4b3a-b8f5-114dd93f9fe32025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST SEASHELL SUNSHINE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited04952291-f74a-4a3b-8d7c-12f83593496d2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BEACH COCONUT SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedccecaff5-8bd5-490e-8c73-a06991fa754e2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST STRAWBERRY SHORTCAKE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited8c7fda8c-720f-413b-a4f5-cd8e9169ed6d2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST LYCHEE PEACHY SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited9c62c74e-c69a-4fcf-8f4c-ec03a0bbf0272025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PAPAYA SUNSET SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitede998c88b-5a23-42e8-bdc1-6591ee62fb852025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PINK GUAVA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited2a6f551b-2e2a-4788-b522-c1c7654491172025-12-24WarningsExact identifier
unii: 3K9958V90M
MG DermaGel 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.56ac723b-3ede-4c94-bf4a-0572a7b42b592025-12-23WarningsExact identifier
unii: 3K9958V90M
MG FoamSan 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.11fc23dd-80e1-4df1-8c19-f759ecb34f1a2025-12-23WarningsExact identifier
unii: 3K9958V90M
TazzaETHANOLTazza Brands East Inc.391cc18f-ce63-5d88-e054-00144ff88e882025-12-23WarningsExact identifier
unii: 3K9958V90M
StellaLife VEGA Oral Care CoconutRISNEStellaLife, Inc.b8694e38-dc05-77c9-e053-2995a90a36e42025-12-23WarningsExact identifier
unii: 27YLU75U4W
MG DermaGel 62 LVETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.437a508d-31ba-49b4-b821-4bf57b596e332025-12-23WarningsExact identifier
unii: 3K9958V90M
Alcare Plus Foamed Antiseptic HandrubALCOHOLSC Johnson Professional USA, Inc.56900a58-b586-41e5-8b66-c9a006a79a9b2025-12-22WarningsExact identifier
unii: 3K9958V90M
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINHanlim46851e7c-8910-6456-e063-6394a90abafb2025-12-22WarningsExact identifier
unii: PDC6A3C0OX
Viru-ChordBELLADONNA, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HEPAR SUIS, HYDRASTIS CANADENSIS, ILLICIUM ANISATUM, INFLUENZINUM, LACHESIS MUTUS, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MORBILLINUM, MYRRHA, NASTURTIUM AQUATICUM, NUX VOMICA, PALOONDO, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SAMBUCUS NIGRA, SCUTELLARIA LATERIFLORA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE)Energetix Corporation4a53b25e-f514-4d2d-8c2b-3c56d68ec7eb2025-12-22WarningsExact identifier
unii: 639KR60Q1Q
unii: CT03BSA18U
StellaLife VEGA Oral Care Coconut Advanced Healing FormulaAZADIRACHTA INDICA, APIS MELLIFICA, CALENDULA, ECHINACEA PURPUREA, OKOUBAKA AUBREVILLEI, PHOSPHOROUS, PLANTAGO MAJOR, STRONTIUM, THUJA OCCIDENTALISStellaLife, Inc.10f6cd02-f80d-f597-e063-6294a90a09aa2025-12-22WarningsExact identifier
unii: 27YLU75U4W
Hand Sanitizer Pear Blossom TeaALCOHOL SOLUTIONNoshinku46927edb-f8be-f0b9-e063-6294a90a8e562025-12-22WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Santal BlancALCOHOL SOLUTIONNoshinku4692c807-268e-6477-e063-6394a90aac0a2025-12-22WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Vanilla CremeALCOHOL SOLUTIONNoshinku4692e68c-2bc8-83f8-e063-6294a90a84e42025-12-22WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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