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 91 of 246 · 4,918 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safeguard Hand SanitizerALCOHOLThe Procter & Gamble Manufacturing Company8ed8ec4c-6b9c-4441-a1f1-de8b72cd8d7a2025-12-18WarningsExact identifier
unii: 3K9958V90M
LemonGLYCERINTwinMed LLCfc88eec0-c66c-5d6d-e053-6294a90a13d22025-12-18WarningsExact identifier
unii: PDC6A3C0OX
Tiny Tot Cough SyrupSQUILLA, ANTIMONIUM TART, ARSENICUM ALB, BELLADONNA, BRYONIA, CHAMOMILLA, CUPRUM MET, DROSERA, HEPAR SULPH CALC, IPECACUANHA, KALI BIC, KALI CARB, PHOSPHORUS, PULSATILLA, SPONGIANatural Creations, Inc38cc6bfc-c59f-4df1-9cff-10b3673b475a2025-12-18WarningsExact identifier
unii: 27YLU75U4W
unii: 62I3C8233L
unii: T7J046YI2B
VIRAL HPARSENIC TRIOXIDE, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, LYCOPODIUM CLAVATUM SPORE, PHOSPHORIC ACID, PHOSPHORUS, RANCID BEEF, TOXICODENDRON PUBESCENS LEAFNatural Creations, Inc.95902493-0881-4a72-be53-2916648627cd2025-12-18WarningsExact identifier
unii: 27YLU75U4W
unii: 639KR60Q1Q
unii: 1W0775VX6E
Party ReliefARSENICUM ALB, AVENA, BRYONIA, CAPSICUM, CARBO AN, CARDUUS MAR, CHELIDONIUM MAJ, HEPAR SUIS, KALI IOD, LAPIS, RADIUM BROM, TARAXACUM, THUJA OCCEight and Company L.L.Cefadeae2-1ed9-4e80-9909-908bde98965b2025-12-18WarningsExact identifier
unii: T7J046YI2B
VIROSODEECHINACEA ANGUSTIFOLIA, HYDRASTIS CANADENSIS, LOMATIUM, PHYTOLACCA DECANDRA, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CARCINOSIN, COXSACKIE, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, HERPES ZOSTER, INFLUENZINUM, MORBILLINUM, PERTUSSIN, PYROGENIUMNatural Creations, Inc80b40e26-ce13-4027-bebc-c4bd6014e3ad2025-12-18WarningsExact identifier
unii: 639KR60Q1Q
unii: U0NQ8555JD
unii: 1W0775VX6E
B-Pure Moisturizing Hand Sanitizer Sugar Pistachio ScentedALCOHOLFourstar Group USA, Inc.b80c402e-ecef-42fe-8cf5-7aa26254a3fe2025-12-17WarningsExact identifier
unii: 3K9958V90M
Bacteria-ChordAZADIRACHTA, BELLADONNA, BERBER VULG, BOLDO, CANDIDA ALB, CEANOTHUS, CETRARIA, CROTALUS HOR , ECHINACEA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA, HAMAMELIS, HEPAR SUIS, HYDRASTIS, HYDROCOTYLE, HYPERICUM, LAPPA, LEDUM, MILLEFOLIUM, MORBILLINUM, MYRRHA, PANCREAS, PERTUSSINUM, PHOS, PLANTAGO, PYROGENIUM, SOLIDAGO, ZINGIBEREnergetix Corporation78c680c9-70bf-4df3-8a82-802f203c3da42025-12-17WarningsExact identifier
unii: 27YLU75U4W
AshleyBelle Moisturizing Hand Sanitizer Black RaspberryETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462ab5e8-029a-fe9d-e063-6294a90ac14d2025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Clementine BurstETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462ad5ba-253f-2a30-e063-6294a90a261d2025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Honeydew TartETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462af072-6709-546f-e063-6294a90aacc82025-12-17WarningsExact identifier
unii: 3K9958V90M
CirculopathADENOSINUM CYCLOPHOSPHORICUM, ARNICA MONTANA, AURUM MURIATICUM, BARYTA MURIATICA, BORAGO OFFICINALIS, CHOLESTERINUM, CITRUS LIMONUM, HYPOTHALAMUS (BOVINE), KALI IODATUM, LAUROCERASUS, MAGNESIA MURIATICA, NADIDUM, PHASEOLUS, PHOSPHORUS, THYROIDINUM (BOVINE)Energetix Corporation448d5ea0-ca41-487a-8321-38b1667764bd2025-12-17WarningsExact identifier
unii: 27YLU75U4W
AshleyBelle Moisturizing Hand Sanitizer Pear BlossomETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b1d38-c7fa-992f-e063-6294a90ab78f2025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Black RaspberryETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b2d3f-67b0-c393-e063-6294a90a208a2025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Clementine BurstETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b36d0-0a1f-bda8-e063-6294a90a57922025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Honeydew TartETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b39e9-cf8e-3268-e063-6394a90a69c02025-12-17WarningsExact identifier
unii: 3K9958V90M
HZ-ChordBAPTISIA TINCTORIA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MEZEREUM, MORBILLINUM, NUX VOMICA, PALOONDO, PHYTOLACCA DECANDRA, SEPIA, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Energetix Corporation9685aec5-a65d-40fe-b5d7-2f13a69733bc2025-12-17WarningsExact identifier
unii: 639KR60Q1Q
unii: XF417D3PSL
AshleyBelle Moisturizing Hand Sanitizer Pear BlossomETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462a1437-154c-0324-e063-6294a90a12662025-12-17WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLSolupharm Pharmazeutische Erzeugnisse GmbH372d3eb5-78ee-414c-a146-4a19e22661842025-12-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Walgreens Black Elderberry Cold and Flu ReliefBRYONIA ALBA, GELSEMIUM SEMPERVIRENS, SAMBUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUMWalgreen Co.d66d2e55-b76b-f88c-e053-2995a90a6e132025-12-17WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: CT03BSA18U

Reported adverse events (FAERS/openFDA)#

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