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 93 of 246 · 4,918 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
InjuryCALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA ALBA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, STAPHYSAGRIA, PYROGENIUMNatural Creations, Incb4b850fb-6fdd-47b7-8a6e-2e596ec6256c2025-12-16WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
PanacodeSYZYGIUM, HYDRASTIS, ADRENALINUM, PANCREATINUM, PITUITARUM POSTERIUM, BOVISTA, INSULIN, LYCOPERSICUM, PHOSPHORICUM AC, PHOSPHORUS, TARENTULA HISPANA, TEREBINTHINA, URANIUM NITRICUMNatural Creations, Incf2144c14-28a2-4dc4-b517-0f81e9c8b7202025-12-16WarningsExact identifier
unii: 27YLU75U4W
SINUS HPAMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIGNatural Creations, Inc.f017da22-74c2-40f4-adcc-5e84b6ea52912025-12-16WarningsExact identifier
unii: 27YLU75U4W
RespirasodeBRYONIA, DULCAMARA, KALI CARB, SANGUINARIA, BELLADONNA, BROMIUM, CANDIDA ALB, CANDIDA PARAP, CONIUM, LYCOPODIUM, PULSATILLA, SECALE, SILICEA, STICTA, SULPHUR, USTILAGO MAIDISNatural Creations, Incce06327f-7e5e-420a-9b61-0d410f9e10d62025-12-16WarningsExact identifier
unii: T7J046YI2B
EcolabALCOHOLEcolab Inc.69962e54-2e1f-404a-b039-5ebf77cabd5f2025-12-16WarningsExact identifier
unii: 3K9958V90M
PS-2362 Hand Sanitizer 0.9g packetPS-2362 HAND SANITIZER 0.9G PACKETProStat First Aid LLC01c87dff-57e0-017a-e063-6394a90a16002025-12-15WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERProstat First Aid LLC0e241343-db64-3f1c-e063-6394a90ab5382025-12-15WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERProStat First Aid LLC0e21f466-d6ed-79c4-e063-6394a90ae9882025-12-15WarningsExact identifier
unii: 3K9958V90M
Fibromyalgia ReliefBRYONIA ALBA ROOT - CAUSTICUM - LOESELIA MEXICANA WHOLE - MAGNESIUM PHOSPHATE - PULSATILLA VULGARIS - TOXICODENDRON PUBESCENS LEAF - VALERIANTRP Companya6ba3058-ec39-715f-e053-2995a90aa32a2025-12-15WarningsExact identifier
unii: T7J046YI2B
Free to BreatheCALENDULA, EUCALYPTUS,PEPPERMINTSpry Life LLC8d437d62-2cbc-5b17-e053-2a95a90ad5cb2025-12-15WarningsExact identifier
unii: S546YLW6E6
Migraine Headache TherapyATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE -TRP Company317d3f42-783e-02b7-e054-00144ff88e882025-12-15WarningsExact identifier
unii: T7J046YI2B
ComPare2 Black Elderberry Cold and Flu ReliefBRYONIA, GELSEMIUM SEMPERVIRENS, SAMBUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUMTRP COMPANYa6231fe1-1f0f-04c8-e053-2a95a90a6ee72025-12-15WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: CT03BSA18U
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: PDC6A3C0OX
Irritable Bowel Syndrome TherapyASAFETIDA - BISMUTH SUBNITRATE - BRYONIA ALBA ROOT - ACTIVATED CHARCOAL - LYCOPODIUM CLAVATUM SPORE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - VERATRUM ALBUM ROOT -TRP Company04149220-c7ce-4312-9630-f93d6def3aaa2025-12-15WarningsExact identifier
unii: T7J046YI2B
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: T7J046YI2B
Natural Relief Cold and Flu Plus ZincALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUMTRP Company2a352cf2-48fb-4862-e063-6294a90a2eeb2025-12-15WarningsExact identifier
unii: T7J046YI2B
unii: 1W0775VX6E
ViscumforcePASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AURUM METALLICUM, BARYTA CARBONICA, GLONOINUM, PHOSPHORUS, PLUMBUM METALLICUM, VISCUM ALBUMBioActive Nutritional, Inc.5848e409-f0b5-4323-ad00-8d058e85aaf42025-12-15WarningsExact identifier
unii: 27YLU75U4W
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab4b75-7a52-46b1-e063-6294a90a72532025-12-14WarningsExact identifier
unii: 3K9958V90M
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab2ced-cc6f-2c20-e063-6294a90a36d92025-12-14WarningsExact identifier
unii: 3K9958V90M
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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