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 95 of 246 · 4,918 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FCS HPEPINEPHRINE,GLUTAMICACID,MUCUNAPRURIENSSEED,NIACINAMIDE,SEROTONIN,UBIDECARENONE,CORTICOTROPIN,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATECRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inc.ba8fed68-f27f-4651-adec-0994a53758872025-12-10WarningsExact identifier
unii: XF417D3PSL
DIARRHEA CPAETHUSA CYNAPIUM, ARSENIC TRIOXIDE, OYSTER SHELL CALICUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, IRON, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLOBILIS, PHOSPHORUS, PODOPHYLLUM, ANEMONE PULSATILLA, DELPHINIUM STRAPHISAGRIA SEED, SULFURNatural Creations, Inc.06f51c41-1e76-4201-937a-cbaaf6a477af2025-12-10WarningsExact identifier
unii: 27YLU75U4W
DigestionGENTIANA LUT, SAMBUCUS NIG, ARSENICUM ALB, BISMUTH SUB, CARBO VEG, KALI BIC, LYCOPODIUM, NUX VOM, PHOSPHORUS, PULSATILLANatural Creations, Inceabd9ea9-e61d-4c18-b95f-60c9ab1b3dd82025-12-10WarningsExact identifier
unii: 27YLU75U4W
unii: CT03BSA18U
FCS CPCORTICOTROPIN,GLUTAMICACID,MUCUNAPURIENSSEED,SEROTONIN,EPINEPHRINE,NIACINAMIDE,UBIDECARENONE,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,UNSPECIFIED,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATE,CRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inccb69e9d6-62a6-4af0-8d2d-1e68b0830a202025-12-10WarningsExact identifier
unii: XF417D3PSL
Advanced Gel Hand SanitizerALCOHOLEcolab Inc.c69b563d-ea9d-4ebc-b9ca-b84bd4e0de852025-12-10WarningsExact identifier
unii: 3K9958V90M
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
EO Hand Sanitizer Wipes LavenderALCOHOLEO Products, LLC1a8cb031-5608-400f-b924-feb6bbd17fa12025-12-09WarningsExact identifier
unii: 3K9958V90M
DANDI HPMILK THISTLE, DYSPHANIA AMBROSIOIDES, BOS TAURUS BILE, GOLDEN SEAL, POTASSIUM TARTRATE HEMIHYDRATE, TARAXACUM OFFICINALE, IODINE, ARSENIC TRIOXIDE, OSTER SHELL CALCIUM CARBONATE, CRUDE, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM CHLORIDE, MERCURIUS SOLUBILIS, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUSNatural Creations, Inc.44c7d388-6c40-47e2-9760-4e5075fc0e7b2025-12-08WarningsExact identifier
unii: 27YLU75U4W
Cartilago BetulaCARTILAGO BETULAUriel Pharmacy Inc.99037dd6-b2c8-45d0-bb5f-670aed53ee462025-12-08WarningsExact identifier
unii: U0NQ8555JD
Cough and BronchialACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America791a8da1-0de3-4798-bbc9-b3538ea28dd72025-12-08WarningsExact identifier
unii: T7J046YI2B
unii: U0NQ8555JD
Cough and Bronchial Daytime SyrupACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe Mexico, S.A. de C.V.e8949f67-1b05-40a2-96a5-d4d1124915ff2025-12-08WarningsExact identifier
unii: T7J046YI2B
unii: U0NQ8555JD
Sambucus Flu ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOPSchwabe North America, Inc.ca7d57b0-ffae-415f-a959-b0c88ae7dd402025-12-08WarningsExact identifier
ndc (package): 53499-0803-5
ndc (product): 53499-0803
ndc11 (package): 53499080305
spl id: e952da08-d4e8-46a8-8330-99accec78283
spl set id: ca7d57b0-ffae-415f-a959-b0c88ae7dd40
unii: 27YLU75U4W
unii: 639KR60Q1Q
unii: 62I3C8233L
unii: T7J046YI2B
unii: U0NQ8555JD
unii: CT03BSA18U
unii: 1W0775VX6E
unii: S546YLW6E6
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.bf399508-bd29-0d90-e053-2995a90a067f2025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb351a-06fb-8222-e053-2a95a90aadbf2025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcead234-bb98-1ee8-e053-2a95a90a31862025-12-06WarningsExact identifier
unii: 3K9958V90M
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.acfdfa78-69e7-27dc-e053-2a95a90a85482025-12-06WarningsExact identifier
unii: 3K9958V90M
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.ad0cdcf1-7d8b-dcc9-e053-2995a90a4b4b2025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb9358-663c-3c70-e053-2995a90a35242025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced08e7-a0bc-1328-e053-2995a90afb262025-12-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcec13da-586c-6e7e-e053-2a95a90a6cd12025-12-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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