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 136 of 244 · 4,877 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: XF417D3PSL
WIPESPLUS HAND SANITIZING WIPESALCOHOLCFS Brands396e1b0a-1a0e-7dd0-e063-6394a90a67b02025-04-21WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOLNINGBO TIANBO FIRST AID PRODUCT CO., LTD.88a14b15-09d6-45de-97b6-cddce7ca420b2025-04-19WarningsExact identifier
unii: 3K9958V90M
ELLEN HAND SANITIZERETHYL ALCOHOLPT. SUPER HOME PRODUCT INDONESIA33077eab-e686-249d-e063-6394a90a1b6d2025-04-18WarningsExact identifier
unii: 3K9958V90M
Smart Care HAND SANITIZER CARAMEL HONEYETHYL ALCOHOLAshtel Studios, Inc.e776362d-a05e-4e81-884c-fdf4511b4eab2025-04-18WarningsExact identifier
unii: 3K9958V90M
Smart Care HAND SANITIZER PISTACHIO BRULEEETHYL ALCOHOLAshtel Studios, Inc.79cf68b6-b3e5-416e-8020-387be82f96a22025-04-17WarningsExact identifier
unii: 3K9958V90M
Sierra Soft Alcohol Hand SanitizerETHYL ALCOHOLCWGC LA Inc.012463da-94cf-4975-9fa2-6c323855bf572025-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care HAND SANITIZER PASSION FRUITETHYL ALCOHOLAshtel Studios, Inc.a187d969-8f9e-439d-8c36-b54f86f7172a2025-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care HAND SANITIZER VANILLA SHEAETHYL ALCOHOLAshtel Studios, Inc.a3b3a610-6c8d-4145-a162-586c0e3e8d422025-04-17WarningsExact identifier
unii: 3K9958V90M
Childrens Cold CrushACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PULSATILLA, SAMBUCUS NIGRAGenexa Inc.32ece9d6-b346-6304-e063-6394a90a182d2025-04-16WarningsExact identifier
unii: 639KR60Q1Q
unii: 62I3C8233L
unii: T7J046YI2B
unii: U0NQ8555JD
Smart Care HAND SANITIZER JUICY BERRYETHYL ALCOHOLAshtel Studios, Inc.3377c631-14a7-4430-8a35-9844feb701ac2025-04-16WarningsExact identifier
unii: 3K9958V90M
Smart Care HAND SANITIZER SWEET CITRUSETHYL ALCOHOLAshtel Studios, Inc.2fbecb05-f728-4b7d-a5bf-9e62e9254b272025-04-16WarningsExact identifier
unii: 3K9958V90M
BiopureHAND SANITIZER SPRAYQuest USA Corp323c61fd-adee-393c-e063-6394a90a5eb32025-04-15WarningsExact identifier
unii: 3K9958V90M
BiopureHAND SANITIZER SPRAYQuest USA Corp324b140d-9d43-1c2f-e063-6294a90ae3032025-04-15WarningsExact identifier
unii: 3K9958V90M
COLDCALMONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoironda32d4e3-f049-e7c8-e053-2a95a90a57902025-04-15WarningsExact identifier
unii: 639KR60Q1Q
unii: 1W0775VX6E
Ligatend LiquescenceHYPERICUM PERFORATUM, RUTA GRAVEOLENS, ARNICA MONTANA, BRYONIA (ALBA), CHONDROITIN SULFATE, COLLAGEN, EUPATORIUM PERFOLIATUM, MEDULLA OSSIS SUIS, RHUS TOX, MANGANUM METALLICUM, MAGNESIUM METALLICUMNutritional Specialties, Inc.9493a7ac-7100-4c34-9233-7f62e92358522025-04-14WarningsExact identifier
unii: T7J046YI2B
unii: 1W0775VX6E
Hand Sanitizer GelHAND SANITIZER GELLS Promotions Inc.32d72358-9273-617c-e063-6294a90a68212025-04-14WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b88e9f-d3e7-c78c-e063-6294a90a67072025-04-14WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.3269a702-59a3-af3b-e063-6394a90a97d22025-04-14WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Spicy CranberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b8e946-b52b-fa2e-e063-6294a90ae1a72025-04-14WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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