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 111 of 246 · 4,918 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BCBGENERATION HAND SANITIZER COCONUT WATER SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOe96b8df6-0b8b-4b2a-806d-f65b85191fc62025-10-15WarningsExact identifier
unii: 3K9958V90M
Anti NauseaDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDCardinal Healthb2f0e93f-a2e9-4970-bfb8-de30a62478132025-10-14WarningsExact identifier
unii: 6YSS42VSEV
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
unii: PDC6A3C0OX
Smart Care Barbie SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.0d6a56a0-f678-4e23-ac66-aab35c55fbf32025-10-14WarningsExact identifier
unii: 3K9958V90M
Alcohol wipes Hand Sanitizing WipesALCOHOLDGE Essentials Incd14bf315-b0fa-4d3c-9801-e28678818af92025-10-14WarningsExact identifier
unii: 3K9958V90M
Smart Care Crayola ROYAL PURPLE SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.4246fbcf-7210-4767-b84b-b7b15ae767952025-10-13WarningsExact identifier
unii: 3K9958V90M
Smart Care Peppa Pig SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.b0e514f4-5342-4e67-9410-c3d6ce9dc9f62025-10-13WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION HAND SANITIZER PEONY BLUSH SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO3f53a401-86d9-45d6-a526-5efd00546a032025-10-13WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer SUGAR MACARON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO4d4dae53-e00b-4ce4-8e14-ba38583fdaf22025-10-13WarningsExact identifier
unii: 3K9958V90M
Smart Care MY LITTLE PONY SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.073a8f7d-a1d4-4cb3-94f8-efb449f96b472025-10-13WarningsExact identifier
unii: 3K9958V90M
Smart Care TRANSFORMER SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.6fe631ed-d76d-4076-ae29-e4b2133a4ef02025-10-13WarningsExact identifier
unii: 3K9958V90M
Be Smart Get Prepared Sting Relief WipeBENZOCAINE, ALCOHOLTotal Resources International, Inc5415073f-aa1d-4ed3-aa30-7470cd2efed12025-10-10WarningsExact identifier
unii: 3K9958V90M
Larynx LevisticumLARYNX LEVISTICUMUriel Pharmacy Inc.8db7f52e-648f-4208-8784-ef2a662fe7902025-10-10WarningsExact identifier
unii: T7J046YI2B
Lemyn Organics Medical-Grade Hand SanitizerALCOHOLLemyn LLCb106289d-346a-74df-e053-2995a90aa4262025-10-10WarningsExact identifier
unii: 3K9958V90M
Be Smart Get Prepared Sting Relief WipeALCOHOL, LIDOCAINE HYDROCHLORIDETotal Resources International, Incfff6f057-739e-40f1-8427-e1364c65af052025-10-09WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLZhejiang Hudson Import& Export Co., Ltd40b6c96c-e36f-6588-e063-6394a90adb462025-10-09WarningsExact identifier
unii: 3K9958V90M
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
unii: PDC6A3C0OX
Fibromyalgia SupportACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CONIINUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI BICHROMICUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, URICUM ACIDUMThe Magni Company36892361-994e-4a6d-972a-9ea9b72f89fe2025-10-09WarningsExact identifier
unii: 639KR60Q1Q
unii: U0NQ8555JD
HAND SANITIZER CHERRY ON TOPETHYL ALCOHOLPearl World Inc.218fc79e-5a57-4561-9986-f723dc12928d2025-10-09WarningsExact identifier
unii: 3K9958V90M
DigiSanALCOHOLEcolab Inc.aa921967-cd15-4bc2-9452-7637462747022025-10-09WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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