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 123 of 244 · 4,877 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
unii: PDC6A3C0OX
365 Whole Foods Market Refreshing Hand Sanitizer Bergamot RainETHYL ALCOHOLWhole Foods Market, Inc.3c6b1a51-4097-1aad-e063-6294a90aef6f2025-08-15WarningsExact identifier
unii: 3K9958V90M
Natures Way Cold Flu Relief Fastactives Berry FlavoredPELARGONIUM SIDOIDES WHOLE, ACONITUM NAPELLUS WHOLE, EUCALYPTUS GLOBULUS LEAF, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM TOP, SEMPERVIRENS ROOT, PHOSPHORUS, IPECACUniversal Synergetics, Inc444081b1-c78f-4474-a084-e7bd2cc2eb3f2025-08-14WarningsExact identifier
unii: 27YLU75U4W
unii: 639KR60Q1Q
unii: 62I3C8233L
unii: T7J046YI2B
unii: U0NQ8555JD
unii: 1W0775VX6E
unii: S546YLW6E6
Smart Care Luxury Hand Sanitizer Midnight MuskALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c5f46b4-f202-2a44-e063-6294a90ac1062025-08-14WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer Meadow MirageALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c5f8420-9673-6f77-e063-6294a90a81e42025-08-14WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Coconut BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3af609-d342-449a-e063-6294a90a0a192025-08-13WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Fresh RainALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3bd802-56de-ebcd-e063-6294a90aca152025-08-13WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Wild RoseALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3c78f6-e6cb-e456-e063-6394a90ac5b82025-08-13WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c4bceac-21bc-486e-e063-6394a90a0f372025-08-13WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c25e093-0335-fa1d-e063-6394a90ae6842025-08-12WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c266de8-0551-374c-e063-6394a90ab9f42025-08-12WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c236c0b-fccd-6992-e063-6294a90a37ce2025-08-11WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c2322e0-90d5-6ce6-e063-6394a90ac8bb2025-08-11WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c23d45e-9050-5b9e-e063-6294a90abd4a2025-08-11WarningsExact identifier
unii: 3K9958V90M
Smart Care CHAMPAGNE TOAST HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.76190577-c74e-4671-8abe-3f158ce662f02025-08-11WarningsExact identifier
unii: 3K9958V90M
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
unii: PDC6A3C0OX
Aruba Aloe Hand SanitizerALCOHOLAruba Aloe Balm NV3bc6d696-43d2-9516-e063-6294a90ae82b2025-08-07WarningsExact identifier
unii: 3K9958V90M
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
365 Whole Foods Market Refreshing Hand Sanitizer Citrus SunshineETHYL ALCOHOLWhole Foods Market, Inc.3bcf1071-2308-b989-e063-6294a90a68232025-08-07WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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