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 141 of 244 · 4,862 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Procure Products Hand Sanitizing WipesALCOHOL 70% ANTIBACTERIAL WIPESTWIN MED LLC1f378bee-88f7-14cf-e063-6394a90a48882025-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerINSTANT HAND SANITIZERRaining Rose, Inc2f37a2a1-5250-4052-e063-6294a90aef7f2025-02-28WarningsExact identifier
unii: 3K9958V90M
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.a20c821a-80d9-499c-aecd-3cf4d8e025902025-02-27WarningsExact identifier
unii: 3K9958V90M
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.d5d0badb-5e1b-4ea8-bea2-0e8cf714b69e2025-02-27WarningsExact identifier
unii: 3K9958V90M
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.f2309f34-a1ee-44c7-b818-7384de64d27b2025-02-27WarningsExact identifier
unii: 3K9958V90M
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.dcfc08a0-ecd6-42d3-9ff2-e68d5317152f2025-02-27WarningsExact identifier
unii: 3K9958V90M
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: 3K9958V90M
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
COCONUT SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.fe347d07-496a-468a-bc38-d47b0f22c4332025-02-25WarningsExact identifier
unii: 3K9958V90M
CITRUS SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.64b2fef3-8d06-471d-b950-d4c355119dfa2025-02-25WarningsExact identifier
unii: 3K9958V90M
LAVENDER SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.0e5e21c3-9ee5-44be-988a-f82ac95230592025-02-25WarningsExact identifier
unii: 3K9958V90M
ALOE SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.aacde143-ecf1-47ce-ada3-8e74551d06592025-02-25WarningsExact identifier
unii: 3K9958V90M
EUCALYPTUS SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.068ed8c0-1fff-42dd-a217-684201c160232025-02-25WarningsExact identifier
unii: 3K9958V90M
SHEA BUTTER SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.669451fa-7557-4ef5-a668-fe4fea1f0c9b2025-02-25WarningsExact identifier
unii: 3K9958V90M
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
unii: PDC6A3C0OX
Smart Care Crayola HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.def18e33-0a6b-40f8-a771-fcae1e6a1c822025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care SPIDER-MAN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.db147cc8-6323-428b-b506-8ab7211cb3e62025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Hot Wheels HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.046d534c-1bde-439c-9a90-8713aaada1a12025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Barbie HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e9acb658-946d-405c-ad41-8b52542998bd2025-02-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLUniversal Synergetics, Inc0dd6884c-935f-4523-b19a-201b7a8666fc2025-02-24WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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