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 82 of 249 · 4,965 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EcoChoice Sterno Hand Sanitizer Lemon ZestALCOHOLSTERNO PRODUCTS, LLC576b7579-f44d-4315-a9c6-09d9a6d3f61d2026-01-07WarningsExact identifier
unii: 3K9958V90M
EcoChoice Sterno Hand Sanitizer Clean and FreshALCOHOLSTERNO PRODUCTS, LLC6647babe-1d1a-4a23-9042-66d950355c812026-01-07WarningsExact identifier
unii: 3K9958V90M
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD1a451616-b16e-8aa7-e063-6294a90a26a12026-01-07WarningsExact identifier
unii: 3K9958V90M
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ff95b833-3760-4e34-9636-90b423fc0d7b2026-01-07WarningsExact identifier
unii: 27YLU75U4W
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: U0NQ8555JD
unii: 1W0775VX6E
BryoniaBRYONIA ALBA ROOTBoiron8489ca49-bfdf-0df7-e053-2991aa0af54f2026-01-06Exact identifier
unii: T7J046YI2B
SPA HAND SANITIZER VANILLAETHYL ALCOHOLRejoice International Corp.47c3c187-da54-7c3b-e063-6294a90af3ce2026-01-06WarningsExact identifier
unii: 3K9958V90M
SPA HAND SANITIZER CHAMPAGNE BLASHETHYL ALCOHOLRejoice International Corp.47c5e9af-4ea8-fb39-e063-6394a90aa5ab2026-01-06WarningsExact identifier
unii: 3K9958V90M
Proctozone-GGLYCERINRising Pharma Holdings, Inc.8a5c8ad5-3619-4971-967d-165270a20bc82026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Proctozone GMaxGLYCERINRising Pharma Holdings, Inc.a13c2be6-d650-4b53-bddd-d55e92fe10c62026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Good Sense Hemorrhoidal Maximum Strength Pain ReliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUML. Perrigo Company1d6142b6-3746-46f1-99ec-4b19d26f056e2026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Dehydrated AlcoholALCOHOLBPI Labs, LLC314b1dab-8f4f-49ae-a105-f974842818b82026-01-05Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Sting Relief prep PadSTING RELIEF PREP PADSHENZHEN BENLIJU BIO-TECH CO.,LTD202c7b77-1a48-52a5-e063-6394a90a2eb22026-01-05WarningsExact identifier
unii: PDC6A3C0OX
Skin Cleaning Care WipesSKIN CLEANING CARE WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD203d7a95-65fe-ca65-e063-6294a90acc6e2026-01-05WarningsExact identifier
unii: PDC6A3C0OX
Hand Sanitizing WipesHAND SANITIZING WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD37487da6-4e0e-6625-e063-6394a90a0af12026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Vanilla HeavenALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a0781b-9b25-f04b-e063-6294a90ae7e52026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a16397-dff3-7d79-e063-6394a90a040f2026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Watermelon ScentedALCOHOLFOURSTAR GROUP USA, INC.74176b95-7899-47c7-a330-87f603aa12f52026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Cucumber Mint ScentedALCOHOLFOURSTAR GROUP USA, INC.437cb27e-4a42-4f36-ae0a-9e456055a1832026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Dragon Fruit Bloom ScentedALCOHOLFourstar Group USA, Inc.4e256c4a-6b58-4011-80f5-51d7527943de2026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Sandstone Mist ScentedALCOHOLFourstar Group USA, Inc.a9809d18-48c9-483b-bba4-5e9257533d1f2026-01-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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