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 98 of 246 · 4,918 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMORA Spray. Hand Sanitizer CherryALCOHOLLongway Technology(Guangzhou) Co., Ltd.44e04959-a21e-ba62-e063-6394a90a71922025-12-01WarningsExact identifier
unii: 3K9958V90M
Walgreen Anti Nausea Cherry FlavorPHOSPHORATED CARBOHYDRATEWALGREENS CO.69e72d30-feca-454d-addc-8ed7325568d32025-12-01WarningsExact identifier
unii: 6YSS42VSEV
Digestive CareBISMUTHUM METALLICUM, ANTIMON.CRUD., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CHAMOMILLA, CINCHONA, IRIS VERSICOLOR, KALI BIC., LACHESIS, LYCOPODIUM, MAG. CARB., NUX VOM., PHOSPHORUS, PODOPH. PELT., PULSATILLA, RAPHANUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM, ZINGIBER, ECHINACEA, JUGLANS REGIA.Newton Laboratories, Inc.44e7e28b-88e5-784b-e063-6294a90a60022025-12-01WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
Hand Sanitizing WipeALCOHOLNeatGoods LLCb700ff10-2836-7893-e053-2995a90a43222025-12-01WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLNeatGoods LLCf7584f1a-e459-98f9-e053-6394a90a87922025-12-01WarningsExact identifier
unii: 3K9958V90M
CareALL Hand SanitizerALCOHOLNew World Imports, Inc.025a42bb-37e0-4d74-8f94-8a9ef2296f4c2025-12-01WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.263457cc-35ff-62fb-e063-6394a90a94da2025-12-01WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.2507df2c-9069-01c1-e063-6394a90a85962025-12-01WarningsExact identifier
unii: 3K9958V90M
HeadacheELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.44ffafd7-8b43-5a24-e063-6294a90a80a32025-12-01WarningsExact identifier
unii: 27YLU75U4W
unii: 639KR60Q1Q
unii: T7J046YI2B
SOUR LEMON Hand Sanitizer SOUFFLE VANILLA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO8436deda-2a91-446a-9633-53965cf33beb2025-12-01WarningsExact identifier
unii: 3K9958V90M
BUDDATE INONOTUS OBLIQUUS WATER BRILLIANCE MASKBUTYLENE GLYCOL, GLYCERIN, INONOTUS OBLIQUUS (MUSHROOM) EXTRACTBUDDATE Co Ltd464988ad-557e-13f5-e054-00144ff8d46c2025-11-30WarningsExact identifier
unii: PDC6A3C0OX
BUDDATE LOTUS MOISTURE ESSENCEGLYCERIN, NIACINAMIDE, NELUMBO NUCIFERA FLOWER EXTRACT, PORTULACA OLERACEA EXTRACTBUDDATE Co Ltd46499995-8b13-3e5c-e054-00144ff88e882025-11-30WarningsExact identifier
unii: PDC6A3C0OX
BCBGENERATION HAND SANITIZER HIBISCUS SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO36d72b23-a4ab-4196-b773-5bf5ddafa5262025-11-29WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer CUCUMBER MELON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2a6d6230-e9df-4af1-96ed-36efe1df8f292025-11-28WarningsExact identifier
unii: 3K9958V90M
EO Hand Sanitizer Wipes LavenderALCOHOLEO Products, LLCb66895a9-17eb-4493-aa9d-7ef4b2b0194a2025-11-27WarningsExact identifier
unii: 3K9958V90M
Alcohol WipesALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD448e7c82-f952-4993-e063-6394a90a942c2025-11-27WarningsExact identifier
unii: 3K9958V90M
FF SILICONE SPRY SANI PPKFF SILICONE SPRY SANI PPKZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD4493c534-187e-f680-e063-6294a90aacdb2025-11-27WarningsExact identifier
unii: 3K9958V90M
everyone Hand Sanitizer Coconut LemonALCOHOLEO Products, LLC16528009-90cf-46b8-9719-bdc6f435a1912025-11-27WarningsExact identifier
unii: 3K9958V90M
Everyone Hand Sanitizer ruby grapefruitALCOHOLEO Products, LLC045151b3-f08c-4e02-be33-00271e15b7f02025-11-27WarningsExact identifier
unii: 3K9958V90M
Cartilago BetulaCARTILAGO BETULAUriel Pharmacy Inc.e7d65386-3248-4b21-8aa6-c1a5dbeb8cca2025-11-26WarningsExact identifier
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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