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 129 of 244 · 4,877 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Moisturizing Hand Sanitizer, Peach ScentedALCOHOLFourstar Group USA, Inc.340879c5-4a51-44ca-9b28-9f24a1111efd2025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Strawberry Cake ScentedALCOHOLFourstar Group USA, Inc.d4db52eb-d207-410e-bcc0-08a97eb141cc2025-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care CARAMEL HONEY HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.ffd8dfae-3205-455d-8bbe-9e9f8ee859e12025-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care SWEET CITRUS HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5bcc5f69-713c-45c5-aa19-6a1086c71c352025-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care JUICY BERRY HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.8f9feca1-59e9-4be9-9b89-0a615be159ef2025-06-16WarningsExact identifier
unii: 3K9958V90M
Smart Care PISTACHIO BRULE HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.3a88b38c-f754-4756-be73-e1c03fe607302025-06-16WarningsExact identifier
unii: 3K9958V90M
Lacura Moisturizing Hand SanitizerETHYL ALCOHOL 62%Aldidafa52fe-42e6-2c21-e053-2995a90a413f2025-06-13WarningsExact identifier
unii: 3K9958V90M
RefresherALCOHOLJao Limited1debc8ca-2ea4-40c3-ad1e-8c1dc763d0f82025-06-13WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Sugar Plum ScentedALCOHOLFourstar Group USA, Inc.5a1a58d4-dddf-45f7-a327-b18a6eed44d42025-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Cucumber Melon HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.cdae74d9-48a7-47dc-b006-8e2b0c2562572025-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Sweet Citrus HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3c1581c6-c615-463e-83ad-cc84391b80e72025-06-12WarningsExact identifier
unii: 3K9958V90M
Emetrol CherryPHOSPHORATED CARBOHYDRATEWellSpring Pharmaceutical Corporationa8469128-592a-4682-82c7-4d2a6f97a9982025-06-10WarningsExact identifier
unii: 6YSS42VSEV
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.371ef8bb-9e3e-e5cc-e063-6394a90a4b6e2025-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer SpidermanALCOHOLShenzhen Lantern Scicence Co.,Ltd.371f6cbb-0164-e82d-e063-6294a90ae2df2025-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer --SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.371b5429-a392-02d0-e063-6294a90a7fe82025-06-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer TransformerALCOHOLShenzhen Lantern Scicence Co.,Ltd.371c47f6-ba88-4a7c-e063-6294a90a16972025-06-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Passion Fruit HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.0fec6b2c-21ac-44ae-8e84-5e3795fdd5d52025-06-06WarningsExact identifier
unii: 3K9958V90M
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: 27YLU75U4W
Singular WipesALCOHOLSINGULAR ENTERPRISES LLC03957345-ccd0-4def-b528-7733e6a24cbb2025-06-06WarningsExact identifier
unii: 3K9958V90M
Singular Wipes lavender fragranceALCOHOLSINGULAR ENTERPRISES LLC9499fde0-ec1c-4880-b83b-62bc78686d992025-06-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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