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 44 of 249 · 4,965 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Advanced Hand Sanitizer with AloeETHYL ALCOHOL 70%Veridian Healthcare4e55e971-775a-0d69-e063-6394a90a79562026-03-31WarningsExact identifier
unii: 3K9958V90M
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.ad6a08ec-5eba-405b-8a07-79ac86ab3e7a2026-03-31WarningsExact identifier
unii: U0NQ8555JD
CirculatoneFAGOPYRUM ESCULENTUM, MAGNESIA MURIATICA, CITRUS BIOFLAVONOIDS, HEART (SUIS), THYROIDINUM (SUIS), ARSENICUM IODATUM, AURUM MURIATICUM, BARYTA MURIATICA, CALCAREA IODATA, CHOLESTERINUM, CONIUM MACULATUM, KALI IODATUM, PLUMBUM METALLICUM, ARNICA MONTANA, PHOSPHORUSBioActive Nutritional, Inc.465fb3c6-88e6-4099-a26a-33991ec5a1062026-03-31WarningsExact identifier
unii: 27YLU75U4W
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX
FIGS - evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLWE EVOLVETOGETHER INC.4e432300-7d2f-ed59-e063-6394a90a22b82026-03-30WarningsExact identifier
unii: 3K9958V90M
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
unii: PDC6A3C0OX
ANX HPARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUMBioActive Nutritional, Inc.96035891-aea3-4138-bb26-801ad819f6392026-03-30WarningsExact identifier
unii: 27YLU75U4W
IsagelALCOHOLColoplast Corpeba7e574-25c2-445a-98f6-2d10454554662026-03-27WarningsExact identifier
unii: 3K9958V90M
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
unii: PDC6A3C0OX
Giant EagleALCOHOLApollo Health and Beauty Care419846a1-8d22-16f0-e063-6394a90a6bdd2026-03-27WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Fragrance FreeALCOHOLGOJO Industries, Inc.4e06bb4a-e1a5-8c79-e063-6294a90a293c2026-03-27WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer be BlissfulALCOHOLGOJO Industries, Inc.cebd0adb-dc26-407f-a290-418e0e206aea2026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Fig ScentedALCOHOLFourstar Group USA, Inc.b66cd8a7-98ea-43b0-a92b-7d1da15f50142026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Cherry ScentedALCOHOLFourstar Group USA, Inc.290674c5-1622-451e-abd6-b586117827c32026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Vanilla Honey ScentedALCOHOLFourstar Group USA, Inc.f2eb0f80-083e-478a-a8df-0d2bb85901ad2026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Peachy Cherry Bliss ScentedALCOHOLFourstar Group USA, Inc.835a6a4c-1582-46fd-b5c3-4b79dbe11d502026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand SanitizerSugared Strawberry ScentedALCOHOLFourstar Group USA, Inc.15e732fe-5c4b-4f3a-9dd5-a4f7015f75422026-03-27WarningsExact identifier
unii: 3K9958V90M
Lymph Tonic IECHINACEA (ANGUSTIFOLIA), KALI IODATUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, HYPOPHYSIS SUIS, APIS MELLIFICA, ARANEA DIADEMA, BELLADONNA, CALCAREA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, GALIUM APARINE, GRAPHITES, LACHESIS MUTUS, MERCURIUS PRAECIPITATUS RUBER, MYRISTICA SEBIFERA, PHOSPHORUS, RHUS TOX, SCROPHULARIA NODOSA, SULPHUR, THYROIDINUM (SUIS), VESPA CRABROBioActive Nutritional, Inc.9b9a639c-0a91-48b5-b1ff-6b82c6a568ef2026-03-27WarningsExact identifier
unii: 27YLU75U4W
IsagelALCOHOLColoplast Corp5be93a24-c644-4e6b-a600-87f0a5a09e5c2026-03-27WarningsExact identifier
unii: 3K9958V90M
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.077a9171-283d-47b6-bddc-34c739f6d69d2026-03-27WarningsExact identifier
unii: 27YLU75U4W

Reported adverse events (FAERS/openFDA)#

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