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 140 of 244 · 4,862 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DrainparSOLIDAGO VIRGAUREA, TRIFOLIUM PRATENSE, PROPOLIS, HEPAR SUIS, KIDNEY (SUIS), LYMPH NODE (SUIS), BERBERIS VULGARIS, BRYONIA (ALBA), CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, NUX VOMICA, SARSAPARILLA (SMILAX REGELII), TARAXACUM OFFICINALEEnergique, Inc.c7a223f3-3ae4-41b3-82cd-2082539aedde2025-03-18WarningsExact identifier
unii: T7J046YI2B
Smart Care Strawberry Hand Sanitizer strawberry 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3086faf2-e6e3-a7da-e063-6394a90ace542025-03-17WarningsExact identifier
unii: 3K9958V90M
ThroatCalmARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTEDLaboratoires Boiron94afc290-2d11-11e7-818d-424c583030312025-03-17WarningsExact identifier
unii: T7J046YI2B
Smart Care GOLDEN GROVE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.c2e2ea25-eeef-4143-9b80-aa05daf1de7d2025-03-17WarningsExact identifier
unii: 3K9958V90M
Alcare OR Foaming Antiseptic HandrubALCOHOLSC Johnson Professional USA Incb3a54ee6-fe64-4b48-8208-7bd586dfd0892025-03-14WarningsExact identifier
unii: 3K9958V90M
AEROCLEANSE Instant Hand SanitizerINSTANT HAND SANITIZERAero Healthcare45aad3a4-dc7e-4b51-e054-00144ff88e882025-03-12WarningsExact identifier
unii: 3K9958V90M
Lymphastat VECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, SAMBUCUS NIGRA, ACONITUM NAPELLUS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, RHUS TOX, PYROGENIUM, INFLUENZINUM (2023-2024)Energique, Inc.c0ef1647-22f9-4cfa-a7e6-90c47c93dbde2025-03-11WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: U0NQ8555JD
unii: CT03BSA18U
unii: 1W0775VX6E
Signature Care Instant Hand Sanitizizer WipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.0f6a30de-4100-4673-ab9e-256bb137919b2025-03-11WarningsExact identifier
unii: 3K9958V90M
Lymphastat VECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, SAMBUCUS NIGRA, ACONITUM NAPELLUS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, INFLUENZINUM (2021-2022), LACHESIS MUTUS, RHUS TOX, PYROGENIUMEnergique, Inc.9ec6f663-5f15-4daf-a36b-49fbe1c53a6c2025-03-11WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: U0NQ8555JD
unii: CT03BSA18U
unii: 1W0775VX6E
Terramed Just Think Comfort leg crampACONITUM NAPELLUS,ARNICA MONTANA,MAGNESIUM PHOSPHORICA,RHUS TOXICODENDRON,VISCUM ALBUMRida LLC741d5ade-cd99-44fa-99fe-02b61655ca632025-03-10WarningsExact identifier
unii: U0NQ8555JD
SleepCalmMATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUMBoironde0b458d-5f0a-78f4-e053-2995a90afe4b2025-03-07Exact identifier
unii: 639KR60Q1Q
Smart Care Assorted Hand Sanitizer Sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2fa8bf7a-8efc-923d-e063-6394a90a6bbb2025-03-06WarningsExact identifier
unii: 3K9958V90M
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
unii: PDC6A3C0OX
BART PLUSACONITUM NAPELLUS, APIS MELLIFICA, ARBUTUS ANDRACHNE, ARNICA MONTANA, ARSENICUM ALBUM, COCCULUS INDICUS, ECHINACEA (ANGUSTIFOLIA), GLYCYRRHIZA GLABRA, GUNPOWDER, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALMIA LATIFOLIA, LAC CANINUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, STRAMONIUM, TELLURIUM METALLICUM, THYROIDINUM (SUIS), VERATRUM ALBUMDeseret Biologicals, Inc.4de3d6d4-108c-41b9-8aa7-4225ce494d782025-03-04WarningsExact identifier
unii: U0NQ8555JD
Smart Care Assorted Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f800ea4-b8bb-0cb4-e063-6294a90a7e232025-03-04WarningsExact identifier
unii: 3K9958V90M
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
unii: PDC6A3C0OX
Sambucus Cold Flu Relief Hot Drink Lemon FlavoredPELARGONIUM SIDOIDES, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, SEMPERVIRENS, PHOSPHORUSUniversal Synergetics, Inc2ca2064a-2011-48fb-a47a-837ea3fc9bf62025-03-04WarningsExact identifier
unii: 27YLU75U4W
unii: 639KR60Q1Q
unii: 62I3C8233L
unii: T7J046YI2B
unii: U0NQ8555JD
unii: CT03BSA18U
unii: 1W0775VX6E
unii: S546YLW6E6
Clorox Hand SanitizerALCOHOLBrand Buzz LLCbdd47d2f-5332-1430-e053-2a95a90a1c332025-03-03WarningsExact identifier
unii: 3K9958V90M
T/T WAG Hand Sanitizer Mist Watermelon 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f7c4066-3baa-25f2-e063-6394a90a00eb2025-03-03WarningsExact identifier
unii: 3K9958V90M
Moxie Hand Sanitizing GelALCOHOLSkaffles Groupfbb5cd9c-c9dc-42ed-9035-f57455ce092a2025-03-02WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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