FDA.reportPublic FDA data

NDC 52053-0004-01 - Sambucol Cold and 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
52053-0004
Requested NDC
52053-0004-01
Package NDCs from labels
52053-0004-2, 52053-0004-1, 52053-0004-01
Manufacturer
PharmaCare US, Inc. | Apotheca Company
Effective date
2024-05-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sambucol Cold and Flu Relief - PharmaCare US, Inc. | Apotheca CompanyPharmaCare US, Inc. | Apotheca Company2024-05-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52053-0004-1Sambucol Cold and Flu Relief4 in 1 CARTONTABLET43
52053-0004-2Sambucol Cold and Flu Relief4500 mg in 1 BLISTER PACKTABLET45003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52053-0004SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET [PHARMACARE US, INC.]3Current NDC, Legacy NDC, 2 package rows20240526_7dace656-ee97-4931-869f-8c8022757abb.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 41 of 76 · 1,511 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiarrheaAESCULUS HIPPOCASTANUM, JUGLANS REGIA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, ELATERIUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, RHEUM, SULPHUR, TABACUM, VACCINIUM MYRTILLUSNewton Laboratories, Inc.9d7322da-c2fb-0fc3-e053-2a95a90ac70b2025-01-27WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: 70FD1KFU70
SnifflesECHINACEA, ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, ARSENICUM ALBUM, BRYONIA, EUPHRASIA OFFICINALIS, GAULTHERIA PROCUMBENS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALVIA OFFICINALIS, STICTA PULMONARIA, THUJA OCCIDENTALIS, VERBASCUM THAPSUS, SINUSITISINUM, INFLUENZINUMNewton Laboratories, Inc.9db1327c-6746-76cb-e053-2995a90a6e272025-01-27WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.5a94659f-b62a-41d8-81c0-87a68c02606d2025-01-27WarningsExact identifier
unii: 70FD1KFU70
Jointstat BBCHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ARSENICUM ALBUM, BRYONIA (ALBA), COLCHICUM AUTUMNALE, KALMIA LATIFOLIA, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, PHOSPHORUS, RHUS TOXEnergique, Inc.97f4c278-e0fb-45f4-bc5d-1d368978dd662025-01-27WarningsExact identifier
unii: T7J046YI2B
Endopan HPACETICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, BRYONIA (ALBA), CHROMIUM, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, SYZYGIUM JAMBOLANUM, THUJA OCCIDENTALIS, URANIUM NITRICUMEnergique, Inc.2bc69a24-c24c-4d12-92bb-7c073edf90dc2025-01-24WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
Bestmade Natural Products BM59CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBestmade Natural Products2c763956-a1de-c8df-e063-6294a90a5c812025-01-24WarningsExact identifier
unii: 70FD1KFU70
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: T7J046YI2B
SODIUM SULFACETAMIDE AND SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.2c631307-b8a3-2978-e063-6394a90a79c32025-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Anti Acne Natural Volcanic SulfurSULFURPT. GALENIUM PHARMASIA LABORATORIESa19ac01b-950a-4ddb-9711-17f15bdb40132025-01-23WarningsExact identifier
unii: 70FD1KFU70
Anti Acne Natural Volcanic SulfurSULFURPT. GALENIUM PHARMASIA LABORATORIES4f230abd-5c07-4121-81da-a9fa2d20a2ca2025-01-23WarningsExact identifier
unii: 70FD1KFU70
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554
MetoxALLIUM SATIVUM, ARSENICUM ALBUM, ASCORBICUM ACIDUM, BERBERIS VULGARIS, BORON, CARBOLICUM ACIDUM, CYSTEINUM, FORMALINUM, GLYCYRRHIZA GLABRA, LANTHANUM METALLICUM, LAPPA MAJOR, L-METHIONINE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NIOBIUM METALLICUM, NUX VOMICA, PHYTOLACCA DECANDRA, PLUMBUM METALLICUM, STILLINGIA SYLVATICA, TANTALUM METALLICUM, THYROIDINUM (SUIS), TRIFOLIUM PRATENSE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,Deseret Biologicals, Inc.deeae030-c266-44ab-8bc7-32c3292c72472025-01-17WarningsExact identifier
unii: 70FD1KFU70
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUMDeseret Biologicals, Inc.1a3edb9d-e571-4275-b56e-d2489da11e762025-01-14WarningsExact identifier
unii: T7J046YI2B
SLMD Silver Sulfur Acne CreamSULFUROwen Biosciences Inc.4735a6d6-bf87-404d-a46d-7f29fcff94092025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-6ACONITUM NAPELLUS, BRYONIA ALBA WHOLE, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, CAUSTICUM, CAMPHOR (NATURAL), EUCALYPTUS GLOBULUS LEAF, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, AND SCHOENOCAULON OFFICINALE SEEDDNA Labs, Inc.27f58993-c611-4dc7-ac8e-0132f0a4fcef2025-01-13WarningsExact identifier
unii: 639KR60Q1Q
D-24BRYONIA ALBA ROOT, RANUNCULUS BULBOSUS, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, SODIUM SULFATE ANHYDROUS, AND POTASSIUM CARBONATEDNA Labs, Inc.4247e932-d5e6-4465-ae82-763dbf43d7eb2025-01-13WarningsExact identifier
unii: T7J046YI2B
D-13HORSE CHESTNUT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PAEONIA OFFICINALIS ROOT, STRYCHNOS NUX-VOMICA SEED, GRAPHITE, SULFUR, COLLINSONIA CANADENSIS ROOT, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, AND NITRIC ACIDDNA Labs, Inc.047a2c0e-9b59-45c3-85df-0a26cdc397192025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-16BLACK COHOSH, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT, GELSEMIUM SEMPERVIRENS ROOT, AND SPIGELIA ANTHELMIADNA Labs, Inc.4784ddc2-c308-4092-a01f-ea2b2954a8882025-01-13WarningsExact identifier
unii: 639KR60Q1Q
D-32NITRIC ACID, ATROPA BELLADONNA, PILOCARPUS JABORANDII WHOLE, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SAMBUCUS NIGRA FLOWERING TOP, SEPIA OFFICINALIS JUICE, SANGUINARIA CANADENSIS ROOT, VERATRUM ALBUM ROOT, AND SAGEDNA Labs, Inc81bb16d9-9c93-48d3-85ca-81c118a1c4a02025-01-13WarningsExact identifier
unii: CT03BSA18U
D-43ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.937e2b7e-4001-402f-bd12-dcff4627e9282025-01-13WarningsExact identifier
unii: T7J046YI2B

Reported adverse events (FAERS/openFDA)#

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