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 66 of 76 · 1,511 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SCIATICAIDEARSENIC TRIOXIDE, CHAMOMILE, CITRULLUS COLOCYNTHIS FRUIT PULP, SULFURSchwabe Mexico S.A. de C.V.e2c234a3-bbaf-4d84-b3ef-ad9c4f7c473f2022-07-26WarningsExact identifier
unii: 70FD1KFU70
Gelsemium SempervirensGELSEMIUM SEMPERVIRENSHahnemann Laboratories, INC.e3dc20b9-1e38-47df-e053-2995a90abc042022-07-15Exact identifier
unii: 639KR60Q1Q
Stress EZARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, LOMATIUM DISSECTUM, COBALTUM METALLICUM, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, IODIUM, VANADIUM METALLICUM, CLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PRUNUS CERASIFERA, FLOSDeseret Biologicals, Inc.9c3678c9-66c2-4f5e-8453-34a75ebb25ed2022-07-14WarningsExact identifier
unii: 639KR60Q1Q
BHI SkinBERBERIS VULGARIS ROOT BARK, GRAPHITE, HYDROFLUORIC ACID, LYCOPODIUM CLAVATUM SPORE, PETROLATUM, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, AND SULFURMediNatura Inc70ab2931-bd2d-43de-bb36-d019f78e3d732022-07-07WarningsExact identifier
unii: 70FD1KFU70
BryoniaBRYONIANewton Laboratories, Inc.e20b392e-37de-1c83-e053-2995a90a760b2022-06-22WarningsExact identifier
unii: T7J046YI2B
Bryonia AlbaBRYONIA ALBAHahnemann Laboratories, INC.de47da97-3d02-afad-e053-2995a90aaaa32022-05-05Exact identifier
unii: T7J046YI2B
Alpha CFACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS,Schwabe North America, Inc.ea0e6d54-1a25-4300-8cea-0f7c56afded12022-05-03WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
ALPHA CFACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUSSchwabe Mexico, S.A. de C.V.26afa426-eaae-437f-85a7-3bf0ad3d361b2022-05-03WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURKMM Pharmaceuticals, LLCdb841a96-42cb-6ff6-e053-2995a90a7cca2022-03-31Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9.8% and Sulfur 4.8% CleanserSULFACETAMIDE SODIUM, SULFURKMM Pharmaceuticals, LLCdb857027-0175-e452-e053-2995a90a4df52022-03-31Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
PlexionSULFACETAMIDE SODIUM, SULFUREckson Labs LLCdb71ee55-bbdd-0996-e053-2a95a90a56872022-03-30Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
PlexionSULFACETAMIDE SODIUM, SULFUREckson Labs LLCdb747368-d45d-64e3-e053-2995a90a1fb82022-03-30Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da807eb3-34a3-61b9-e053-2995a90a0e212022-03-18WarningsExact identifier
unii: T7J046YI2B
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da80a5ea-f603-719e-e053-2995a90a97102022-03-18WarningsExact identifier
unii: T7J046YI2B
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da81b21a-090a-dabf-e053-2995a90aa05e2022-03-18WarningsExact identifier
unii: T7J046YI2B
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da821d05-b2f0-3582-e053-2a95a90afe592022-03-18WarningsExact identifier
unii: T7J046YI2B
Cough - AirwayINFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPANewton Laboratories, Inc.92ae84ae-559c-79b8-e053-2a95a90aa79f2022-03-17WarningsExact identifier
unii: T7J046YI2B
unii: CT03BSA18U
Cough - AirwayINFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPANewton Laboratories, Inc.92aeb17c-8d05-a3b2-e053-2995a90a86262022-03-17WarningsExact identifier
unii: T7J046YI2B
unii: CT03BSA18U
Cold - SinusINFLUENZA A VIRUS, INFLUENZA B VIRUS, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEANewton Laboratories, Inc.7a433e80-087e-289c-e053-2a91aa0a94472022-03-17WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Cold - CoughINFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPANewton Laboratories, Inc.98e7a385-aa56-f5fe-e053-2995a90a84d32022-03-17WarningsExact identifier
unii: T7J046YI2B
unii: CT03BSA18U

Reported adverse events (FAERS/openFDA)#

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