FDA.reportPublic FDA data

NDC 52053-0004-2 - 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
52053-0004-2
Package NDCs from labels
52053-0004-2, 52053-0004-1
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 12 of 77 · 1,540 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Sulfacetamide 9% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticalsd770b9e2-dbbe-c246-e053-2995a90a398d2026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9% and Sulfur 4.5% CleanserSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticalsd770860b-ecbd-ba22-e053-2a95a90af6912026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 8% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticalsd8dcbf63-58f0-0a25-e053-2a95a90a76332026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10% and Sulfur 2% CleanserSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticalsd736fbd6-4cff-bc33-e053-2a95a90a26fd2026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient CreamSODIUM SULFACETAMIDE 10% AND SULFUR 5% EMOLLIENT CREAMMethod Pharmaceuticals, LLCdfc5bab2-2170-606e-e053-2a95a90a39612026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
sulfacetamide sodium and sulfur Sodium Sulfacetamide - SulfurSULFACETAMIDE SODIUM AND SULFURAllegis Pharmaceuticals, LLC1aa1025f-c568-34d3-e063-6394a90a37b82026-02-11Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
dermveda NAIL FUNGUS SERUMOLIVE EXTRACT, SULFURCelcius Corp.6d999dac-7b84-4f19-957e-5c787a4e96c42026-02-09WarningsExact identifier
unii: 70FD1KFU70
Dermveda JOCK ITCHSULPHUR, CURCUMA LONGACelcius Corp.bb9c3941-a778-49ba-b58c-75ab5b93b3d02026-02-09WarningsExact identifier
unii: 70FD1KFU70
dermveda PSORIASIS AND SEBORRHEIC DERMATITISSULFUR, CURCUMA LONGACelcius Corp.a05c1e45-ca2f-49a1-a3f9-32dc51278fb62026-02-09WarningsExact identifier
unii: 70FD1KFU70
dermveda SCABIES ITCH RELIEF SERUMOLIVE EXTRACT, SULFURCelcius Corp.86a8bffd-81a8-4f22-89b6-e51158f336db2026-02-09WarningsExact identifier
unii: 70FD1KFU70
dermveda JOCK ITCHOLIVE EXTRACT, SULFURCelcius Corp.252ed439-0e4c-419f-8b34-d1b52da8464f2026-02-06WarningsExact identifier
unii: 70FD1KFU70
Cough and Mucus NightANTIMONIUM TARTARICUM, AVENA SATIVA, BRYONIA (ALBA), CHAMOMILLA, DROSERA (ROTUNDIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), SAMBUCUS NIGRA, STANNUM METALLICUM, SULPHURNaturalCaref27e3a7f-78a3-4003-95fc-0b32671df4432026-02-02WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
unii: CT03BSA18U
Candida Yeast CareBAPTISIA TINCTORIA, BRYONIA (ALBA), CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, HELONIAS DIOICA, KREOSOTUM, THUJA OCCIDENTALIS, VISCUM ALBUMNaturalCare1a36086e-b34c-4937-a095-c9e101b59e662026-01-30WarningsExact identifier
unii: T7J046YI2B
Varicose VeinsELAPS CORALLINUS, CROTALUS HORRIDUS, BRYONIA, CALC. FLUOR., CARDUUS MAR., CHOLESTERINUM, CINCHONA, DIGITALIS, HAMAMELIS, HYDROFLUORICUM ACIDUM, LACHESIS, LYCOPODIUM, NAJA, PULSATILLA, VIPERA BERUS, ZINC. MET., AESCULUS HIPP., ECHINACEANewton Laboratories, Inc.91e8e37c-c654-6df9-e053-2995a90aafe12026-01-29WarningsExact identifier
unii: T7J046YI2B
OHM-DAMAGNUS CASTUS, AVENA SATIVA, DAMIANA, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, LYCOPODIUM CLAVATUM, ORCHITINUM, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SELENIUM METALLICUM, TRIBULUS TERRESTRIS, YOHIMBINUMOHM PHARMA INC.e43b1786-86dd-4716-b066-e5fda25996302026-01-28WarningsExact identifier
unii: 639KR60Q1Q
OHM-RESBACONITUM, ARANEA, BRYONIA, EQUISETUM, EUPATORIUM PERF, HYDRASTIS, JUGLANS REG, KALI BIC, PHOSPHORUS, SARSAPARRILLA, SULPHUROHM PHARMA INC.49e4b472-9ac3-465e-acfa-8879939ce7b42026-01-28WarningsExact identifier
unii: T7J046YI2B
NeoRelief for Menstrual Pain and CrampsHOMEOPATHIC PAIN RELIEF GELBioLyte Laboratories, LLC71c2a2f7-4823-51cb-e053-2995a90a5fb82026-01-27WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
NEORELIEF FOR PAINTOPICAL GEL FOR PAINBioLyte Laboratories, LLC46df076d-4e3a-6faa-e054-00144ff8d46c2026-01-27WarningsExact identifier
unii: T7J046YI2B
Pollen DistressALLIUM CEPA, APIS MELLIFICA, ARALIA RACEMOSA, ARUNDO MAURITANICA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SABADILLA, SANGUINARIA CANADENSIS, URTICA URENSLiddell Laboratories, Inc.034fcd90-81f7-4597-b58b-e2ed7047f6bd2026-01-26WarningsExact identifier
unii: 639KR60Q1Q
DHC Acne Spot TherapySULFURDHC USA Incorporated84d49048-95cf-4f14-9698-c746237fec9d2026-01-24WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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