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 13 of 77 · 1,540 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE 9.8% SULFUR 4.8%Aspen Medical LLC4915e4eb-5307-d2db-e063-6394a90a67b32026-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Joint Tonic R IGINKGO BILOBA, DIOSCOREA VILLOSA, GLYCYRRHIZA GLABRA, VISCUM ALBUM, PINUS SYLVESTRIS, APIS MELLIFICA, DULCAMARA, KALMIA LATIFOLIA, LYCOPODIUM CLAVATUM, SULPHURBioActive Nutritional, Inc.183e5794-76a4-450f-9686-7828e46855a32026-01-21WarningsExact identifier
unii: 70FD1KFU70
NeurotoxAGARICUS MUSCARIUS, COCCUS CACTI, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM CERIUM METALLICUM, CESIUM CHLORIDE, CHROMIUM, COBALTUM METALLICUM, CUPRUM METALLICUM, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, EUROPIUM METALLICUM, FERRUM METALLICUM, GADOLINIUM METALLICUM, GERMANIUM SESQUIOXIDE, HOLMIUM METALLICUM,BioActive Nutritional, Inc.73fb4038-40b5-4b5b-8ded-f510d0411c952026-01-21WarningsExact identifier
unii: 639KR60Q1Q
Naturasil Mite B Gone EXTREME BATH SOAKSULFURNature's Innovation, Inc.e94a0255-3ec1-4d68-93cf-80d4d7c99f7a2026-01-20WarningsExact identifier
unii: 70FD1KFU70
Acne Care LotnSALICYLIC ACIDSpa de Soleil0a90dd85-06d1-13e0-e063-6394a90af2b62026-01-20WarningsExact identifier
unii: 70FD1KFU70
Dairy AntigensCALCAREA CARBONICA, LAC DEFLORATUM, SEPIA, SULPHUR, AMERICAN CHEESE, CHEESE (STILTON), CHEESE (CAMEMBERT), CHEDDAR CHEESE, COTTAGE CHEESE, LAC CAPRINUM, LAC VACCINUM, SWISS CHEESEBioActive Nutritionald5e7f511-700e-40ec-a166-5688414e281f2026-01-20WarningsExact identifier
unii: 70FD1KFU70
END-ZITSULFURABBE Laboratories, Inc.afed5e8e-324c-44c6-abf6-72938376a4b22026-01-13WarningsExact identifier
unii: 70FD1KFU70
Sulfo loSULFUR 3% SOAP BARCrown Laboratories89577417-76a0-cb04-e053-2995a90a57332026-01-12WarningsExact identifier
unii: 70FD1KFU70
Arthritis ReliefARNICA MONTANA, BRYONIA ALBA, CHAMOMILLA,HYPERICUM PERFORATUM, KALMIA LATIFOLIA LEAF,KALMIA LATIFOLIA LEAFHomeocare Laboratories818cbfb4-b5f4-415c-ba9f-5305efe559532026-01-12WarningsExact identifier
unii: T7J046YI2B
COLD and FLU RELIEFCOLD AND FLU RELIEFClineva Management Services, LLC544c918d-86cc-1f8d-e054-00144ff8d46c2026-01-12WarningsExact identifier
unii: 639KR60Q1Q
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: T7J046YI2B
SODIUM SULFACETAMIDE AND SULFURSODIUM SULFACETAMIDE, SULFURBioComp Pharma, Inc.61e1497d-40ff-0c87-e053-2991aa0a29432026-01-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE AND SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.02acb079-f3b3-49f2-b1d9-4fc1553f72a92026-01-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
INFL CombinationACONITUM NAPELLUS, ADENOVIREN NOSODE, BRYONIA (ALBA), EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, INFLUENZINUM 2023-2024, IPECACUANHA, KREOSOTUM, VERATRUM VIRIDEDeseret Biologicals, Inc.d8d1d7b9-97f0-4b71-a589-af7c890a31602026-01-09WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Lung DrainageANTIMONIUM ARSENICICUM, BRYONIA (ALBA), CAMPHORA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, IPECACUANHA, KALI MURIATICUM, LOBELIA PURPURESCENS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, MYCOPLASMA PNEUMONIAE DNA, OXYGENIUM, PHOSPHORUS, PNEUMOCOCCINUM, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDEDeseret Biologicals, Inc.fd109172-46c3-444e-9fa0-124f785c3fb52026-01-09WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
E.O.L.STILLINGIA SYLVATICA, ZINCUM GLUCONICUM, THIAMINUM HYDROCHLORICUM, FRAGARIA VESCA, NICOTINAMIDUM, RHEUM (PALMATUM), SEROTONIN (HYDROCHLORIDE), 5-HYDROXYTRYPTOPHAN, BETAINUM MURIATICUM, BIOTIN, CHOLINUM, CYSTEINUM, DL-METHIONINE, L-ALANINE, L-CYSTINE, L-GLUTAMIC ACID, L-GLUTAMINE, L-LYSINE, L-METHIONINE, L-SERINE, PARA-AMINOBENZOIC ACID, POTASSIUM GLUCONATE, THYMUS (SUIS), THYROIDINUM (SUIS), UBIDECARENONUM, VITAMIN D3, DOPAMINE HYDROCHLORIDE, LITHIUM BROMATUM, SQUALENE, VACCINIUM MACROCARPON, OXYTOCIN,InLight Creation, LLC.b317d812-d6ed-4a2f-93f7-08b12261cc992026-01-09WarningsExact identifier
unii: U6WSN5SQ1Z
Metabolism ManagerASCLEPIAS VINCETOXICUM, ECHINACEA (ANGUSTIFOLIA), HYPOTHALAMUS SUIS, CEREBRUM SUIS, HEPAR SUIS, KIDNEY (SUIS), METHYLCOBALAMIN, PANCREAS SUIS, STOMACH (SUIS), AACG-A, AACG-B, CALCAREA CARBONICA, GAMBOGIA, GELSEMIUM SEMPERVIRENS, GRAPHITES, NUX VOMICA, PHYTOLACCA DECANDRA, 7-OXO-DEHYDROEPIANDROSTERONE-3BETA-ACETATE (7-KETO), ADENOSINUM TRIPHOSPHORICUM DINATRUM, INSULINUM (SUIS), SARCOLACTICUM ACIDUM, PROTEUS (VULGARIS)Healthsource of New England LLCa9662e0a-0a8b-4b0c-abe4-f3f4b6fbe7f82026-01-09WarningsExact identifier
unii: 639KR60Q1Q
Animal Pathogens Nosode Combination 9419ANIMAL PATHOGENS NOSODE COMBINATIONProfessional Complementary Health Formulas43b6ae2d-c089-4b81-bd15-0c66a84bbdbf2026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Pulsatilla Combination 9238PULSATILLA COMBINATIONProfessional Complementary Health Formulasaee2e5f5-8171-4a1a-8ea0-5d78ec22c8a82026-01-08WarningsExact identifier
unii: T7J046YI2B
Otitis Media Drops 2153OTITIS MEDIA DROPSProfessional Complementary Health Formulas9e8b60e9-0bd7-4c6c-99fa-cb87a9c831722026-01-08WarningsExact identifier
unii: 639KR60Q1Q

Reported adverse events (FAERS/openFDA)#

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