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 2 of 77 · 1,540 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hylands Naturals Earache DropsBELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFURHyland's Inc.017ed754-9fe8-2cb5-e063-6294a90ab2f62026-08-24WarningsExact identifier
unii: 70FD1KFU70
Cold Crush AdultACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, NUX VOMICA, PULSATILLA, RHUS TOXICODENDRON, SABADILLAGenexa Inc.78ff93d3-5c77-b951-e053-2a91aa0adda92026-08-22WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
EdemaforceCACTUS GRANDIFLORUS, CALENDULA OFFICINALIS, DULCAMARA, LEPTANDRA VIRGINICA, SOLIDAGO VIRGAUREA, CONVALLARIA MAJALIS, APIS MELLIFICA, ARNICA MONTANA, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PLUMBUM METALLICUM, SAMBUCUS NIGRABioActive Nutritional, Inc.5e7d1909-932a-41a3-bad3-be320bb9ef352026-08-20WarningsExact identifier
unii: T7J046YI2B
unii: CT03BSA18U
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: 70FD1KFU70
Naturasil Tinea Versicolor ReliefSULFURNature's Innovation, Inc.255f4fdb-bcc5-45e2-b9bd-06908bfbe23b2026-08-19WarningsExact identifier
unii: 70FD1KFU70
Cold Comfort Cold and CoughALLIUM CEPA 5C, EUPHRASIA OFFICINALIS 5C, HYDRASTIS CANADENSIS 5C, NUX VOMICA 5C, PULSATILLA 5C, RUMEX CRISPUS 5C,SABADILLA 5C, SAMBUCUS NIGRA 5CSEVENE USA54e9282a-604d-4acd-e063-6394a90a59ff2026-08-18WarningsExact identifier
unii: CT03BSA18U
BM BM104 DROPSCALC FLUOR, CHIMAPHILA, FERR PHOS, HYDRANGEA, KALI PHOS, SAW PALMETTO, SULPHURBM Private Limited5900caa3-e5b2-54d7-e063-6294a90adac22026-08-14WarningsExact identifier
unii: 70FD1KFU70
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: 70FD1KFU70
BM BM194 DROPSARGENTIUM NIT, CAUSTICUM, GELSEMIUM SEMP, MERC SOL, RAUWOLFIA SERPBM Private Limited5903a5cf-ecd3-e775-e063-6394a90a2e0a2026-08-14WarningsExact identifier
unii: 639KR60Q1Q
Calm mind Stress - Nervousness - Anxiety - ConcentrationACONITUM NAPELLUS 9C, CHAMOMILLA 9C, GELSEMIUM SEMPERVIRENS 9C, IGNATIA AMARA 9C, PASSIFLORA INCARNATA 3C, STRAMONIUM 9CSEVENE USA551125a8-b6ed-f9f4-e063-6294a90a4c412026-08-13WarningsExact identifier
unii: 639KR60Q1Q
Natural Lift Lack of energy - FatigueAVENA SATIVA 9C, GELSEMIUM SEMPERVIRENS 9C, PANAX GINSENG 3C, NATRUM MURIATICUM 9CSEVENE USA551194c4-dfd8-c42d-e063-6294a90aecee2026-08-13WarningsExact identifier
unii: 639KR60Q1Q
BM BM53 DROPSAPIS MELLIFICA, APIUM VIRUS, ARSENIC ALB., BRYONIA ALBA, SULPHURBM Private Limited58eeb0eb-d09a-b979-e063-6394a90ad84d2026-08-13WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
BM BM59 DROPSCALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBM Private Limited58ef0755-c2cd-b7c2-e063-6294a90a27072026-08-13WarningsExact identifier
unii: 70FD1KFU70
CVS Health Cold Remedy Lemon FlavorZINCUM GLUCONICUMCVS PHARMACY, INC6de9d527-1234-4d1c-90a8-5032ead872962026-08-13WarningsExact identifier
unii: U6WSN5SQ1Z
CVS Health Cold Remedy Citrus FlavorZINC GLUCONATECVS PHARMACY, INCd32dedd1-8db8-427e-a925-fe5ebb5498802026-08-13WarningsExact identifier
unii: U6WSN5SQ1Z
CVS Health Cold Remedy Cherry FlavorZINCUM GLUCONICUMCVS PHARMACY, INCd4937e77-f932-4994-945c-2a1699e9481e2026-08-13WarningsExact identifier
unii: U6WSN5SQ1Z
CVS Health Cold Remedy Orange Cream FlavorZINCUM GLUCONICUMCVS PHARMACY, INCf0122ffc-560d-45db-9a75-9220cc5aac452026-08-13WarningsExact identifier
unii: U6WSN5SQ1Z
Spot CorrectionSULFURHydroPeptide LLC45ec40ff-7134-085b-e054-00144ff8d46c2026-08-12WarningsExact identifier
unii: 70FD1KFU70
GLP SupportABIES NIGRA, ABROTANUM (ARTEMISIA ABROTANUM), ANTIMONIUM CRUDUM, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANTHARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, FEL TAURI, IRIS VERSICOLOR, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NUX VOMICA, PANCREAS SUIS, PHOSPHORUS, SECALE CORNUTUMDeseret Biologicals, Inc.e9d189fa-dbb5-424f-9c5a-8aafc805c5b22026-08-11WarningsExact identifier
unii: T7J046YI2B
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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