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 23 of 77 · 1,540 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olive-ViateTOPICAL SKIN RELIEFVitality Works, Inc.443819f6-8608-4790-a6ec-ad9d568d75ce2025-12-17WarningsExact identifier
unii: 70FD1KFU70
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: T7J046YI2B
Stop RashADULT SKIN RELIEFVitality Works, Inc.eac4daac-591c-400d-a640-4440f67906712025-12-17WarningsExact identifier
unii: 70FD1KFU70
Cal-5-ReviveCALCIUM BALANCEVitality Works, Inc.a642c238-dacc-41a0-8590-ca466eb297892025-12-17WarningsExact identifier
unii: U6WSN5SQ1Z
Sore Muscle and Joint ReliefMUSCLE AND JOINT REMEDYVitaltiy Works, Inc.3cd12d22-0fae-4a00-b026-c574e80352782025-12-17WarningsExact identifier
unii: T7J046YI2B
PSORIASIS HPARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUMNatural Creations, Inc.d2522637-fd16-4246-90d8-f90fb224550e2025-12-16WarningsExact identifier
unii: 70FD1KFU70
Renu Laboratories Acne Sulphur LACNE SULFUR LOTIONRenu Laboratories, LLC13de0e4c-b134-41c0-e054-00144ff88e882025-12-16WarningsExact identifier
unii: 70FD1KFU70
HivesECHINACEA ANG, APIS MEL, ARSENICUM ALB, CARBOLICUM AC, LEDUM, RHUS TOX, SULPHUR, URTICA URENSNatural Creations, Incc453ac40-1865-4297-b7d4-c8e637bb5f942025-12-16WarningsExact identifier
unii: 70FD1KFU70
Sleepy Time CPACONITUM, ARSENICUM ALB, CALC CARB, COFFEA CRUDA, MAGNESIUM MET, NUX VOM, PULSATILLA, SEPIA, SULPHURNatural Creations, Inc03cbb408-7e2a-49e8-b83a-b8d932a104592025-12-16WarningsExact identifier
unii: 70FD1KFU70
InjuryCALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA ALBA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, STAPHYSAGRIA, PYROGENIUMNatural Creations, Incb4b850fb-6fdd-47b7-8a6e-2e596ec6256c2025-12-16WarningsExact identifier
unii: T7J046YI2B
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: 70FD1KFU70
RespirasodeBRYONIA, DULCAMARA, KALI CARB, SANGUINARIA, BELLADONNA, BROMIUM, CANDIDA ALB, CANDIDA PARAP, CONIUM, LYCOPODIUM, PULSATILLA, SECALE, SILICEA, STICTA, SULPHUR, USTILAGO MAIDISNatural Creations, Incce06327f-7e5e-420a-9b61-0d410f9e10d62025-12-16WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
COLD EEZEZINC GLUCONATEJHK Inc dba American Safety & First Aide6e729c0-90ee-410e-b425-9c19e3333a242025-12-16WarningsExact identifier
unii: U6WSN5SQ1Z
DRx Blemish Clarifying MaskSULFURDr. Dennis Gross Skincare7093a8d4-1910-4b23-9d88-d3398db0916a2025-12-15WarningsExact identifier
unii: 70FD1KFU70
Fibromyalgia ReliefBRYONIA ALBA ROOT - CAUSTICUM - LOESELIA MEXICANA WHOLE - MAGNESIUM PHOSPHATE - PULSATILLA VULGARIS - TOXICODENDRON PUBESCENS LEAF - VALERIANTRP Companya6ba3058-ec39-715f-e053-2995a90aa32a2025-12-15WarningsExact identifier
unii: T7J046YI2B
Asthma TherapyARSENIC TRIOXIDE - HISTAMINE DIHYDROCHLORIDE - DERMATOPHAGOIDES PTERONYSSINUS - MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - STRYCHNOS NUX-VOMICA SEED - ASPIDOSPERMA QUEBRACHO-BLANCO BARK - SUPLHUR -TRP Company07d2988b-5012-481c-9b48-a709c33d29792025-12-15WarningsExact identifier
unii: 70FD1KFU70
Migraine Headache TherapyATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE -TRP Company317d3f42-783e-02b7-e054-00144ff88e882025-12-15WarningsExact identifier
unii: T7J046YI2B
ComPare2 Black Elderberry Cold and Flu ReliefBRYONIA, GELSEMIUM SEMPERVIRENS, SAMBUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUMTRP COMPANYa6231fe1-1f0f-04c8-e053-2a95a90a6ee72025-12-15WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: 70FD1KFU70
unii: CT03BSA18U
unii: U6WSN5SQ1Z
Irritable Bowel Syndrome TherapyASAFETIDA - BISMUTH SUBNITRATE - BRYONIA ALBA ROOT - ACTIVATED CHARCOAL - LYCOPODIUM CLAVATUM SPORE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - VERATRUM ALBUM ROOT -TRP Company04149220-c7ce-4312-9630-f93d6def3aaa2025-12-15WarningsExact identifier
unii: T7J046YI2B
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: T7J046YI2B
unii: U6WSN5SQ1Z

Reported adverse events (FAERS/openFDA)#

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