FDA.reportPublic FDA data

NDC 52053-0001-01 - 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
52053-0001
Requested NDC
52053-0001-01
Package NDCs from labels
52053-0001-1, 52053-0001-2, 52053-0001-4, 52053-0001-01
Manufacturer
PharmaCare US, Inc. | Apotheca Company
Effective date
2024-11-04
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 Company2024-11-04HUMAN OTC DRUG LABEL
Sambucol Cold and Flu ReliefPharmaCare US, Inc. | Nutritional Laboratories International Inc | Ion Labs Inc2022-04-12HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52053-0001-42023-07-28C16284748780-10191ceaa-6e4d-198a-e063-dbdaa90aec3eSambucol Cold and Flu Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52053-0001-1Sambucol Cold and Flu Relief4500 mg in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING450010
52053-0001-2Sambucol Cold and Flu Relief2 in 1 CARTONTABLET, ORALLY DISINTEGRATING210
52053-0001-4Sambucol Cold and Flu Relief6 in 1 CARTONTABLET, ORALLY DISINTEGRATING62
52053-0001-4Sambucol Cold and Flu Relief4500 mg in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING45002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52053-0001SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]10Current NDC, Legacy NDC, 2 package rows20241105_4dc2088f-3f13-4e49-83e4-44c2a26d195f.zip
52053-0001SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]2Current NDC, Legacy NDC, 2 package rows20220413_ce66e57d-ae46-0973-e053-2a95a90a6165.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2BSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1QSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
SAMBUCUS NIGRA FLOWERING TOPACTIVE INGREDIENTCT03BSA18USAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
SULFURACTIVE INGREDIENT70FD1KFU70SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
ZINC GLUCONATEACTIVE INGREDIENTU6WSN5SQ1ZSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2BSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1QSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
SAMBUCUS NIGRA FLOWERING TOPACTIVE MOIETYCT03BSA18USAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
SULFURACTIVE MOIETY70FD1KFU70SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
BLACK CARROT ANTHOCYANINSINACTIVE INGREDIENT971DA56IOLSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
EUROPEAN ELDERBERRY JUICEINACTIVE INGREDIENTZ4IFJ0AK1ESAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1

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 9 of 78 · 1,546 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Sulfacetamide 10% and Sulfur 5% CleanserSODIUM SULFACETAMIDE 10% AND SULFUR 5%Oncor Pharmaceuticalsf5fecb2b-52d7-4373-b432-ad23aa93085e2026-03-22Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SUFLUR SPOTandMASK Acne Clearing Treatment MaskSULFURCA-Botana International4d77310a-2441-a17e-e063-6394a90ae68b2026-03-20WarningsExact identifier
unii: 70FD1KFU70
CHESTAL COUGH AND MUCUSANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS WHOLE, RUMEX CRISPUS ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIABoiron4d77a058-e6c8-2af5-e063-6394a90afe1a2026-03-20WarningsExact identifier
unii: T7J046YI2B
SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient CreamSODIUM SULFACETAMIDE 10% AND SULFUR 5% EMOLLIENT CREAMBryant Ranch Prepack4ebfcaae-a375-45aa-a7f9-2b622f564f022026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10% and Sulfur 2% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack5dbcde27-8c20-4ecc-81f7-117e0b0cadf32026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Flu-ColdECHINACEA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, PHOSPHORUS, PYROGENIUM, RHUS TOXICODENDRONNatural Wonders46f674d1-8a50-4ebe-a0db-d539b75d91292026-03-19WarningsExact identifier
unii: 639KR60Q1Q
Sodium Sulfacetamide 9% and Sulfur 4.5% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack25516616-2249-4b4f-be31-1a4378d038612026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 8% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepackfb0c9508-0ff1-46eb-8df0-4bfd2c1231872026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack5ddd93cf-cfeb-460c-b2c5-83f501ef9ab92026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
dermveda ULTRA EYE REMEDYSULPHUR, CURCUMA LONGACelcius Corp.1088f138-dacb-4a7b-a623-c49e41bccb672026-03-18WarningsExact identifier
unii: 70FD1KFU70
Lymph Tonic IIIADENOSINUM TRIPHOSPHORICUM DINATRUM, ARNICA MONTANA, BOLDO, CALCAREA IODATA, CALCAREA PHOSPHORICA, CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), GERMANIUM SESQUIOXIDE, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM (2024-2025), NAJA TRIPUDIANS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, PYROGENIUM, SULPHUR, THYROIDINUM (SUIS), UBIDECARENONUMBioActive Nutritional, Inc.14f87aa6-2005-4939-a612-1162bbc5462b2026-03-18WarningsExact identifier
unii: 70FD1KFU70
Naturasil Mite B Gone 5 oz 2 packSULFUR, THUJA OCCIDENTALISNature's Innovation, Inc.f12c4a7b-75ed-46e6-a0dd-b119538729c72026-03-17WarningsExact identifier
unii: 70FD1KFU70
DrainageECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHURBioActive Nutritional, Inc.7e573986-60c2-40df-9e28-e7f1d9fe1a992026-03-13WarningsExact identifier
unii: 70FD1KFU70
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
LigatoneARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEABioActive Nutritional, Inc.3a3bdd55-daec-43b9-a380-54a747fb7d102026-03-13WarningsExact identifier
unii: T7J046YI2B
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: 70FD1KFU70
Restless Leg Symptom ReliefARSENICUM ALBUM, BUFO RANA, CAUSTICUM, CHAMOMILLA, CROTALUS HORRIDUS, DIGITALIS PURPUREA, LACHESIS MUTUS, LILIUM TIGRINUM, PULSATILLA, RHUS TOX, SULPHUR, TARENTULA HISPANA, VISCUM ALBUM AND ZINCUM METALLICUM.King Bio Inc.07ab09eb-9430-4ea2-90c0-db2ca237cc962026-03-10WarningsExact identifier
unii: 70FD1KFU70
Menopause ReliefAMYL NIT, CALC CARB, CAULOPHYLLUM, CIMICIFUGA, FERRUM MET, GELSEMIUM, LACHESIS, PULSATILLA, SANGUINARIA, SEPIA, SULPHUR AND SULPHURICUM AC.King Bio Inc.e12b75f5-6c5f-4b39-a6aa-dad07089f1d82026-03-10WarningsExact identifier
unii: 639KR60Q1Q
unii: 70FD1KFU70
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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