NDC 52053-0004-01 - 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
52053-0004
Requested NDC
52053-0004-01
Package NDCs from labels
52053-0004-2, 52053-0004-1, 52053-0004-01
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 72 of 76 · 1,511 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EdemaELAPS CORALLINUS, APIS MEL., ARSENICUM ALB., CANTHARIS, CINCHONA, COLCHICUM, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, JUNIPERUS COM., LACHESIS, MERC. VIV., NAJA, NAT. CARB., NAT.SULPHURICUM, RHUS TOXICODENDRON, SAMBUCUS NIG., STROPHANTHUS HISPIDUS, THUJA OCC., VIPERA BERUS, ECHINACEA, LAPPA, SOLIDAGO, TARAXACUM, URTICA UR.Newton Laboratories, Inc.98fbd4b0-43ac-098b-e053-2a95a90a66452020-12-03WarningsExact identifier
unii: CT03BSA18U
Eye FloatersALOE, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, CHOLESTERINUM, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, CYCLAMEN EUROPAEUM, GELSEMIUM SEMPERVIRENS, KALI CARBONICUM, MERCURIUS VIVUS, PHOSPHORUS, PHYSOSTIGMA VENENOSUM, PRUNUS SPINOSA, SENEGA OFFICINALIS, SEPIA, SULPHUR, TABACUM.Newton Laboratories, Inc.9a00f7a3-aa76-78ac-e053-2995a90a8c662020-12-03WarningsExact identifier
unii: 639KR60Q1Q
unii: 70FD1KFU70
ExhaustionACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.Newton Laboratories, Inc.98fc56b6-afed-2cfd-e053-2995a90a59ae2020-12-03WarningsExact identifier
unii: T7J046YI2B
FearACONITUM NAP., ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., CYPRIPEDIUM, GELSEMIUM, IGNATIA, KALI CARB., LYCOPODIUM, NAT.MUR., PHOSPHORUS, SAMBUCUS NIG., SEPIA, STAPHYSAG., STRAMONIUM, TARENTULA HISPANA, THERIDION, PASSIFLORA, VALERIANANewton Laboratories, Inc.99485faf-aee1-6482-e053-2a95a90a498b2020-12-03WarningsExact identifier
unii: 639KR60Q1Q
unii: CT03BSA18U
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9a61f1ae-d3a4-68d7-e053-2a95a90a43332020-12-03WarningsExact identifier
unii: C151H8M554
unii: 639KR60Q1Q
unii: 70FD1KFU70
FungalCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.99487f4a-76f6-407b-e053-2a95a90acfd42020-12-03WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
G-InflammCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, COLOCYNTHIS, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IPECACUANHA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MAGNESIA PHOSPHORICA, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9a153c45-0142-5abb-e053-2995a90a71f52020-12-03WarningsExact identifier
unii: T7J046YI2B
GlaucoACONITUM NAPELLUS, AURUM METALLICUM, BELLADONNA, CAUSTICUM, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, NUX VOMICA, OSMIUM METALLICUM, PHOSPHORUS, PHYSOSTIGMA VENENOSUM, RHUS TOXICODENDRON, SPIGELIA ANTHELMIA.Newton Laboratories, Inc.9a6394e7-14ed-ced1-e053-2995a90aeb882020-12-03WarningsExact identifier
unii: 639KR60Q1Q
Headache-MigraineELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.994a037b-7165-3a1e-e053-2a95a90ad7ff2020-12-03WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Herpes SoresARSENICUM ALB., BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CISTUS CANADENSIS, CONIUM, CROTON, DULCAMARA, GRAPHITES, KALI BIC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULSATILLA, RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR, THUJA OCC., ECHINACEA, HYPERICUMNewton Laboratories, Inc.99d9133b-6eea-511c-e053-2a95a90a74cb2020-12-03WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
Appetite - Craving ControlCHAMOMILLA, PASSIFLORA, VALERIANA, ANACARDIUM, ANTIMON. CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJ., DIGITALIS, GRAPHITES, HUMULUS, IRIS VERS., KALI CARB., LYCOPODIUM, NAT. CARB., NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS TOX., SCUTELLARIA, SEPIA, STRAMONIUMNewton Laboratories, Inc.98cf5293-2a47-5e15-e053-2995a90a9c3b2020-12-02WarningsExact identifier
unii: T7J046YI2B
Bact-InECHINACEA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, URTICA URENS, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, HYDRASTIS CANADENSIS, IODIUM, LACHESIS MUTUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, ANTHRACINUM, PYROGENIUMNewton Laboratories, Inc.9a9f61c8-1913-1e6d-e053-2a95a90a83562020-12-02WarningsExact identifier
unii: T7J046YI2B
Blad-RAPIS MEL., BERBER. VULG., BRYONIA, CANTHARIS, CINCHONA, EQUISETUM HYEMALE, FERRUM PHOSPHORICUM, GELSEMIUM, JUNIPERUS COM., PAREIRA, PHOSPHORUS, PLANTAGO, PULSATILLA, SABAL, TEREBINTHINA, UVA-URSI, ECHINACEA, HYDRASTIS, LAPPA, SOLIDAGONewton Laboratories, Inc.98cf954f-4b9e-c4ce-e053-2995a90a31d22020-12-02WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
BronCareECHINACEA, LAPPA, RUMEX CRISP., ANTIMON. TART., ARSENICUM ALB., BRYONIA, CAMPHORA, CHELIDONIUM MAJ., CINCHONA, DROSERA, EUCALYPTUS, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, IPECAC., KALI BIC., KALI CARB., KALI IOD., LYCOPODIUM, MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOS., PULSATILLA, SAINGUINARIA, SPONGIA, STANNUM MET., TUSSILAGO FAR., VERBASCUM, INFLUENZINUMNewton Laboratories, Inc.98d0c6e4-5825-0361-e053-2a95a90aaddd2020-12-02WarningsExact identifier
unii: T7J046YI2B
Breast Care - FibrocysticBUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUMNewton Laboratories, Inc.98d01128-9887-12ce-e053-2a95a90a73292020-12-02WarningsExact identifier
unii: T7J046YI2B
Childbirth CareARNICA MONTANA, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, PULSATILLA.Newton Laboratories, Inc.9a9fd3fb-7142-4620-e053-2a95a90a5e302020-12-02WarningsExact identifier
unii: 639KR60Q1Q
DiabaseCYNARA, ECHINACEA, IRIS VERS., THUJA OCC., URTICA UR., ARG. MET., ARSENICUM ALB., AUR. MET., BOVISTA, BRYONIA, CHELIDONIUM MAJ., CHIONANTHUS, GAULTHERIA, HELONIAS, IRIS VERS., LYCOPODIUM, NUX VOM., PHOS., RHUS TOX., SABAL, SYZYGIUMNewton Laboratories, Inc.9948bd7a-2ca2-272c-e053-2a95a90a4dc02020-12-02WarningsExact identifier
unii: T7J046YI2B
Distress-Mood-SadnessANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.98d0be75-9b50-1e15-e053-2995a90abf3b2020-12-02WarningsExact identifier
unii: 639KR60Q1Q
Distress-Mood-SadnessANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.98d08917-2f1b-4dc7-e053-2a95a90a1ce02020-12-02WarningsExact identifier
unii: 639KR60Q1Q
Dizzi-VABSINTHIUM, ACONITUM NAP., ANTIMON. TART., BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM, CONIUM, FERRUM METALLICUM, GELSEMIUM, GLONOINUM, HYOSCYAMUS, IPECAC., IRIS VERSICOLOR, LYCOPODIUM, NUX VOM., PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER, ECHINACEA, HYPERICUM, PASSIFLORA, VALERIANANewton Laboratories, Inc.987fa8d3-2ac8-5771-e053-2995a90adc2f2020-12-02WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B

Reported adverse events (FAERS/openFDA)#

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