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 39 of 76 · 1,511 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Poison IvyXEROPHYLLUM ASPHODELOIDES, ACONITUM NAP., ANACARDIUM ORIENTALE, APIS MEL., BRYONIA, CANTHARIS, CROTON, GRAPHITES, GRINDELIA, MEZEREUM, NUX VOM., RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP.,TARAXACUM, URTICA UR.Newton Laboratories, Inc.9c978687-b14b-46b1-e053-2995a90a13062025-02-07WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
Nervousness - AnxietyPASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, AMBRA GRISEA, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, ASAFOETIDA, BRYONIA, CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI PHOSPHORICUM, NUX VOMICA, SAMBUCUS NIGRA, STRYCHNINUM, THERIDION, VALERIANA OFFICINALIS.Newton Laboratories, Inc.9c94ff3a-2451-3617-e053-2a95a90a7cb92025-02-07WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: CT03BSA18U
Panic ButtonACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.Newton Laboratories, Inc.9b308f64-ba16-8b4f-e053-2995a90ac3ec2025-02-07WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
Panic ButtonACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.Newton Laboratories, Inc.9b3f50f3-1397-da75-e053-2995a90a340c2025-02-07WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
Pollen-WeedsGINKGO BILOBA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ADRENALINUM , ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, ARTEMISIA VULGARIS, BAPTISIA TINCTORIA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, DIOSCOREA VILOSA, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, KALI IODATUM, LACHESIS MUTUS, LILIUM TIGRINUM,Newton Laboratories, Inc.9c9a4de7-2eb0-240c-e053-2995a90a8b232025-02-07WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: CT03BSA18U
Pollen-WeedsGINKGO BILOBA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ADRENALINUM , ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, ARTEMISIA VULGARIS, BAPTISIA TINCTORIA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, DIOSCOREA VILOSA, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, KALI IODATUM, LACHESIS MUTUS, LILIUM TIGRINUM,Newton Laboratories, Inc.9caafbca-c8f7-d898-e053-2995a90a357a2025-02-07WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: CT03BSA18U
Sodium Sulfacetamide, SulfurSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.c735ff03-c97c-430d-a37b-5b40cf29046a2025-02-06Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Appetite - Craving ControlANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.Newton Laboratories, Inc.7964f0f7-7774-fac6-e053-2a91aa0a3e4a2025-02-06WarningsExact identifier
unii: T7J046YI2B
Tummy UpsetCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9dc307a2-4aa1-b02a-e053-2995a90a17882025-02-06WarningsExact identifier
unii: T7J046YI2B
Appetite - Craving ControlANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.Newton Laboratories, Inc.79655acc-f059-e509-e053-2a91aa0ac4882025-02-06WarningsExact identifier
unii: T7J046YI2B
Cold 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.9b952b77-d172-1828-e053-2a95a90ab4f62025-02-06WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
Dairy-Grain-NightshadesIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba83c60-35be-181a-e053-2a95a90a98952025-02-06WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.9bb84bae-9019-ed76-e053-2a95a90a5c3e2025-02-06WarningsExact identifier
unii: T7J046YI2B
Eczema - Skin CareANTIMON. CRUD., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR IOD., ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.Newton Laboratories, Inc.91d5dd26-ec17-3192-e053-2a95a90a20802025-02-06WarningsExact identifier
unii: T7J046YI2B
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba993f4-97af-4119-e053-2995a90a126d2025-02-06WarningsExact identifier
unii: T7J046YI2B
Fever - InfectionANTHRACINUM, INFLUENZA A VIRUS, INFLUENZA B VIRUS, PYROGENIUM, ACONITUM NAP., ANTIMON. TART., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, CINCHONA, EUPATORIUM PERF., FERRUM METALLICUM, GELSEMIUM, HEPAR SULPH.CALC., IODIUM, LACHESIS, MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALIX NIGRA, VERBASCUM, APIS MEL., ECHINACEA, HYDRASTISNewton Laboratories, Inc.8f023019-5c58-e0de-e053-2a95a90accfd2025-02-06WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Fever - InfectionANTHRACINUM, INFLUENZA A VIRUS, INFLUENZA B VIRUS, PYROGENIUM, ACONITUM NAP., ANTIMON. TART., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, CINCHONA, EUPATORIUM PERF., FERRUM METALLICUM, GELSEMIUM, HEPAR SULPH.CALC., IODIUM, LACHESIS, MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALIX NIGRA, VERBASCUM, APIS MEL., ECHINACEA, HYDRASTISNewton Laboratories, Inc.91e5f7cb-9055-4708-e053-2995a90abdfa2025-02-06WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Hangover HelpAGARICUS MUSC., ARSENICUM ALB., BISMUTHUM METALLICUM, BRYONIA, CAPSICUM, CARBO VEG., GLONOINUM, IPECAC., IRIS VERSICOLOR, LAUROCERASUS, LYCOPODIUM, MEZEREUM, NUX VOM., PULSATILLA, RANUNC. BULB. , THERIDION, VERATRUM ALB., ZINC. MET., ZINGIBER, CHAMOMILLA, PASSIFLORA, VALERIANANewton Laboratories, Inc.9bcce2ee-42c2-29cf-e053-2a95a90a36392025-02-06WarningsExact identifier
unii: T7J046YI2B
Hives-RashesANTIMON. CRUD., APIS MEL., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.Newton Laboratories, Inc.9c0a4d52-7d10-cc3b-e053-2a95a90a66972025-02-06WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
Hives-RashesANTIMON. CRUD., APIS MEL., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.Newton Laboratories, Inc.9c0a9375-d5f7-fe71-e053-2995a90a13b62025-02-06WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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