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 38 of 76 · 1,511 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Restless LegMYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORANewton Laboratories, Inc.9b2e2194-fda3-6837-e053-2995a90ac61a2025-02-10WarningsExact identifier
unii: 639KR60Q1Q
Restless LegMYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORANewton Laboratories, Inc.9b3f076e-7edd-ea51-e053-2a95a90abd9b2025-02-10WarningsExact identifier
unii: 639KR60Q1Q
Just In CaseACONITUM NAPELLUS, ARNICA MONTANA, BRYONIA, ECHINACEA, LEDUM PALUSTRE, ARSENICUM ALBUM, CENCHRIS CONTORTRIX, CROTALUS CASCAVELLA, CROTALUS HORRIDUS, LACHESIS MUTUS, MERCURIUS CORROSIVUS, NAJA TRIPUDIANS, PHOSPHORUS, TOXICOPHIS PUGNAX, VIPERA BERUS, ELAPS CORALLINUS, HELODERMA.Newton Laboratories, Inc.a035f2bf-2f5d-0a50-e053-2995a90a8d9c2025-02-10WarningsExact 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.99fdc906-3a55-e4c4-e053-2a95a90a76ba2025-02-10WarningsExact identifier
unii: T7J046YI2B
Gas-IndigestionCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, DAPHNE INDICA, IPECACUANHA, IRIS VERSICOLOR, KALI CARBONICUM, KREOSOTUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, SPIGELIA ANTHELMIA, SULPHUR, PYROGENIUMNewton Laboratories, Inc.9a125a53-39c2-d849-e053-2a95a90a98452025-02-10WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
Bestmade Natural Products BM120ABROMA AUGUSTA, ABROMA RADIX, ALETRIS FARINOSA, GELSEMIUM, IGNATIA, LILIUM TIG, VIBUR OPULBestmade Natural Products2d925b1e-668f-a959-e063-6294a90a35142025-02-07WarningsExact identifier
unii: 639KR60Q1Q
Leg Cramps-SwellingECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPSNewton Laboratories, Inc.9c315126-e61e-f649-e053-2a95a90a7f082025-02-07WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0cd92b-905d-f90f-e053-2995a90a47052025-02-07WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0d8c82-6c4f-a511-e053-2995a90a793f2025-02-07WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Lymphatic CareECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..Newton Laboratories, Inc.9c3507de-1def-4019-e053-2a95a90a14752025-02-07WarningsExact identifier
unii: T7J046YI2B
Lymphatic CareECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..Newton Laboratories, Inc.9c36201a-2153-0600-e053-2995a90a6bbf2025-02-07WarningsExact identifier
unii: T7J046YI2B
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4872fd-bfe5-2472-e053-2995a90a361f2025-02-07WarningsExact identifier
unii: T7J046YI2B
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4718ef-86ac-7bb7-e053-2a95a90a56272025-02-07WarningsExact identifier
unii: T7J046YI2B
Morning Sickness-NauseaCHAMOMILLA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, BISMUTHUM METALLICUM, BRYONIA, CIMICIFUGA RACEMOSA, GOSSYPIUM HERBACEUM, IPECACUANHA, KREOSOTUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PULSATILLA, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c4a6bf8-5f48-96a8-e053-2a95a90a97572025-02-07WarningsExact identifier
unii: T7J046YI2B
Menstrual - PMSANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, DIOSCOREA, FOLLICULINUM, GELSEMIUM, LACHESIS, LILIUM, LYCOPODIUM, MILLEFOLIUM, NUX VOM., PULSATILLA, SABINA, SECALE, SEPIA,THLASPI, VIBURNUM OP., ZINGIBER, ECHINACEA, VALERIANANewton Laboratories, Inc.9c496655-8a6a-47e2-e053-2a95a90a7f012025-02-07WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Motion SicknessECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ABSINTHIUM, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM AUTUMNALE, CONIUM MACULATUM, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, GLONOINUM, HYOSCYAMUS NIGER, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c5a4018-0231-e92b-e053-2995a90a40162025-02-07WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Motion SicknessECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ABSINTHIUM, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM AUTUMNALE, CONIUM MACULATUM, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, GLONOINUM, HYOSCYAMUS NIGER, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c592084-9412-c00b-e053-2a95a90a57902025-02-07WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
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.9c9999b9-8d48-67f7-e053-2995a90aac962025-02-07WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
Muscle EaseCHAMOMILLA, PHYTOLACCA DECANDRA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, ARGENTUM NITRICUM, ARNICA MONTANA, BRYONIA, CHAMOMILLA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, EUPATORIUM PERFOLIATUM, HYPERICUM PERFORATUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, STRAMONIUM, STRYCHNINUM.Newton Laboratories, Inc.9c5a4018-0230-e92b-e053-2995a90a40162025-02-07WarningsExact identifier
unii: T7J046YI2B
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.9c5db752-11bb-01c0-e053-2a95a90aa7312025-02-07WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: CT03BSA18U

Reported adverse events (FAERS/openFDA)#

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