FDA.reportPublic FDA data

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 37 of 77 · 1,540 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BM177ARNICA MONT, BRYONIA ALB, CACTUS GRAND, FERR MET, RANANCULUS BULB, STANNUM METBestmade Natural Products2e7f950f-4080-7d05-e063-6294a90a92d92025-02-19WarningsExact identifier
unii: T7J046YI2B
Bestmade Natural Products BM180ACONITE NAP, ARGENTUM NIT, CHAMOMILLA, CYCLAMEN, GELSEMIUM, IGNATIA, MAG MUR, MOSCHUS, NUX VOMICABestmade Natural Products2e8259e9-087f-8e19-e063-6294a90ab0842025-02-19WarningsExact identifier
unii: 639KR60Q1Q
Bestmade Natural Products BM142ACID PHOS, ARNICA MONT, CICHORIUM INTY, ECHINACEA ANG, GINSENG, PAEONIA OFF, SARSAPARILLA, SULPHUR, TRITICUM REP, URTICA URENSBestmade Natural Products2e682051-2d61-1578-e063-6394a90a5e992025-02-18WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM149BERB VULG, BRYONIA ALB, CURCUMA LONGA, HYPERICUM, LYCOPODIUM, MENYANTHES, TARAXACUM, URTICA URENSBestmade Natural Products2e69eaf8-e02f-05c4-e063-6394a90a6fa02025-02-18WarningsExact identifier
unii: T7J046YI2B
Bestmade Natural Products BM151BELLADONNA, BENZOIC ACID, CAUSTICUM, EQUISETUM, GELSEMIUM, RHUS AROM, VERBASCUMBestmade Natural Products2e6a469d-026f-41b0-e063-6394a90abd792025-02-18WarningsExact identifier
unii: 639KR60Q1Q
Bestmade Natural Products BM152ACONITE, ANTI TART, BELLADONNA, CYCLAMEN, DULCAMARA, SULPHURBestmade Natural Products2e6aa8e8-22fa-687f-e063-6394a90a38022025-02-18WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM160AMYL NIT, FRAXINUS AM, GRAPHITES, MAG PHOS, MAG SULPH, PULSATILLA, SABINA, SULPHURBestmade Natural Products2e6cbe2b-9aad-f73e-e063-6294a90a5a532025-02-18WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM141AGARICUS MUS, HYDROCOTYLE, KALI CARB, SECALE CORN, SULPHUR, SYMPHYTUMBestmade Natural Products2e5abb73-ca66-ec0d-e063-6394a90a43cc2025-02-17WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM139ARNICA MONT, BRYONIA ALBA, COLCHICUM, CAUSTICUM, RANANCULUS BULB, RHODENDRON, RHUS TOXBestmade Natural Products2e1a4d9d-aa21-f82d-e063-6294a90ac9e62025-02-14WarningsExact identifier
unii: T7J046YI2B
Bestmade Natural Product BM132CADMIUM SULPH, CALC PIC, HELLIBORUS, PHYSOSTIGMA, GELSEMIUM, ZINCUM PHOSBestmade Natural Products2def5fb3-9be5-9738-e063-6294a90a7e4d2025-02-12WarningsExact identifier
unii: 639KR60Q1Q
Bryonia Alba 200ckBRYONIA ALBA ROOTSEVENE USAc8d49969-f04f-1605-e053-2a95a90a2fb32025-02-11WarningsExact identifier
unii: T7J046YI2B
Gelsemium Sempervirens 200ckGELSEMIUM SEMPERVIRENS ROOTSEVENE USAc8d62cad-5581-86ae-e053-2995a90a89872025-02-11WarningsExact identifier
unii: 639KR60Q1Q
SULPHUR 200ckSULPHURSEVENE USAcf8a0d33-999d-6860-e053-2995a90af8c62025-02-11WarningsExact identifier
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.9c5b8025-9c59-997e-e053-2a95a90ac6ce2025-02-11WarningsExact identifier
unii: T7J046YI2B
Stage Fright-FearACONITUM NAP., ANACARDIUM, ARG. NIT., ARSENICUM ALB., CYPRIPEDIUM, GELSEMIUM, IGNATIA, KALI CARB., LYCOPODIUM, NAT.MUR., PHOS., SAMBUCUS NIG., SEPIA, STAPHYSAG., STRAMONIUM, TARENTULA HISPANA, THERIDION, PASSIFLORA, VALERIANANewton Laboratories, Inc.2df84360-dfff-9851-e063-6394a90ad7902025-02-11WarningsExact identifier
unii: 639KR60Q1Q
unii: CT03BSA18U
Bestmade Natural Products BM128BAPTISIA, BELLADONNA, BRYONIA, ECHINACEA, TRITICUM REPBestmade Natural Products2dccd761-a81f-8b72-e063-6394a90aba642025-02-10WarningsExact identifier
unii: T7J046YI2B
Sciatica-Nerve CareACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA URNewton Laboratories, Inc.9cbd3056-3c1a-916d-e053-2a95a90aa2432025-02-10WarningsExact identifier
unii: T7J046YI2B
unii: CT03BSA18U
Sciatica-Nerve CareACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA URNewton Laboratories, Inc.9cbda496-ef30-18af-e053-2995a90a23212025-02-10WarningsExact identifier
unii: T7J046YI2B
unii: CT03BSA18U
RosaceaECHINACEA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, ARSENICUM BROMATUM, CARBO ANIMALIS, CAUSTICUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, KREOSOTUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, RHUS TOXICODENDRON, SEPIA, SULPHURNewton Laboratories, Inc.9caca164-0e81-7ed3-e053-2995a90a12442025-02-10WarningsExact identifier
unii: 70FD1KFU70
Sports RecoveryECHINACEA, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, APIS MELLIFICA, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CINCHONA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, LACTICUM ACIDUM, LEDUM PALUSTRE, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, STAPHYSAGRIA, SYMPHYTUM OFFICINALENewton Laboratories, Inc.9cd61789-fc2b-3d54-e053-2995a90a5a342025-02-10WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B

Reported adverse events (FAERS/openFDA)#

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