FDA.reportPublic FDA data

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 30 of 77 · 1,540 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Plantago PyritePLANTAGO PYRITEUriel Pharmacy Inc.ce4ca5f0-1760-400a-b9bb-6efa3420ba192025-09-16WarningsExact identifier
unii: T7J046YI2B
Cold Flu Relief BerryCOLD FLU RELIEF BERRYSchwabe North America03241f9f-8188-48ed-9177-42ef1e6c0fd62025-09-10WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Medique Cold EezeZINC GLUCONATEUnifirst First Aid Corporationa2b5f20a-87bf-731f-e053-2995a90a19522025-09-09WarningsExact identifier
unii: U6WSN5SQ1Z
RoyceDerm Rosacea Treatment Cream.SULPHUR 1X HPUS(10%)RoyceDerm LLC3df717fc-cf2f-8a9a-e063-6394a90ae4e22025-09-04WarningsExact identifier
unii: 70FD1KFU70
ColdCalm KidsSTRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, ONION, PHYTOLACCA AMERICANA ROOT, POTASSIUM DICHROMATE, GELSEMIUM SEMPERVIRENS ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, APIS MELLIFERA,Boiron6b3d8ff0-065d-85c4-e053-2991aa0a17882025-09-02Exact identifier
unii: 639KR60Q1Q
Hermon Balanitis CreamSULFUR 1X HPUSBeautivity LLC3dba4e4b-8224-6a96-e063-6394a90a91292025-09-01WarningsExact identifier
unii: 70FD1KFU70
InflammationANTHRACINUM, PYROGENIUM, ACONITUM NAP., ALOE, APIS MEL., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, FERRUM PHOSPHORICUM, GAULTHERIA PROCUMBENS, HEPAR SULPH. CALC., IODIUM, LACHESIS, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, VERATRUM VIRIDE, VERBASCUM, ECHINACEANewton Laboratories, Inc.9c1da6dd-5c6c-72c1-e053-2995a90a2f5a2025-08-27WarningsExact identifier
unii: T7J046YI2B
Cold Flu Relief Berry ChewablePELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUSSchwabe North America, Inc.fd62e45b-2f06-4146-af93-0eca805d06382025-08-25WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Cold Flu Relief OrangeCOLD FLU RELIEF ORANGESchwabe North America, Inc.2983e4bd-065a-4f9f-904f-4403361060962025-08-25WarningsExact 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.994cbc8e-a221-1548-e053-2995a90a1f7f2025-08-20WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Indigestion-GasCHAMOMILLA, 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.9c1c1525-9752-275d-e053-2a95a90acf432025-08-20WarningsExact identifier
unii: T7J046YI2B
Indigestion-GasCHAMOMILLA, 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.9c1cd511-64d4-3607-e053-2995a90a60292025-08-20WarningsExact identifier
unii: T7J046YI2B
Fungus FighterCANDIDA 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.93e05175-001b-c639-e053-2a95a90a289c2025-08-19WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
Fungus FighterCANDIDA 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.9b4276af-b738-3293-e053-2a95a90ad0222025-08-19WarningsExact identifier
unii: T7J046YI2B
unii: 70FD1KFU70
Natures Way Cold Flu Relief Fastactives Berry FlavoredPELARGONIUM SIDOIDES WHOLE, ACONITUM NAPELLUS WHOLE, EUCALYPTUS GLOBULUS LEAF, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM TOP, SEMPERVIRENS ROOT, PHOSPHORUS, IPECACUniversal Synergetics, Inc444081b1-c78f-4474-a084-e7bd2cc2eb3f2025-08-14WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Avar-e GreenSULFACETAMIDE SODIUM, SULFURMission Pharmacal Company9b2242b7-9672-450a-a257-9d45aab4a7062025-08-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Avar-e LSSULFACETAMIDE SODIUM, SULFURMission Pharmacal Companya92edd1d-a7ad-407c-a22c-592ab68f0a742025-08-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Ferrum QuartzFERRUM QUARTZUriel Pharmacy, Inc.052f687f-2263-9476-e063-6394a90a6ee92025-08-01WarningsExact identifier
unii: 70FD1KFU70
Pulmo BryoniaPULMO BRYONIAUriel Pharmacy Inc.a6752cc7-ff8c-4c34-a0a9-0658a915c8cc2025-08-01WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B

Reported adverse events (FAERS/openFDA)#

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