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 58 of 76 · 1,511 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gun powderPOTASSIUM NITRATE, ACTIVATED CHARCOAL, SULFURBoiron85cb268d-43b4-3c6e-e053-2991aa0a050f2023-11-13Exact identifier
unii: 70FD1KFU70
The INKEY List Acne Clearing MoisturizerSULFURBrand Evangelists for Beauty Limitedd26f5031-6592-4467-afc9-41c21f9f048c2023-11-10WarningsExact identifier
unii: 70FD1KFU70
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.99eb7b5d-926d-aa16-e053-2a95a90a08342023-11-07WarningsExact identifier
unii: T7J046YI2B
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.9c31d465-caac-3a02-e053-2a95a90adb3b2023-11-03WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
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.9c1edd83-5269-1363-e053-2a95a90a24dc2023-11-03WarningsExact identifier
unii: T7J046YI2B
AnxietyACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, CARCINOSIN, CAUSTICUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NITRICUM ACIDUM, PHOSPHORUS, RHUS TOXEnergique, Inc.2fd7051b-d274-4028-8348-b175a22f045c2023-11-03WarningsExact identifier
unii: 639KR60Q1Q
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.9c4a13c3-87ff-e833-e053-2995a90a8aba2023-11-02WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
VermistatARTEMISIA VULGARIS, CINA, SABADILLA, SPIGELIA ANTHELMIA, FILIX MAS, BARYTA CARBONICA, CALCAREA CARBONICA, SULPHUR, TEREBINTHINAEnergique, Inc.c71d80f4-c362-432d-83dd-2233e18b8dd42023-11-02WarningsExact identifier
unii: 70FD1KFU70
VermistatARTEMISIA VULGARIS, CINA, SABADILLA, SPIGELIA ANTHELMIA, FILIX MAS, BARYTA CARBONICA, CALCAREA CARBONICA, CINCHONA OFFICINALIS, NATRUM PHOSPHORICUM, SULPHUR, TEREBINTHINA, PROTEUS (VULGARIS)Energique, Inc.acb43b1a-52fd-484b-96a8-1cfe97c1f3982023-11-02WarningsExact identifier
unii: 70FD1KFU70
Mineffect skin protectantALUMINA, CALCAREA SILICATA, MAGNESIA SULPHURICA, SILICEA, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltd84a86989-bb7c-4f96-8cc0-d676264845322023-10-31WarningsExact identifier
unii: 70FD1KFU70
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: 70FD1KFU70
Mineffect facial skin protectant and acne treatment solutionALUMINA, CALCAREA SILICATA, FERRUM METALLICUM, MAGNESIA SULPHURICA, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltdf6b3ea92-2382-4c3f-8ed9-31ea26fd47ee2023-10-31WarningsExact identifier
unii: 70FD1KFU70
Mineffect hangover reliefALUMINA SILICATA, CALCAREA SILICATA, SILICEA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, FERRUM MURIATICUM, SULPHUR, PHOSPHORUSKadesh Incoporation Co,Ltdc9821e87-1e8d-48ab-8821-32e7e660309a2023-10-31WarningsExact identifier
unii: 70FD1KFU70
Mineffect first aid antiseptic and antibiotic solutionSILICEA, SULPHUR, PHOSPHORUS, CALCAREA SILICATA, NATRUM NITRICUM, FERRUM MURIATICUM, KALI SILICATUMKadesh Incoporation Co,Ltd9bd266bb-7078-413f-8fc9-6423535891302023-10-31WarningsExact identifier
unii: 70FD1KFU70
Mineffect cold remedyCALCAREA FLOURICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, SILICEA, SULPHUR, ZINCUM METALLICUMKadesh Incoporation Co,Ltd14d2a1fe-a1f1-4e85-96c0-d8b90260336c2023-10-31WarningsExact identifier
unii: 70FD1KFU70
Ahh SleepCOFFEA CRUDAMicro Balance Health Products08ea860f-0183-8ce8-e063-6394a90a582b2023-10-30WarningsExact identifier
unii: 70FD1KFU70
Glovers Anti-DandruffSULFUR, SALICYLIC ACIDJ. Strickland & Co.49fd4e03-736c-429a-8972-7302b732f8162023-10-21WarningsExact identifier
unii: 70FD1KFU70
Glovers Dandruff Control Med., FloralSULFURJ. Strickland & Co.a1224e4a-e811-4415-a038-3933da43d8192023-10-21WarningsExact identifier
unii: 70FD1KFU70
Sulfur 8 Light Anti-Dandruff Hair and Scalp ConditionerSULFURJ. Strickland & Co.d8f9afe8-bc44-41be-806b-b77d2def0fb02023-10-21WarningsExact identifier
unii: 70FD1KFU70
Glovers Dandruff Control Medicine, RegularSULFURJ. Strickland & Co.18700036-11ec-4370-bcc6-b9e2c732e7d92023-10-21WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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