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 22 of 77 · 1,540 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COUGH BABYIPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOTHyland's Inc.2daac16d-69d0-48bf-806f-f22c0a6973ad2025-12-19WarningsExact identifier
unii: T7J046YI2B
Kids Cold and Cough DaytimeCALCIUM SULFIDE,GOLDENSEAL,ONION,PHOSPHORUS,PULSATILLA VULGARIS, SODIUM CHLORIDEHyland's Consumer Health Inc.e6118c79-b6d5-5c09-e053-2a95a90a30cf2025-12-19WarningsExact identifier
unii: 70FD1KFU70
4 KIDS COLD N COUGH GRAPE FLAVORONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFURHyland's Inc.798e2a4d-da2d-4bbd-a9b8-574490ef73572025-12-19WarningsExact identifier
unii: 70FD1KFU70
4 Kids Cold and Cough DaytimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.804e0e7a-20eb-128b-e053-2991aa0aa82c2025-12-19WarningsExact identifier
unii: 70FD1KFU70
4 Kids Cold and Cough Nighttime Natural Grape FlavorONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEANHyland's Inc.7923e59a-f62c-44df-e053-2991aa0afc1e2025-12-19WarningsExact identifier
unii: 70FD1KFU70
GUN POWDERPOTASSIUM NITRATE, ACTIVATED CHARCOAL, SULFURBoiron4653cf42-f61a-31a9-e063-6394a90a00a82025-12-19WarningsExact identifier
unii: 70FD1KFU70
AllergEaseALLIUM CEPA, APIS MELLIFICA, ARALIA RAC, ARUNDO, BAPTISIA, ECHINACEA, EUPHRASIA, GELSEMIUM, HISTAMINUM, LYCOPODIUM, RHUS TOX, SABADILLA, SANGUINARIA, URTICA UR.Eight and Company L.L.Cec4fae96-ffe3-489c-9ed2-4aaec114c4932025-12-18WarningsExact identifier
unii: 639KR60Q1Q
PlexionSULFACETAMIDE SODIUM, SULFURBrava Pharmaceuticals, LLC8211c8ec-b501-4ac6-8185-b4b9758cdc1a2025-12-18Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Tiny Tot Cough SyrupSQUILLA, ANTIMONIUM TART, ARSENICUM ALB, BELLADONNA, BRYONIA, CHAMOMILLA, CUPRUM MET, DROSERA, HEPAR SULPH CALC, IPECACUANHA, KALI BIC, KALI CARB, PHOSPHORUS, PULSATILLA, SPONGIANatural Creations, Inc38cc6bfc-c59f-4df1-9cff-10b3673b475a2025-12-18WarningsExact identifier
unii: T7J046YI2B
VIRAL HPARSENIC TRIOXIDE, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, LYCOPODIUM CLAVATUM SPORE, PHOSPHORIC ACID, PHOSPHORUS, RANCID BEEF, TOXICODENDRON PUBESCENS LEAFNatural Creations, Inc.95902493-0881-4a72-be53-2916648627cd2025-12-18WarningsExact identifier
unii: 639KR60Q1Q
Party ReliefARSENICUM ALB, AVENA, BRYONIA, CAPSICUM, CARBO AN, CARDUUS MAR, CHELIDONIUM MAJ, HEPAR SUIS, KALI IOD, LAPIS, RADIUM BROM, TARAXACUM, THUJA OCCEight and Company L.L.Cefadeae2-1ed9-4e80-9909-908bde98965b2025-12-18WarningsExact identifier
unii: T7J046YI2B
Vaccine Support CPBELLADONNA, CALCAREA CARBONICA, CARCINOSINUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MALANDRINUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PYROGENIUM, SARSAPARILLA, SILICEA, SULPHUR, THUJA OCCIDENTALISNatural Creations, Incb99f6b65-fe22-4dc2-97f8-8ab315396f752025-12-18WarningsExact identifier
unii: 70FD1KFU70
VIROSODEECHINACEA ANGUSTIFOLIA, HYDRASTIS CANADENSIS, LOMATIUM, PHYTOLACCA DECANDRA, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CARCINOSIN, COXSACKIE, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, HERPES ZOSTER, INFLUENZINUM, MORBILLINUM, PERTUSSIN, PYROGENIUMNatural Creations, Inc80b40e26-ce13-4027-bebc-c4bd6014e3ad2025-12-18WarningsExact identifier
unii: 639KR60Q1Q
Sodium Sulfacetamide, SulfurSULFACETAMIDE SODIUMBioComp Pharma, Inc.ed616ece-09b5-41d5-ae58-8e016da2c6b32025-12-17Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Stage Fight Acne MaskSULFUR, RESORCINOLBioelements, Inc21ca8de4-28b5-425f-e063-6394a90a33402025-12-17WarningsExact identifier
unii: 70FD1KFU70
Spot DefySULFURBioelements, Inc.6f35f950-8d04-4181-a897-5679fde1e2d92025-12-17WarningsExact identifier
unii: 70FD1KFU70
HZ-ChordBAPTISIA TINCTORIA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MEZEREUM, MORBILLINUM, NUX VOMICA, PALOONDO, PHYTOLACCA DECANDRA, SEPIA, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Energetix Corporation9685aec5-a65d-40fe-b5d7-2f13a69733bc2025-12-17WarningsExact identifier
unii: 639KR60Q1Q
LEG CRAMPS PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURWalgreen Companyd8c7ec58-5453-0e58-e053-2995a90abff12025-12-17WarningsExact identifier
unii: 70FD1KFU70
Walgreens Black Elderberry Cold and Flu ReliefBRYONIA ALBA, GELSEMIUM SEMPERVIRENS, SAMBUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUMWalgreen Co.d66d2e55-b76b-f88c-e053-2995a90a6e132025-12-17WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: 70FD1KFU70
unii: CT03BSA18U
unii: U6WSN5SQ1Z
Equate Yeast ReliefCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURWAL-MART STORES INCd96aa608-ed8a-36cd-e053-2a95a90ac2862025-12-17WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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