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 28 of 77 · 1,540 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a29037-8c13-25e2-e053-2a91aa0a08452025-10-24Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a2aa5a-29cc-6ef2-e053-2a91aa0a019c2025-10-24Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a29d28-b47b-e877-e053-2991aa0ac0492025-10-24Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a2ce33-bfb9-b8a9-e053-2a91aa0ae3ca2025-10-24Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a33d3e-7194-a722-e053-2a91aa0a760f2025-10-24Exact identifier
unii: 639KR60Q1Q
Naturasil Sulfur-LavenderSULFURNature's Innovation, Inc.e75cbce9-3791-4572-9359-8049d6ce9beb2025-10-22WarningsExact identifier
unii: 70FD1KFU70
Sambucus Cold Flu Relief ElderberryPELARGONIUM SIDOIDES ROOT, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA FLOWERING TOP, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECACSchwabe North America, Inc.aaa28ba9-6abd-46da-8ffa-83178505aeee2025-10-22WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: CT03BSA18U
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
DERMOSCRIBE SEBORRHEIC DERMATITISSULFUR, SALICYLIC ACID, HYDROCORTISONEDERMOSCRIBE PTY LTD2b6bf90b-5d42-4c08-afee-56e13122285e2025-10-17WarningsExact identifier
unii: 70FD1KFU70
Cedar X FormulaOLIBANUM, THUJA OCCIDENTALIS, GELSEMIUM SEMPERVIRENS, ALLIUM CEPA, ANTIMONIUM TARTARICUM, HEPAR SULPHURIS CALCAREUM, JUNIPERUS COMMUNIS.Integrative Healing Institute, LLC8ab87e13-99ad-4b25-a0c3-e46a868cc6842025-10-17WarningsExact identifier
unii: 639KR60Q1Q
Mold Relief FormulaKALI MURIATICUM, GELSEMIUM, KALI BICHROMICUM, SABADILLA, HISTAMINUM, MOLD MIX.Integrative Healing Institute, LLC067ee707-7219-4370-9cdd-08888f45b5e52025-10-17WarningsExact identifier
unii: 639KR60Q1Q
Seasonal Allergy FormulaHYDRASTIS CANADENSIS, KALI MURIATICUM, GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, SABADILLA, HISTAMINUM, HOUSE DUST, GRASS MIX, TREES MIX, WEEDS MIXIntegrative Healing Institute, LLC1d4deee9-5452-421b-a107-ab150d1f62142025-10-17WarningsExact identifier
unii: 639KR60Q1Q
SEACALL NAIL REVIVE SERUMNAIL REVIVE SERUMGuangdong Quadrant Ecological Technology Co., Ltd.1f4d0c9a-361e-72e5-e063-6394a90a7cda2025-10-15WarningsExact identifier
unii: 70FD1KFU70
PlexionSULFACETAMIDE SODIUM, SULFURCintex Services, LLC41365fd6-0865-fa55-e063-6294a90a83532025-10-15Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE, SULFURCintex Services, LLC4137736e-7c9e-94e0-e063-6294a90ac97c2025-10-15Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE, SULFURCintex Services, LLC413746d8-5469-3f62-e063-6294a90af82c2025-10-15Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9.8% and Sulfur 4.8% CleanserSULFACETAMIDE SODIUM, SULFURCintex Services, LLC4137a6a5-35f4-ad2a-e063-6394a90aac192025-10-15Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide and Sulfer EmulsionSODIUM SULFACETAMIDE AND SULFERTrifluent Pharma40601d03-aea0-b0a6-e063-6394a90a16982025-10-15Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Stage Fight Acne MaskSULFUR, RESORCINOLCosmetic Enterprises Ltd209e321e-ed20-9c67-e063-6394a90a54102025-10-14WarningsExact identifier
unii: 70FD1KFU70
Larynx LevisticumLARYNX LEVISTICUMUriel Pharmacy Inc.8db7f52e-648f-4208-8784-ef2a662fe7902025-10-10WarningsExact identifier
unii: T7J046YI2B

Reported adverse events (FAERS/openFDA)#

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