Sambucol Cold and Flu Relief

Product NDC
52053-0001
Requested package NDC
52053-0001-2
11-digit product format
520530001
Labeler code
52053
Product ID
52053-0001_bf3dfdcd-0427-46ad-aa29-60e5b1fa0089
Type
HUMAN OTC DRUG
Nonproprietary name
Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
PharmaCare US, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-03-26
Substance
BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; ZINC GLUCONATE
Active strength
6; 6; 3; 12; 2 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sambucol Cold and Flu Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRYONIA ALBA ROOT6 [hp_X]/mg
GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]/mg
SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]/mg
SULFUR12 [hp_X]/mg
ZINC GLUCONATE2 [hp_X]/mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T7J046YI2BInternal UNII lookup
639KR60Q1QInternal UNII lookup
CT03BSA18UInternal UNII lookup
70FD1KFU70Internal UNII lookup
U6WSN5SQ1ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4dc2088f-3f13-4e49-83e4-44c2a26d195fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52053-0001-42023-07-28C16284748780-10191ceaa-6e4d-198a-e063-dbdaa90aec3eSambucol Cold and Flu Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52053-0001-1Sambucol Cold and Flu Relief4500 mg in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING450010
52053-0001-2Sambucol Cold and Flu Relief2 in 1 CARTONTABLET, ORALLY DISINTEGRATING210
52053-0001-4Sambucol Cold and Flu Relief6 in 1 CARTONTABLET, ORALLY DISINTEGRATING62
52053-0001-4Sambucol Cold and Flu Relief4500 mg in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING45002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2BSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1QSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
SAMBUCUS NIGRA FLOWERING TOPACTIVE INGREDIENTCT03BSA18USAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
SULFURACTIVE INGREDIENT70FD1KFU70SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
ZINC GLUCONATEACTIVE INGREDIENTU6WSN5SQ1ZSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2BSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1QSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
SAMBUCUS NIGRA FLOWERING TOPACTIVE MOIETYCT03BSA18USAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
SULFURACTIVE MOIETY70FD1KFU70SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
BLACK CARROT ANTHOCYANINSINACTIVE INGREDIENT971DA56IOLSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
EUROPEAN ELDERBERRY JUICEINACTIVE INGREDIENTZ4IFJ0AK1ESAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52053-0001SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]10Current NDC, Legacy NDC, 2 package rows20241105_4dc2088f-3f13-4e49-83e4-44c2a26d195f.zip
52053-0001SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]2Current NDC, Legacy NDC, 2 package rows20220413_ce66e57d-ae46-0973-e053-2a95a90a6165.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sambucol Cold and Flu ReliefBRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUMPharmaCare US, Inc.4dc2088f-3f13-4e49-83e4-44c2a26d195f2024-11-04WarningsExact identifier
ndc (package): 52053-0001-2
ndc (product): 52053-0001
ndc11 (package): 52053000102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52053-0001-2520530001022 BLISTER PACK in 1 CARTON (52053-0001-2) / 4500 mg in 1 BLISTER PACK (52053-0001-1) 2 blister pack2017-06-300000-00-00NoNoCurrent