FDA.reportPublic FDA data

Sambucol Cold and Flu Relief

Product NDC
52053-0004
11-digit product format
520530004
Labeler code
52053
Product ID
52053-0004_fc0aa1b5-3fea-406c-b8e3-151531f1c0b8
Type
HUMAN OTC DRUG
Nonproprietary name
Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum
Dosage form
TABLET
Route
ORAL
Labeler
PharmaCare US, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-10-04
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

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
7dace656-ee97-4931-869f-8c8022757abbAvailable 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

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 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.7dace656-ee97-4931-869f-8c8022757abb2024-05-24WarningsExact identifier
ndc (product): 52053-0004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52053-0004-1520530004014 BLISTER PACK in 1 CARTON (52053-0004-1) / 4500 mg in 1 BLISTER PACK (52053-0004-2) 4 blister pack2021-10-040000-00-00NoNoCurrent
52053-0004-2520530004024500 mg in 1 BLISTER PACK4500 mgHistorical