FDA.reportPublic FDA data

Sambucus Cold Flu Relief Elderberry

Product NDC
53499-5175
11-digit product format
534995175
Labeler code
53499
Product ID
53499-5175_fefba925-a094-463f-9b76-b460200f0a07
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium Sidoides Root, Aconitum Napellus, Eucalyptus Globulus Leaf, Sambucus Nigra Flowering Top, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Phosphorus, Ipecac
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-12-11
Substance
ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP
Active strength
4; 4; 2; 6; 4; 3; 1; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sambucus Cold Flu Relief Elderberry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/1
ACONITUM NAPELLUS4 [hp_X]/1
BRYONIA ALBA ROOT4 [hp_X]/1
EUCALYPTUS GLOBULUS LEAF2 [hp_X]/1
SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]/1
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/1
GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]/1
IPECAC3 [hp_X]/1
PHOSPHORUS6 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H6J53HEX8EInternal UNII lookup
U0NQ8555JDInternal UNII lookup
T7J046YI2BInternal UNII lookup
S546YLW6E6Internal UNII lookup
CT03BSA18UInternal UNII lookup
1W0775VX6EInternal UNII lookup
639KR60Q1QInternal UNII lookup
62I3C8233LInternal UNII lookup
27YLU75U4WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aaa28ba9-6abd-46da-8ffa-83178505aeeeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-5175-0Sambucus Cold Flu Relief Elderberry10 in 1 BLISTER PACKTABLET, CHEWABLE102
53499-5175-0Sambucus Cold Flu Relief Elderberry2 in 1 CARTONTABLET, CHEWABLE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-5175SAMBUCUS COLD FLU RELIEF ELDERBERRY (PELARGONIUM SIDOIDES ROOT, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA FLOWERING TOP, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECAC) TABLET, CHEWABLE [SCHWABE NORTH AMERICA, INC.]1Current NDC, 2 package rows20241212_aaa28ba9-6abd-46da-8ffa-83178505aeee.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
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
ndc (product): 53499-5175

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-5175-0534995175002 BLISTER PACK in 1 CARTON (53499-5175-0) / 10 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2024-12-11NoNoCurrent