Sambucus Cold Flu Relief Elderberry

Product NDC
53499-5182
11-digit product format
534995182
Labeler code
53499
Product ID
53499-5182_f3b49948-0447-47f4-a07c-712c2e0c730c
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
POWDER
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-01-10
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]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g
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]/5.3g
ACONITUM NAPELLUS4 [hp_X]/5.3g
EUCALYPTUS GLOBULUS LEAF2 [hp_X]/5.3g
SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]/5.3g
BRYONIA ALBA ROOT4 [hp_X]/5.3g
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/5.3g
GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]/5.3g
PHOSPHORUS6 [hp_X]/5.3g
IPECAC3 [hp_X]/5.3g

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
S546YLW6E6Internal UNII lookup
CT03BSA18UInternal UNII lookup
T7J046YI2BInternal UNII lookup
1W0775VX6EInternal UNII lookup
639KR60Q1QInternal UNII lookup
27YLU75U4WInternal UNII lookup
62I3C8233LInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5de8a3db-6103-4b69-8e47-c78bc7c6bfcdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-5182-0Sambucus Cold Flu Relief Elderberry5.3 g in 1 PACKETPOWDER5.31
53499-5182-0Sambucus Cold Flu Relief Elderberry10 in 1 CARTONPOWDER101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-5182SAMBUCUS 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) POWDER [SCHWABE NORTH AMERICA, INC.]1Current NDC, 2 package rows20250112_5de8a3db-6103-4b69-8e47-c78bc7c6bfcd.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.5de8a3db-6103-4b69-8e47-c78bc7c6bfcd2025-01-10WarningsExact identifier
ndc (product): 53499-5182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-5182-05349951820010 PACKET in 1 CARTON (53499-5182-0) / 5.3 g in 1 PACKET10 packet2025-01-10NoNoCurrent