FDA.reportPublic FDA data

Sambucus Flu Relief

Product NDC
53499-0803
11-digit product format
534990803
Labeler code
53499
Product ID
53499-0803_e952da08-d4e8-46a8-8330-99accec78283
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOP
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-11-30
Substance
ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; SAMBUCUS NIGRA FLOWERING TOP; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; IPECAC
Active strength
4; 2; 3; 4; 6; 4; 6; 3 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL
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
Sambucus Flu Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS4 [hp_X]/120mL
EUCALYPTUS GLOBULUS LEAF2 [hp_X]/120mL
SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]/120mL
BRYONIA ALBA ROOT4 [hp_X]/120mL
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/120mL
GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]/120mL
PHOSPHORUS6 [hp_X]/120mL
IPECAC3 [hp_X]/120mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
ca7d57b0-ffae-415f-a959-b0c88ae7dd40Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-0803-5Sambucus Flu Relief1 in 1 BOXSYRUP14
53499-0803-5Sambucus Flu Relief120 mL in 1 BOTTLE, PLASTICSYRUP1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-0803SAMBUCUS FLU RELIEF (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOP ) SYRUP [SCHWABE NORTH AMERICA, INC.]3Current NDC, 2 package rows20240404_ca7d57b0-ffae-415f-a959-b0c88ae7dd40.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 Flu ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOPSchwabe North America, Inc.ca7d57b0-ffae-415f-a959-b0c88ae7dd402025-12-08WarningsExact identifier
ndc (product): 53499-0803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53499-0803-5534990803051 BOTTLE, PLASTIC in 1 BOX (53499-0803-5) / 120 mL in 1 BOTTLE, PLASTIC2023-11-30NoNoCurrent