Home NDC 53499-1513 Sambucus Cold Flu Relief Elderberry
Product NDC 53499-1513
11-digit product format 534991513
Labeler code 53499
Product ID 53499-1513_099c2af7-7ae5-4784-961a-df79fd185f74
Type HUMAN OTC DRUG
Nonproprietary name Sambucus Cold Flu Relief Elderberry
Dosage form SYRUP
Route ORAL
Labeler Schwabe North America
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2024-11-20
Substance PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; SAMBUCUS NIGRA FLOWERING TOP; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS
Active strength 1; 4; 2; 3; 4; 6; 4; 3; 6 [hp_X]/120mL; [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 2027-12-31
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 Cold Flu Relief Elderberry
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PELARGONIUM SIDOIDES ROOT 1 [hp_X]/120mL ACONITUM NAPELLUS 4 [hp_X]/120mL EUCALYPTUS GLOBULUS LEAF 2 [hp_X]/120mL SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X]/120mL BRYONIA ALBA ROOT 4 [hp_X]/120mL EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X]/120mL GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X]/120mL IPECAC 3 [hp_X]/120mL PHOSPHORUS 6 [hp_X]/120mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 9 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53499-1513-4 Sambucus Cold Flu Relief Elderberry 1 in 1 BOX SYRUP 1 3 53499-1513-4 Sambucus Cold Flu Relief Elderberry 120 mL in 1 BOTTLE SYRUP 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53499-1513 SAMBUCUS COLD FLU RELIEF ELDERBERRY SYRUP [SCHWABE NORTH AMERICA] 1 Current NDC, 2 package rows 20241122_dbcb3c3f-10a2-4e48-9fd9-bd6590c7239d.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53499-1513-4 53499151304 1 BOTTLE in 1 BOX (53499-1513-4) / 120 mL in 1 BOTTLE 1 bottle 2024-11-20 No No Current