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
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]/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

Additional Listing Data#

Finished product
Yes
Brand name base
Sambucus Cold Flu Relief Elderberry
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS4 [hp_X]/120mL
BRYONIA ALBA ROOT4 [hp_X]/120mL
EUCALYPTUS GLOBULUS LEAF2 [hp_X]/120mL
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/120mL
GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]/120mL
IPECAC3 [hp_X]/120mL
PELARGONIUM SIDOIDES ROOT1 [hp_X]/120mL
PHOSPHORUS6 [hp_X]/120mL
SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]/120mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, T7J046YI2B, S546YLW6E6, 1W0775VX6E, 639KR60Q1Q, 62I3C8233L, H6J53HEX8E, 27YLU75U4W, CT03BSA18U

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1513-4Sambucus Cold Flu Relief Elderberry1 in 1 BOXSYRUP13
53499-1513-4Sambucus Cold Flu Relief Elderberry120 mL in 1 BOTTLESYRUP1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-1513SAMBUCUS COLD FLU RELIEF ELDERBERRY SYRUP [SCHWABE NORTH AMERICA]1Current NDC, 2 package rows20241122_dbcb3c3f-10a2-4e48-9fd9-bd6590c7239d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-1513-4534991513041 BOTTLE in 1 BOX (53499-1513-4) / 120 mL in 1 BOTTLE1 bottle2024-11-20NoNoCurrent