FDA.reportPublic FDA data

Cold Flu Relief Elderberry

Product NDC
53499-2845
11-digit product format
534992845
Labeler code
53499
Product ID
53499-2845_b1dac11c-acaf-4aec-9c13-b90cafe519c3
Type
HUMAN OTC DRUG
Nonproprietary name
Cold Flu Relief Elderberry
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-02-06
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
Cold Flu Relief Elderberry
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/120mL
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
IPECAC3 [hp_X]/120mL
PHOSPHORUS6 [hp_X]/120mL

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
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
27ec0362-b762-442e-ad82-1f17fe15858eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-2845-7Cold Flu Relief Elderberry120 mL in 1 BOTTLESYRUP1205
53499-2845-7Cold Flu Relief Elderberry1 in 1 BOXSYRUP15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-2845-7ML - Milliliter53499-28457e3fabeb-4a36-491d-bd2c-f92f9f5cea9412025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-2845COLD FLU RELIEF ELDERBERRY SYRUP [SCHWABE NORTH AMERICA]3Current NDC, 2 package rows20250309_27ec0362-b762-442e-ad82-1f17fe15858e.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
Cold Flu Relief ElderberryCOLD FLU RELIEF ELDERBERRYSchwabe North America27ec0362-b762-442e-ad82-1f17fe15858e2026-03-05WarningsExact identifier
ndc (product): 53499-2845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-2845-7534992845071 BOTTLE in 1 BOX (53499-2845-7) / 120 mL in 1 BOTTLE1 bottle2024-02-06NoNoCurrent