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
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
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 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

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