FDA.reportPublic FDA data

Cold Flu Relief Berry

Product NDC
53499-0349
Requested package NDC
53499-0349-0
11-digit product format
534990349
Labeler code
53499
Product ID
53499-0349_399cfe53-cff6-41fb-8588-4f388b0bbcf6
Type
HUMAN OTC DRUG
Nonproprietary name
Cold Flu Relief Berry
Dosage form
POWDER
Route
ORAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-06-21
Substance
PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; IPECAC
Active strength
1; 4; 2; 4; 6; 4; 6; 3 [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg
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 Berry
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/912mg
ACONITUM NAPELLUS4 [hp_X]/912mg
EUCALYPTUS GLOBULUS LEAF2 [hp_X]/912mg
BRYONIA ALBA ROOT4 [hp_X]/912mg
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/912mg
GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]/912mg
PHOSPHORUS6 [hp_X]/912mg
IPECAC3 [hp_X]/912mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-0349-0Cold Flu Relief Berry912 mg in 1 PACKETPOWDER9124
53499-0349-0Cold Flu Relief Berry10 in 1 CARTONPOWDER104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-0349COLD FLU RELIEF BERRY POWDER [SCHWABE NORTH AMERICA, INC]3Current NDC, 2 package rows20250504_13e5c2a9-747d-4c01-89bd-47b6e8d453f7.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 BerryCOLD FLU RELIEF BERRYSchwabe North America, Inc13e5c2a9-747d-4c01-89bd-47b6e8d453f72025-07-31WarningsExact identifier
ndc (package): 53499-0349-0
ndc (product): 53499-0349
ndc11 (package): 53499034900

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-0349-05349903490010 PACKET in 1 CARTON (53499-0349-0) / 912 mg in 1 PACKET10 packet2024-06-21NoNoCurrent