MedPath

Cold Flu Relief Berry

Cold Flu Relief FastActives Berry Packets

Approved
Approval ID

13e5c2a9-747d-4c01-89bd-47b6e8d453f7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

Schwabe North America, Inc

DUNS: 831153908

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cold Flu Relief Berry

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53499-0349
Product Classification
G
Generic Name
Cold Flu Relief Berry
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (14)

PELARGONIUM SIDOIDES ROOTActive
Quantity: 1 [hp_X] in 912 mg
Code: H6J53HEX8E
Classification: ACTIB
ACONITUM NAPELLUSActive
Quantity: 4 [hp_X] in 912 mg
Code: U0NQ8555JD
Classification: ACTIB
EUCALYPTUS GLOBULUS LEAFActive
Quantity: 2 [hp_X] in 912 mg
Code: S546YLW6E6
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 4 [hp_X] in 912 mg
Code: T7J046YI2B
Classification: ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOPActive
Quantity: 6 [hp_X] in 912 mg
Code: 1W0775VX6E
Classification: ACTIB
PHOSPHORUSActive
Quantity: 6 [hp_X] in 912 mg
Code: 27YLU75U4W
Classification: ACTIB
IPECACActive
Quantity: 3 [hp_X] in 912 mg
Code: 62I3C8233L
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
GELSEMIUM SEMPERVIRENS ROOTActive
Quantity: 4 [hp_X] in 912 mg
Code: 639KR60Q1Q
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/31/2025

LHBN15349_B02_Umcka_Cold+Flu_BerryFA_CTN_FNL.jpg

LHPK15349_B02_Umcka_Cold+Flu_BerryFA_PKT_FNL.jpg

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Cold Flu Relief Berry - FDA Drug Approval Details