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Carpellum Mali Comp.

Carpellum Mali Comp.

Approved
Approval ID

d6097ade-ed9c-4903-b0ea-c9424909d657

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

Uriel Pharmacy Inc.

DUNS: 043471163

Products 1

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

Carpellum Mali Comp.

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code48951-3034
Product Classification
G
Generic Name
Carpellum Mali Comp.
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (4)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
MALUS DOMESTICA WHOLEActive
Quantity: 4 [hp_X] in 1 mL
Code: 04W636S1V3
Classification: ACTIB
ENGLISH WALNUTActive
Quantity: 4 [hp_X] in 1 mL
Code: 1V3SHR7QB7
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

Carpellum Mali comp. Liquid

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/13/2014

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/13/2014

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/13/2014

Active Ingredients: Juglans regia (Walnut) 4X, Pyrus malus (Lining of apple seed chamber) 4X

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/13/2014

Inactive Ingredients: Distilled water, Organic cane alcohol

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/13/2014

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/13/2014

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/13/2014

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/13/2014

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
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Carpellum Mali Comp. - FDA Drug Approval Details