MedPath

KALMIA

HOMEOPATHIC LIQUID KALMIA/ BM224

Approved
Approval ID

3b3c955d-453e-28e2-e063-6394a90a6bf9

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

BM Private Limited

DUNS: 645599762

Products 1

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

arnica montana, chelidonium, colchicum, kalmia, ranunculus bulb, sanguinaria nit, sumbul

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85816-2224
Product Classification
G
Generic Name
arnica montana, chelidonium, colchicum, kalmia, ranunculus bulb, sanguinaria nit, sumbul
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (8)

FERULA SUMBUL ROOTActive
Quantity: 10 [hp_X] in 1 mL
Code: GLA4808EHQ
Classification: ACTIB
ALCOHOLInactive
Quantity: 0.96 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
RANUNCULUS BULBOSUS ROOTActive
Quantity: 10 [hp_X] in 1 mL
Code: XV11P9Y1A1
Classification: ACTIB
SANGUINARIA CANADENSIS ROOTActive
Quantity: 7 [hp_X] in 1 mL
Code: N9288CD508
Classification: ACTIB
COLCHICUM AUTUMNALE BULBActive
Quantity: 7 [hp_X] in 1 mL
Code: 993QHL78E6
Classification: ACTIB
CHELIDONIUM MAJUSActive
Quantity: 7 [hp_X] in 1 mL
Code: 7E889U5RNN
Classification: ACTIB
ARNICA MONTANAActive
Quantity: 6 [hp_X] in 1 mL
Code: O80TY208ZW
Classification: ACTIB
KALMIA LATIFOLIA LEAFActive
Quantity: 6 [hp_X] in 1 mL
Code: 79N6542N18
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2015

Kalmia.jpgEntire package

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2015

For detail, please read the enclosed package (product information leaflet)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2015

10-15 drops, 3-4 times a day in some water

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2015

arnica montana, chelidonium, colchicum, kalmia, ranunculus bulb, sanguinaria nit, sumbul

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2015

ALCOHOL

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2015

For detail, please read the enclosed package (product information leaflet)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2015

Precautions/storage:
Keep away from children and store at cool and dry place.

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2015

Precautions/storage:
Keep away from children and store at cool and dry place.

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KALMIA - FDA Drug Approval Details