MedPath

PASSI VALERIAN

BM HOMEOPATHIC LIQUID PASSI VALERIAN

Approved
Approval ID

3b3ae7ec-48e8-49b4-e063-6394a90a9789

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, gelsemium, kali phos, moschus, passiflora, valeriana

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85816-6012
Product Classification
G
Generic Name
arnica montana, gelsemium, kali phos, moschus, passiflora, valeriana
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (7)

ARNICA MONTANAActive
Quantity: 4 [hp_X] in 1 mL
Code: O80TY208ZW
Classification: ACTIB
GELSEMIUM SEMPERVIRENS ROOTActive
Quantity: 4 [hp_C] in 1 mL
Code: 639KR60Q1Q
Classification: ACTIB
VALERIANActive
Quantity: 3 [hp_X] in 1 mL
Code: JWF5YAW3QW
Classification: ACTIB
ALCOHOLInactive
Quantity: 0.96 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
DIBASIC POTASSIUM PHOSPHATEActive
Quantity: 6 [hp_X] in 1 mL
Code: CI71S98N1Z
Classification: ACTIB
MOSCHUS MOSCHIFERUS MUSK SAC RESINActive
Quantity: 6 [hp_X] in 1 mL
Code: 8KFK4W7KP7
Classification: ACTIB
PASSIFLORA INCARNATA FLOWERING TOPActive
Quantity: 6 [hp_X] in 1 mL
Code: CLF5YFS11O
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Passi Valerian

INDICATIONS & USAGE SECTION

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

A traditional homoeopathic formula for the temporary relieve of sleep disturbances due to symptoms of mild anxiety, for detail please read the enclosed package.
(Product information leaflet).

CONTRAINDICATIONS SECTION

LOINC: 34070-3Updated: 1/1/2015

Care & contra-indications:
This is a homoeopathic remedy, no contra-indications are established.

DOSAGE & ADMINISTRATION SECTION

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

25-30 drops in half cup of water an hour before going to bed

OTC - ACTIVE INGREDIENT SECTION

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

arnica montana, gelsemium, kali phos, moschus, passiflora, valeriana

INACTIVE INGREDIENT SECTION

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

ALCOHOL

OTC - PURPOSE SECTION

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

A traditional homoeopathic formula for the temporary relieve of sleep disturbances due to symptoms of mild anxiety, for detail please read the enclosed package.
(Product information leaflet).

WARNINGS SECTION

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

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

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.

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