FDA.reportPublic FDA data

PASSI VALERIAN

Manufacturer
BM Private Limited
Effective date
2025-07-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:34:35

Label at a glance#

ProductPASSI VALERIAN
Active ingredientARNICA MONTANA, GELSEMIUM SEMPERVIRENS ROOT, VALERIAN, DIBASIC POTASSIUM PHOSPHATE, MOSCHUS MOSCHIFERUS MUSK SAC RESIN, PASSIFLORA INCARNATA FLOWERING TOP
Label structure9 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

ALCOHOL

INDICATIONS & USAGE SECTION

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).

OTC - PURPOSE SECTION

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

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

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Passi ValerianPassi Valerian

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-6012-1PASSI VALERIAN30 mL in 1 BOTTLE, GLASSLIQUID301

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85816-601285816-6012-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
VALERIANJWF5YAW3QWACTIB
ALCOHOL3K9958V90MIACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
MOSCHUS MOSCHIFERUS MUSK SAC RESIN8KFK4W7KP7ACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB

Source Document#

Source XML

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
PASSI VALERIANARNICA MONTANA, GELSEMIUM, KALI PHOS, MOSCHUS, PASSIFLORA, VALERIANABM Private Limited3b3ae7ec-48e8-49b4-e063-6394a90a97892025-07-31WarningsExact identifier
ndc (package): 85816-6012-1
ndc (product): 85816-6012
ndc11 (package): 85816601201
spl id: 3b3ae7ec-48e9-49b4-e063-6394a90a9789
spl set id: 3b3ae7ec-48e8-49b4-e063-6394a90a9789

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.