FDA.reportPublic FDA data

PASSI VALERIAN

Product NDC
85816-6012
11-digit product format
858166012
Labeler code
85816
Product ID
85816-6012_3b3ae7ec-48e9-49b4-e063-6394a90a9789
Type
HUMAN OTC DRUG
Nonproprietary name
arnica montana, gelsemium, kali phos, moschus, passiflora, valeriana
Dosage form
LIQUID
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
ARNICA MONTANA; DIBASIC POTASSIUM PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN
Active strength
4; 6; 4; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PASSI VALERIAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA4 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]/mL
VALERIAN4 [hp_C]/mL
DIBASIC POTASSIUM PHOSPHATE6 [hp_X]/mL
MOSCHUS MOSCHIFERUS MUSK SAC RESIN6 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O80TY208ZWInternal UNII lookup
639KR60Q1QInternal UNII lookup
JWF5YAW3QWInternal UNII lookup
CI71S98N1ZInternal UNII lookup
8KFK4W7KP7Internal UNII lookup
CLF5YFS11OInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b3ae7ec-48e8-49b4-e063-6394a90a9789Available on FDA.report

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

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 (product): 85816-6012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-6012-18581660120130 mL in 1 BOTTLE, GLASS (85816-6012-1) 30 ml2015-01-01NoNoCurrent