FDA.reportPublic FDA data

VITAL

Product NDC
50845-0257
11-digit product format
508450257
Labeler code
50845
Product ID
50845-0257_5976d173-abc7-4418-a6e5-4bc19937b657
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Montana, Carduus Marianus, Damiana, Galium Aparine, Hamamelis Virginiana, Hepar Suis, Hypophysis Suis, Panax Ginseng, L-Arginine, Oleum Animale, Schisandra Chinensis, Taraxacum Officinale, Thuja Occidentalis
Dosage form
SPRAY
Route
ORAL
Labeler
Liddell Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-26
Substance
ARGININE; ARNICA MONTANA WHOLE; ASIAN GINSENG; CERVUS ELAPHUS HORN OIL; GALIUM APARINE WHOLE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MILK THISTLE; PORK LIVER; SCHISANDRA CHINENSIS FRUIT; SUS SCROFA PITUITARY GLAND; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG
Active strength
6; 3; 3; 15; 3; 3; 3; 6; 3; 30; 3; 200; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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
VITAL
Brand name suffix
II
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARGININE6 [hp_X]/mL
ARNICA MONTANA WHOLE3 [hp_X]/mL
ASIAN GINSENG3 [hp_X]/mL
CERVUS ELAPHUS HORN OIL15 [hp_X]/mL
GALIUM APARINE WHOLE3 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK3 [hp_X]/mL
MILK THISTLE3 [hp_X]/mL
PORK LIVER6 [hp_X]/mL
SCHISANDRA CHINENSIS FRUIT3 [hp_X]/mL
SUS SCROFA PITUITARY GLAND30 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG200 [hp_C]/mL
TURNERA DIFFUSA LEAFY TWIG3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii94ZLA3W45F, O80TY208ZW, CUQ3A77YXI, 7A7G0PQI12, Z4B6561488, T7S323PKJS, U946SH95EE, 6EC706HI7F, ABS794681C, L0PFEMQ1DT, 39981FM375, 1NT28V9397, RQ2CFA7WWJ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0257-22024-07-01C16284748780-1ba0f9c33-1314-a910-e053-dadaa90a0b85DRUG FACTS:
50845-0257-22024-01-30C16284748780-1ba0f9c33-1314-a910-e053-dadaa90a0b85DRUG FACTS:
50845-0257-22022-04-20C16284748780-1ba0f9c33-1314-a910-e053-dadaa90a0b85DRUG FACTS:
50845-0257-22021-01-29C16284748780-1ba0f9c33-1314-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0257-1VITALII30 mL in 1 BOTTLE, SPRAYSPRAY303
50845-0257-2VITALII1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0257VITAL II (ARNICA MONTANA, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HYPOPHYSIS SUIS, PANAX GINSENG, L-ARGININE, OLEUM ANIMALE, SCHISANDRA CHINENSIS, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS) SPRAY [LIDDELL LABORATORIES, INC.]3Current NDC, Legacy NDC, 2 package rows20240702_04cded9a-0431-4e87-9055-ec4f38112559.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50845-0257-15084502570130 mL in 1 BOTTLE, SPRAY30 mlHistorical
50845-0257-2508450257021 BOTTLE, SPRAY in 1 CARTON (50845-0257-2) / 30 mL in 1 BOTTLE, SPRAY (50845-0257-1) 2019-06-260000-00-00NoNoCurrent