FDA.reportPublic FDA data

Genexa Stress

Product NDC
69676-0048
11-digit product format
696760048
Labeler code
69676
Product ID
69676-0048_31cbff6a-30bd-df7a-e063-6394a90aee99
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum napellus, Calcarea carbonica, Gelsemium sempervirens, Lycopodium clavatum, Nux vomica, Passiflora incarnata, Valeriana officinalis
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Genexa Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-01-07
Substance
ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; VALERIAN
Active strength
12; 12; 12; 8; 3; 12; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Genexa Stress
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS12 [hp_X]/1
GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]/1
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/1
OYSTER SHELL CALCIUM CARBONATE, CRUDE8 [hp_X]/1
PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]/1
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/1
VALERIAN3 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, 639KR60Q1Q, C88X29Y479, 2E32821G6I, CLF5YFS11O, 269XH13919, JWF5YAW3QW

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0048-12025-02-26C16284748780-12cef2736-72b3-d83d-e063-dadaa90ab31fSTRESS
69676-0048-32025-02-26C16284748780-12cef2736-72b3-d83d-e063-dadaa90ab31fSTRESS
69676-0048-12025-01-30C16284748780-12cef2736-72b3-d83d-e063-dadaa90ab31fSTRESS
69676-0048-32025-01-30C16284748780-12cef2736-72b3-d83d-e063-dadaa90ab31fSTRESS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0048-1Genexa Stress1 in 1 CARTONTABLET, CHEWABLE16
69676-0048-1Genexa Stress60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE606
69676-0048-3Genexa Stress2 in 1 POUCHTABLET, CHEWABLE26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0048GENEXA STRESS (ACONITUM NAPELLUS, CALCAREA CARBONICA, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NUX VOMICA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) TABLET, CHEWABLE [GENEXA INC.]6Current NDC, Legacy NDC, 3 package rows20250406_b86a2e37-fbc0-7c31-e053-2a95a90ad5d0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69676-0048-1696760048011 BOTTLE, PLASTIC in 1 CARTON (69676-0048-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2021-01-070000-00-00NoNoCurrent
69676-0048-3696760048032 TABLET, CHEWABLE in 1 POUCH (69676-0048-3) 2022-12-080000-00-00YesNoCurrent