FDA.reportPublic FDA data

Genexa Kids Sleepology

Product NDC
69676-0053
11-digit product format
696760053
Labeler code
69676
Product ID
69676-0053_2f12abe7-5bb3-fa8e-e063-6394a90a6f47
Type
HUMAN OTC DRUG
Nonproprietary name
Alfalfa, Calcarea phosphorica, Chamomilla, Eschscholtzia californica, Melissa officinalis, Passiflora incarnata, Pulsatilla, Scutellaria lateriflora, Valeriana officinalis
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Genexa Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-01-28
Substance
ALFALFA; ESCHSCHOLZIA CALIFORNICA; MATRICARIA CHAMOMILLA WHOLE; MELISSA OFFICINALIS LEAF; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA TOP; TRIBASIC CALCIUM PHOSPHATE; VALERIAN
Active strength
6; 6; 6; 3; 6; 12; 3; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALFALFA6 [hp_X]/1
ESCHSCHOLZIA CALIFORNICA6 [hp_X]/1
MATRICARIA CHAMOMILLA WHOLE6 [hp_X]/1
MELISSA OFFICINALIS LEAF3 [hp_X]/1
PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]/1
PULSATILLA VULGARIS12 [hp_X]/1
SCUTELLARIA LATERIFLORA TOP3 [hp_X]/1
TRIBASIC CALCIUM PHOSPHATE8 [hp_X]/1
VALERIAN6 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDJO934BRBD, 9315HN272X, G0R4UBI2ZZ, 50D2ZE9219, CLF5YFS11O, I76KB35JEV, C6CNB75R61, 91D9GV0Z28, JWF5YAW3QW

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0053-12025-12-30C16284748780-12cef2736-7453-d83d-e063-dadaa90ab31fKIDS' SLEEPOLOGY
69676-0053-12025-01-30C16284748780-12cef2736-7453-d83d-e063-dadaa90ab31fKIDS' SLEEPOLOGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0053-1Genexa Kids Sleepology1 in 1 CARTONTABLET, CHEWABLE14
69676-0053-1Genexa Kids Sleepology60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0053GENEXA KIDS SLEEPOLOGY (ALFALFA, CALCAREA PHOSPHORICA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PULSATILLA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS) TABLET, CHEWABLE [GENEXA INC.]3Current NDC, Legacy NDC, 2 package rows20230121_ba0cd3c2-9883-9664-e053-2995a90a9fd4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69676-0053-1696760053011 BOTTLE, PLASTIC in 1 CARTON (69676-0053-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2021-01-280000-00-00NoNoCurrent