FDA.reportPublic FDA data

Sleepology

Product NDC
69676-0012
11-digit product format
696760012
Labeler code
69676
Product ID
69676-0012_31cc448e-4472-22fa-e063-6294a90a360f
Type
HUMAN OTC DRUG
Nonproprietary name
Alfalfa, Avena sativa, Chamomilla, Eschscholtzia californica, Gelsemium sempervirens, Nux moschata, Passiflora incarnata, Piper methysticum, Valeriana officinalis
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Genexa Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-03-21
Substance
ALFALFA; AVENA SATIVA FLOWERING TOP; ESCHSCHOLZIA CALIFORNICA; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA CHAMOMILLA WHOLE; NUTMEG; PASSIFLORA INCARNATA FLOWERING TOP; PIPER METHYSTICUM ROOT; VALERIAN
Active strength
6; 6; 6; 12; 6; 9; 6; 6; 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
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], 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
Sleepology
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALFALFA6 [hp_X]/1
AVENA SATIVA FLOWERING TOP6 [hp_X]/1
ESCHSCHOLZIA CALIFORNICA6 [hp_X]/1
GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]/1
MATRICARIA CHAMOMILLA WHOLE6 [hp_X]/1
NUTMEG9 [hp_X]/1
PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]/1
PIPER METHYSTICUM ROOT6 [hp_X]/1
VALERIAN6 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDJO934BRBD, MA9CQJ3F7F, 9315HN272X, 639KR60Q1Q, G0R4UBI2ZZ, AEE24M3MQ9, CLF5YFS11O, BOW48C81XP, 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
69676-0012-12025-02-26C16284748780-12cef2736-ab58-d83d-e063-dadaa90ab31fSLEEPOLOGY
69676-0012-32025-02-26C16284748780-12cef2736-ab58-d83d-e063-dadaa90ab31fSLEEPOLOGY
69676-0012-12025-01-30C16284748780-12cef2736-ab58-d83d-e063-dadaa90ab31fSLEEPOLOGY
69676-0012-32025-01-30C16284748780-12cef2736-ab58-d83d-e063-dadaa90ab31fSLEEPOLOGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0012-1Sleepology60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE6015
69676-0012-1Sleepology1 in 1 CARTONTABLET, CHEWABLE115
69676-0012-3Sleepology2 in 1 POUCHTABLET, CHEWABLE215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0012SLEEPOLOGY (ALFALFA, AVENA SATIVA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, GELSEMIUM SEMPERVIRENS, NUX MOSCHATA, PASSIFLORA INCARNATA, PIPER METHYSTICUM, VALERIANA OFFICINALIS) TABLET, CHEWABLE [GENEXA INC.]15Current NDC, Legacy NDC, 3 package rows20250406_1e11f655-374c-59ac-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69676-0012-1696760012011 BOTTLE, PLASTIC in 1 CARTON (69676-0012-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2016-03-210000-00-00NoNoCurrent
69676-0012-3696760012032 TABLET, CHEWABLE in 1 POUCH (69676-0012-3) 2017-10-300000-00-00YesNoCurrent