Home NDC 69676-0012 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69676-0012-3 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69676-0012-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69676-0012-3 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69676-0012-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69676-0012-3 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69676-0012-1 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Sleepology
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVENA SATIVA FLOWERING TOP 6 [hp_X]/1 ALFALFA 6 [hp_X]/1 ESCHSCHOLZIA CALIFORNICA 6 [hp_X]/1 PASSIFLORA INCARNATA FLOWERING TOP 12 [hp_X]/1 NUTMEG 6 [hp_X]/1 VALERIAN 9 [hp_X]/1 PIPER METHYSTICUM ROOT 6 [hp_X]/1 GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]/1 MATRICARIA CHAMOMILLA WHOLE 6 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 9 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69676-0012-1 Sleepology 60 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 60 15 69676-0012-1 Sleepology 1 in 1 CARTON TABLET, CHEWABLE 1 15 69676-0012-3 Sleepology 2 in 1 POUCH TABLET, CHEWABLE 2 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69676-0012 SLEEPOLOGY (ALFALFA, AVENA SATIVA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, GELSEMIUM SEMPERVIRENS, NUX MOSCHATA, PASSIFLORA INCARNATA, PIPER METHYSTICUM, VALERIANA OFFICINALIS) TABLET, CHEWABLE [GENEXA INC.] 15 Current NDC, Legacy NDC, 3 package rows 20250406_1e11f655-374c-59ac-e054-00144ff8d46c.zip
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sleepology ALFALFA, AVENA SATIVA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, GELSEMIUM SEMPERVIRENS, NUX MOSCHATA, PASSIFLORA INCARNATA, PIPER METHYSTICUM, VALERIANA OFFICINALIS Genexa Inc. 1e11f655-374c-59ac-e054-00144ff8d46c 2025-04-02 Warnings Exact identifier ndc (product): 69676-0012
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69676-0012-1 69676001201 1 BOTTLE, PLASTIC in 1 CARTON (69676-0012-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC 2016-03-21 0000-00-00 No No Current 69676-0012-3 69676001203 2 TABLET, CHEWABLE in 1 POUCH (69676-0012-3) 2017-10-30 0000-00-00 Yes No Current