Home NDC 69676-0053 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 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69676-0053-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69676-0053-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69676-0053-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69676-0053-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69676-0053-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69676-0053-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69676-0053-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69676-0053-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69676-0053-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Genexa Kids Sleepology
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESCHSCHOLZIA CALIFORNICA 6 [hp_X]/1 PASSIFLORA INCARNATA FLOWERING TOP 6 [hp_X]/1 VALERIAN 6 [hp_X]/1 MATRICARIA CHAMOMILLA WHOLE 3 [hp_X]/1 TRIBASIC CALCIUM PHOSPHATE 6 [hp_X]/1 SCUTELLARIA LATERIFLORA TOP 12 [hp_X]/1 MELISSA OFFICINALIS LEAF 3 [hp_X]/1 PULSATILLA VULGARIS 8 [hp_X]/1 ALFALFA 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 69676-0053-1 Genexa Kids Sleepology 1 in 1 CARTON TABLET, CHEWABLE 1 4 69676-0053-1 Genexa Kids Sleepology 60 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69676-0053 GENEXA KIDS SLEEPOLOGY (ALFALFA, CALCAREA PHOSPHORICA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PULSATILLA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS) TABLET, CHEWABLE [GENEXA INC.] 3 Current NDC, Legacy NDC, 2 package rows 20230121_ba0cd3c2-9883-9664-e053-2995a90a9fd4.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 Genexa Kids Sleepology ALFALFA, CALCAREA PHOSPHORICA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PULSATILLA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS Genexa Inc. ba0cd3c2-9883-9664-e053-2995a90a9fd4 2025-02-26 Warnings Exact identifier ndc (product): 69676-0053
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69676-0053-1 69676005301 1 BOTTLE, PLASTIC in 1 CARTON (69676-0053-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC 2021-01-28 0000-00-00 No No Current