Sleepology for Children

Product NDC
69676-0018
Requested package NDC
69676-0018-1
11-digit product format
696760018
Labeler code
69676
Product ID
69676-0018_ba0d81fe-1e6a-2c64-e053-2995a90a219b
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
2018-02-12
Marketing end
2023-08-31
Substance
ALFALFA; ESCHSCHOLZIA CALIFORNICA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; MATRICARIA CHAMOMILLA WHOLE; TRIBASIC CALCIUM PHOSPHATE; SCUTELLARIA LATERIFLORA TOP; MELISSA OFFICINALIS LEAF; PULSATILLA VULGARIS
Active strength
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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69676-001869676-0018-1DDiscontinued by firm2026-10-05

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69676-0018-1696760018011 BOTTLE, PLASTIC in 1 CARTON (69676-0018-1) > 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2018-02-122023-08-31NoNoCurrent