Home NDC 69676-0054-1 Genexa Kids Calm Keeper
Product NDC 69676-0054
Requested package NDC 69676-0054-1
11-digit product format 696760054
Labeler code 69676
Product ID 69676-0054_4471ce51-53e1-f3bd-e063-6294a90a4898
Type HUMAN OTC DRUG
Nonproprietary name Aconitum napellus, Calcarea phosphorica, Chamomilla, Gelsemium sepervirens, Ignatia amara, Kali carbonicum, Passiflora incarnata, Valeriana officinalis
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Genexa Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2021-02-01
Substance ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; STRYCHNOS IGNATII SEED; TRIBASIC CALCIUM PHOSPHATE; VALERIAN
Active strength 12; 12; 6; 3; 8; 12; 8; 3 [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 Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Genexa Kids Calm Keeper
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIBASIC CALCIUM PHOSPHATE 12 [hp_X]/1 MATRICARIA CHAMOMILLA WHOLE 12 [hp_X]/1 GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]/1 STRYCHNOS IGNATII SEED 3 [hp_X]/1 POTASSIUM CARBONATE 8 [hp_X]/1 VALERIAN 12 [hp_X]/1 PASSIFLORA INCARNATA FLOWERING TOP 8 [hp_X]/1 ACONITUM NAPELLUS 3 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 8 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 69676-0054-1 Genexa Kids Calm Keeper 1 in 1 CARTON TABLET, CHEWABLE 1 4 69676-0054-1 Genexa Kids Calm Keeper 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 69676-0054 GENEXA KIDS CALM KEEPER (ACONITUM NAPELLUS, CALCAREA PHOSPHORICA, CHAMOMILLA, GELSEMIUM SEPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) TABLET, CHEWABLE [GENEXA INC.] 3 Current NDC, Legacy NDC, 2 package rows 20230121_ba5de524-dac6-8b54-e053-2995a90ac6ef.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69676-0054-1 69676005401 1 BOTTLE, PLASTIC in 1 CARTON (69676-0054-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC 2021-02-01 0000-00-00 No No Current