Genexa Kids Calm Keeper

Product NDC
69676-0054
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

Additional Listing Data#

Finished product
Yes
Brand name base
Genexa Kids Calm Keeper
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS12 [hp_X]/1
GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]/1
MATRICARIA CHAMOMILLA WHOLE6 [hp_X]/1
PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]/1
POTASSIUM CARBONATE8 [hp_X]/1
STRYCHNOS IGNATII SEED12 [hp_X]/1
TRIBASIC CALCIUM PHOSPHATE8 [hp_X]/1
VALERIAN3 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, 639KR60Q1Q, G0R4UBI2ZZ, CLF5YFS11O, BQN1B9B9HA, 1NM3M2487K, 91D9GV0Z28, JWF5YAW3QW

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0054-12025-11-25C16284748780-12cef2736-839c-d83d-e063-dadaa90ab31fKIDS' CALM KEEPER
69676-0054-12025-01-30C16284748780-12cef2736-839c-d83d-e063-dadaa90ab31fKIDS' CALM KEEPER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0054-1Genexa Kids Calm Keeper1 in 1 CARTONTABLET, CHEWABLE14
69676-0054-1Genexa Kids Calm Keeper60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0054GENEXA KIDS CALM KEEPER (ACONITUM NAPELLUS, CALCAREA PHOSPHORICA, CHAMOMILLA, GELSEMIUM SEPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) TABLET, CHEWABLE [GENEXA INC.]3Current NDC, Legacy NDC, 2 package rows20230121_ba5de524-dac6-8b54-e053-2995a90ac6ef.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69676-0054-1696760054011 BOTTLE, PLASTIC in 1 CARTON (69676-0054-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2021-02-010000-00-00NoNoCurrent