NDC 69676-0008

Calm Keeper

Aconitum Napellus, Calcarea Phosphorica, Chamomilla, Gelsemium Sepervirens, Ignatia Amara, Kali Carbonicum, Passiflora Incarnata, Valeriana Officinalis

Calm Keeper is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Genexa Inc.. The primary component is Tribasic Calcium Phosphate; Matricaria Chamomilla Whole; Gelsemium Sempervirens Root; Strychnos Ignatii Seed; Potassium Carbonate; Valerian; Passiflora Incarnata Flowering Top; Aconitum Napellus.

• Product ID: 69676-0008_7900262d-90fe-6c08-e053-2991aa0a77f9
• NDC: 69676-0008
• Product Type: Human Otc Drug
• Proprietary Name: Calm Keeper
• Generic Name: Aconitum Napellus, Calcarea Phosphorica, Chamomilla, Gelsemium Sepervirens, Ignatia Amara, Kali Carbonicum, Passiflora Incarnata, Valeriana Officinalis
• Dosage Form: Tablet, Chewable
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-20
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: Genexa Inc.
• Substance Name: TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA WHOLE; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP; ACONITUM NAPELLUS
• Active Ingredient Strength: 8 [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: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69676-0008-1

1 BOTTLE, PLASTIC in 1 CARTON (69676-0008-1) > 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2018-07-20
• Marketing End Date: 2023-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69676-0008-1 [69676000801]

Calm Keeper TABLET, CHEWABLE

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-07-20

Drug Details

Active Ingredients

Ingredient	Strength
TRIBASIC CALCIUM PHOSPHATE	8 [hp_X]/1

OpenFDA Data

• SPL SET ID: 7900262d-90fd-6c08-e053-2991aa0a77f9
• Manufacturer:
  • Genexa Inc.
• UNII:
  • JWF5YAW3QW
  • CLF5YFS11O
  • 639KR60Q1Q
  • 91D9GV0Z28
  • BQN1B9B9HA
  • 1NM3M2487K
  • U0NQ8555JD

NDC Crossover Matching brand name "Calm Keeper" or generic name "Aconitum Napellus, Calcarea Phosphorica, Chamomilla, Gelsemium Sepervirens, Ignatia Amara, Kali Carbonicum, Passiflora Incarnata, Valeriana Officinalis"

NDC	Brand Name	Generic Name
69676-0008	Calm Keeper	Aconitum napellus, Calcarea phosphorica, Chamomilla, Gelsemium sepervirens, Ignatia amara, Kali carbonicum, Passiflora incarnata, Valeriana officinalis
69676-0027	Calm Keeper	Aconitum napellus, Calcarea phosphorica, Chamomilla, Gelsemium sepervirens, Ignatia amara, Kali carbonicum, Passiflora incarnata, Valeriana officinalis
69676-0054	Genexa Kids Calm Keeper	Aconitum napellus, Calcarea phosphorica, Chamomilla, Gelsemium sepervirens, Ignatia amara, Kali carbonicum, Passiflora incarnata, Valeriana officinalis