NDC 61096-2001

SleepEase

Aquilegia, Avena, Chamomilla, Coffea Cruda, Cypripedium, Humulus, Kali Phos, Passiflora, Valeriana, Zinc Met

SleepEase is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Eight & Company L.l.c. The primary component is Aquilegia Vulgaris; Avena Sativa Flowering Top; Matricaria Recutita; Arabica Coffee Bean; Cypripedium Parviflorum Var. Pubescens Root; Hops; Potassium Phosphate, Dibasic; Passiflora Incarnata Flowering Top; Valerian; Zinc.

• Product ID: 61096-2001_a44e8268-1df3-495f-984a-b4c3b95f259d
• NDC: 61096-2001
• Product Type: Human Prescription Drug
• Proprietary Name: SleepEase
• Generic Name: Aquilegia, Avena, Chamomilla, Coffea Cruda, Cypripedium, Humulus, Kali Phos, Passiflora, Valeriana, Zinc Met
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-24
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: Eight & Company L.L.C
• Substance Name: AQUILEGIA VULGARIS; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; HOPS; POTASSIUM PHOSPHATE, DIBASIC; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; ZINC
• Active Ingredient Strength: 4 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL
• Pharm Classes: Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61096-2001-1

1 BOTTLE, SPRAY in 1 CARTON (61096-2001-1) > 41 mL in 1 BOTTLE, SPRAY

• Marketing Start Date: 2019-04-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61096-2001-1 [61096200101]

SleepEase LIQUID

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-24

Drug Details

Active Ingredients

Ingredient	Strength
AQUILEGIA VULGARIS	4 [hp_X]/41mL

OpenFDA Data

• SPL SET ID: 9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6
• Manufacturer:
  • Eight & Company L.L.C
• UNII:
  • 21Y9GZ1LZA
  • JWF5YAW3QW
  • MA9CQJ3F7F
  • CLF5YFS11O
  • J41CSQ7QDS
  • CI71S98N1Z
  • G0R4UBI2ZZ
  • 01G73H6H83
  • 3SW678MX72
  • 8POZ61U1G2

Pharmacological Class

• Non-Standardized Food Allergenic Extract [EPC]
• Non-Standardized Plant Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]
• Dietary Proteins [CS]
• Plant Proteins [CS]
• Seed Storage Proteins [CS]
• Food Additives [CS]
• Non-Standardized Food Allergenic Extract [EPC]
• Non-Standardized Plant Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]
• Dietary Proteins [CS]
• Plant Proteins [CS]
• Seed Storage Proteins [CS]
• Non-Standardized Food Allergenic Extract [EPC]
• Non-Standardized Plant Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]
• Dietary Proteins [CS]
• Plant Proteins [CS]
• Food Additives [CS]