sleepease

Generic: aquilegia, avena, chamomilla, coffea cruda, cypripedium, humulus, kali phos, passiflora, valeriana, zinc met

Labeler: eight & company l.l.c
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name sleepease
Generic Name aquilegia, avena, chamomilla, coffea cruda, cypripedium, humulus, kali phos, passiflora, valeriana, zinc met
Labeler eight & company l.l.c
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

aquilegia vulgaris 4 [hp_X]/41mL, arabica coffee bean 200 [hp_C]/41mL, avena sativa flowering top 4 [hp_X]/41mL, cypripedium parviflorum var. pubescens root 4 [hp_X]/41mL, dibasic potassium phosphate 12 [hp_X]/41mL, hops 4 [hp_X]/41mL, matricaria chamomilla whole 4 [hp_X]/41mL, passiflora incarnata flowering top 4 [hp_X]/41mL, valerian 4 [hp_X]/41mL, zinc 12 [hp_X]/41mL

Manufacturer
Eight & Company L.L.C

Identifiers & Regulatory

Product NDC 61096-2001
Product ID 61096-2001_cc630075-d315-46fe-a50d-3fb7f0215eb4
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 2019-04-24

Pharmacologic Class

Established (EPC)
non-standardized food allergenic extract [epc] non-standardized plant allergenic extract [epc]
Chemical Structure
allergens [cs] dietary proteins [cs] plant proteins [cs] seed storage proteins [cs] food additives [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 610962001
Hyphenated Format 61096-2001

Supplemental Identifiers

UPC
0361096000115
UNII
8POZ61U1G2 3SW678MX72 MA9CQJ3F7F 21Y9GZ1LZA CI71S98N1Z 01G73H6H83 G0R4UBI2ZZ CLF5YFS11O JWF5YAW3QW J41CSQ7QDS
NUI
N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0516536 M0008672

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sleepease (source: ndc)
Generic Name aquilegia, avena, chamomilla, coffea cruda, cypripedium, humulus, kali phos, passiflora, valeriana, zinc met (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 [hp_X]/41mL
  • 200 [hp_C]/41mL
  • 12 [hp_X]/41mL
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (61096-2001-1) / 41 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

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

Ingredients (10)

aquilegia vulgaris (4 [hp_X]/41mL) arabica coffee bean (200 [hp_C]/41mL) avena sativa flowering top (4 [hp_X]/41mL) cypripedium parviflorum var. pubescens root (4 [hp_X]/41mL) dibasic potassium phosphate (12 [hp_X]/41mL) hops (4 [hp_X]/41mL) matricaria chamomilla whole (4 [hp_X]/41mL) passiflora incarnata flowering top (4 [hp_X]/41mL) valerian (4 [hp_X]/41mL) zinc (12 [hp_X]/41mL)

Linked Drug Pages (1)

SleepEase ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cc630075-d315-46fe-a50d-3fb7f0215eb4", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "M0516536", "M0008672"], "upc": ["0361096000115"], "unii": ["8POZ61U1G2", "3SW678MX72", "MA9CQJ3F7F", "21Y9GZ1LZA", "CI71S98N1Z", "01G73H6H83", "G0R4UBI2ZZ", "CLF5YFS11O", "JWF5YAW3QW", "J41CSQ7QDS"], "spl_set_id": ["9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6"], "pharm_class_cs": ["Allergens [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]", "Seed Storage Proteins [CS]", "Food Additives [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]"], "manufacturer_name": ["Eight & Company L.L.C"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (61096-2001-1)  / 41 mL in 1 BOTTLE, SPRAY", "package_ndc": "61096-2001-1", "marketing_start_date": "20190424"}], "brand_name": "SleepEase", "product_id": "61096-2001_cc630075-d315-46fe-a50d-3fb7f0215eb4", "dosage_form": "LIQUID", "pharm_class": ["Allergens [CS]", "Allergens [CS]", "Cell-mediated Immunity [PE]", "Cell-mediated Immunity [PE]", "Dietary Proteins [CS]", "Dietary Proteins [CS]", "Food Additives [CS]", "Increased Histamine Release [PE]", "Increased Histamine Release [PE]", "Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]", "Plant Proteins [CS]", "Plant Proteins [CS]", "Seed Storage Proteins [CS]"], "product_ndc": "61096-2001", "generic_name": "Aquilegia, Avena, Chamomilla, Coffea cruda, Cypripedium, Humulus, Kali phos, Passiflora, Valeriana, Zinc met", "labeler_name": "Eight & Company L.L.C", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SleepEase", "active_ingredients": [{"name": "AQUILEGIA VULGARIS", "strength": "4 [hp_X]/41mL"}, {"name": "ARABICA COFFEE BEAN", "strength": "200 [hp_C]/41mL"}, {"name": "AVENA SATIVA FLOWERING TOP", "strength": "4 [hp_X]/41mL"}, {"name": "CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT", "strength": "4 [hp_X]/41mL"}, {"name": "DIBASIC POTASSIUM PHOSPHATE", "strength": "12 [hp_X]/41mL"}, {"name": "HOPS", "strength": "4 [hp_X]/41mL"}, {"name": "MATRICARIA CHAMOMILLA WHOLE", "strength": "4 [hp_X]/41mL"}, {"name": "PASSIFLORA INCARNATA FLOWERING TOP", "strength": "4 [hp_X]/41mL"}, {"name": "VALERIAN", "strength": "4 [hp_X]/41mL"}, {"name": "ZINC", "strength": "12 [hp_X]/41mL"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "20190424", "listing_expiration_date": "20261231"}