serene sleep

Generic: eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla (pratensis), ignatia amara, kali phosphoricum, rhus tox

Labeler: the wellness center for research a
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name serene sleep
Generic Name eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla (pratensis), ignatia amara, kali phosphoricum, rhus tox
Labeler the wellness center for research a
Dosage Form SPRAY
Routes
ORAL
Active Ingredients

arabica coffee bean 6 [hp_C]/mL, artemisia cina pre-flowering top 6 [hp_C]/mL, dibasic potassium phosphate 30 [hp_C]/mL, eschscholzia californica whole 3 [hp_C]/mL, matricaria chamomilla whole 3 [hp_C]/mL, passiflora incarnata flowering top 6 [hp_C]/mL, pulsatilla pratensis whole 6 [hp_C]/mL, strychnos ignatii seed 30 [hp_C]/mL, strychnos nux-vomica seed 6 [hp_C]/mL, toxicodendron pubescens leaf 30 [hp_C]/mL

Manufacturer
The Wellness Center for Research a

Identifiers & Regulatory

Product NDC 50181-0080
Product ID 50181-0080_5b0d0301-c85f-4047-960f-ac9c150d827c
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Marketing Start 2022-02-14
Marketing End 2027-03-22

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]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 501810080
Hyphenated Format 50181-0080

Supplemental Identifiers

UNII
3SW678MX72 28M1820ACT CI71S98N1Z 9315HN272X G0R4UBI2ZZ CLF5YFS11O 8E272251DI 1NM3M2487K 269XH13919 6IO182RP7A
NUI
N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0516536 N0000185001

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 serene sleep (source: ndc)
Generic Name eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla (pratensis), ignatia amara, kali phosphoricum, rhus tox (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 [hp_C]/mL
  • 30 [hp_C]/mL
  • 3 [hp_C]/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, SPRAY (50181-0080-1)
source: ndc

Packages (1)

50181-0080-1 30 mL in 1 BOTTLE, SPRAY (50181-0080-1)

Ingredients (10)

arabica coffee bean (6 [hp_C]/mL) artemisia cina pre-flowering top (6 [hp_C]/mL) dibasic potassium phosphate (30 [hp_C]/mL) eschscholzia californica whole (3 [hp_C]/mL) matricaria chamomilla whole (3 [hp_C]/mL) passiflora incarnata flowering top (6 [hp_C]/mL) pulsatilla pratensis whole (6 [hp_C]/mL) strychnos ignatii seed (30 [hp_C]/mL) strychnos nux-vomica seed (6 [hp_C]/mL) toxicodendron pubescens leaf (30 [hp_C]/mL)

Linked Drug Pages (1)

Serene Sleep ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5b0d0301-c85f-4047-960f-ac9c150d827c", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "M0516536", "N0000185001"], "unii": ["3SW678MX72", "28M1820ACT", "CI71S98N1Z", "9315HN272X", "G0R4UBI2ZZ", "CLF5YFS11O", "8E272251DI", "1NM3M2487K", "269XH13919", "6IO182RP7A"], "spl_set_id": ["2d5bbd0d-9b50-45ce-aa23-05bd05b54645"], "pharm_class_cs": ["Allergens [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]", "Seed Storage Proteins [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]"], "manufacturer_name": ["The Wellness Center for Research a"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, SPRAY (50181-0080-1)", "package_ndc": "50181-0080-1", "marketing_end_date": "20270322", "marketing_start_date": "20220214"}], "brand_name": "Serene Sleep", "product_id": "50181-0080_5b0d0301-c85f-4047-960f-ac9c150d827c", "dosage_form": "SPRAY", "pharm_class": ["Allergens [CS]", "Allergens [CS]", "Cell-mediated Immunity [PE]", "Cell-mediated Immunity [PE]", "Dietary Proteins [CS]", "Increased Histamine Release [PE]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "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]", "Seed Storage Proteins [CS]"], "product_ndc": "50181-0080", "generic_name": "Eschscholtzia Californica, Chamomilla, Cina, Coffea Cruda, Nux Vomica, Passiflora Incarnata, Pulsatilla (Pratensis), Ignatia Amara, Kali Phosphoricum, Rhus Tox", "labeler_name": "The Wellness Center for Research a", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Serene Sleep", "active_ingredients": [{"name": "ARABICA COFFEE BEAN", "strength": "6 [hp_C]/mL"}, {"name": "ARTEMISIA CINA PRE-FLOWERING TOP", "strength": "6 [hp_C]/mL"}, {"name": "DIBASIC POTASSIUM PHOSPHATE", "strength": "30 [hp_C]/mL"}, {"name": "ESCHSCHOLZIA CALIFORNICA WHOLE", "strength": "3 [hp_C]/mL"}, {"name": "MATRICARIA CHAMOMILLA WHOLE", "strength": "3 [hp_C]/mL"}, {"name": "PASSIFLORA INCARNATA FLOWERING TOP", "strength": "6 [hp_C]/mL"}, {"name": "PULSATILLA PRATENSIS WHOLE", "strength": "6 [hp_C]/mL"}, {"name": "STRYCHNOS IGNATII SEED", "strength": "30 [hp_C]/mL"}, {"name": "STRYCHNOS NUX-VOMICA SEED", "strength": "6 [hp_C]/mL"}, {"name": "TOXICODENDRON PUBESCENS LEAF", "strength": "30 [hp_C]/mL"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_end_date": "20270322", "marketing_start_date": "20220214"}