Search by Drug Name or NDC

NDC 50181-0080-01 Serene Sleep 6; 6; 30; 3; 3; 6; 6; 30; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Details

Serene Sleep 6; 6; 30; 3; 3; 6; 6; 30; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL

Serene Sleep is a ORAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by The Wellness Center for Research a. The primary component is ARABICA COFFEE BEAN; ARTEMISIA CINA PRE-FLOWERING TOP; DIBASIC POTASSIUM PHOSPHATE; ESCHSCHOLZIA CALIFORNICA WHOLE; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA PRATENSIS WHOLE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA S.

Product Information

NDC	50181-0080
Product ID	50181-0080_675393a5-8656-4e9d-a6f0-5c7b3186fb67
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Serene Sleep
Proprietary Name Suffix	n/a
Non-Proprietary Name	Eschscholtzia Californica, Chamomilla, Cina, Coffea Cruda, Nux Vomica, Passiflora Incarnata, Pulsatilla (Pratensis), Ignatia Amara, Kali Phosphoricum, Rhus Tox
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	ORAL
Active Ingredient Strength	6; 6; 30; 3; 3; 6; 6; 30; 6; 30
Active Ingredient Units	[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Substance Name	ARABICA COFFEE BEAN; ARTEMISIA CINA PRE-FLOWERING TOP; DIBASIC POTASSIUM PHOSPHATE; ESCHSCHOLZIA CALIFORNICA WHOLE; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA PRATENSIS WHOLE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA S
Labeler Name	The Wellness Center for Research a
Pharmaceutical 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 [E
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50181-0080-01 (50181008001)

Pricing Information	N/A
NDC Package Code	50181-0080-1
Billing NDC	50181008001
Package	30 mL in 1 BOTTLE, SPRAY (50181-0080-1)
Marketing Start Date	2022-02-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2d5bbd0d-9b50-45ce-aa23-05bd05b54645 Details

ACTIVE INGREDIENTS:

Eschscholtzia Californica 3C, Chamomilla 3C, 6C, 30C, Cina 6C, 30C, Coffea Cruda 6C, 30C, Nux Vomica 6C, 30C, Passiflora Incarnata 6C, 30C, Pulsatilla (Pratensis) 6C, 30C, Ignatia Amara 30C, Kali Phosphoricum 30C, Rhus Tox 30C.

INDICATIONS:

Supports a reduction in stress-related sleep issues, nightmares, waking during the early morning hours. Temporary relief of nervousness, anxiety, restlessness. overactive mind, mood disorders, grief, muscular discomfort.

WARNINGS:

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Spray orally, 4 to 6 sprays, at least 30 minutes before bed and 30 minutes after eating. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INACTIVE INGREDIENTS:

Demineralized Water, 25% Organic Ethanol

QUESTIONS:

MFD FOR:

The Wellness Center for Research

and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

PACKAGE DISPLAY LABEL:

Formulated by DR. Theresa Dale

NDC#: 50181-0080-1

Serene

Sleep

DR. DALE'S WELLNESS CENTER

Homeopathic

1 fluid oz. (30 ml)

INGREDIENTS AND APPEARANCE

SERENE SLEEP

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50181-0080
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ESCHSCHOLZIA CALIFORNICA WHOLE (UNII: 9315HN272X) (ESCHSCHOLZIA CALIFORNICA - UNII:9315HN272X)	ESCHSCHOLZIA CALIFORNICA WHOLE	3 [hp_C] in 1 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	3 [hp_C] in 1 mL
ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT)	ARTEMISIA CINA PRE-FLOWERING TOP	6 [hp_C] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_C] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_C] in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	6 [hp_C] in 1 mL
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI)	PULSATILLA PRATENSIS WHOLE	6 [hp_C] in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	30 [hp_C] in 1 mL
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	DIBASIC POTASSIUM PHOSPHATE	30 [hp_C] in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	30 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50181-0080-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/14/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/14/2022

Labeler - The Wellness Center for Research a (832363993)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(50181-0080) , api manufacture(50181-0080) , label(50181-0080) , pack(50181-0080)

Revised: 2/2022

Document Id: 675393a5-8656-4e9d-a6f0-5c7b3186fb67

Set id: 2d5bbd0d-9b50-45ce-aa23-05bd05b54645

Version: 1

Effective Time: 20220214

Search by Drug Name or NDC

NDC 50181-0080-01 Serene Sleep 6; 6; 30; 3; 3; 6; 6; 30; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Details

Serene Sleep 6; 6; 30; 3; 3; 6; 6; 30; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL

Product Information

Package

Package Images

NDC 50181-0080-01 (50181008001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2d5bbd0d-9b50-45ce-aa23-05bd05b54645 Details

ACTIVE INGREDIENTS:

INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN SECTION

DIRECTIONS:

INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE DISPLAY LABEL:

INGREDIENTS AND APPEARANCE

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