FDA.reportPublic FDA data

Serene Sleep

Manufacturer
The Wellness Center for Research a | Apotheca Company
Effective date
2025-06-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:33:55

Label at a glance#

ProductSerene Sleep
Active ingredientESCHSCHOLZIA CALIFORNICA WHOLE, MATRICARIA CHAMOMILLA WHOLE, ARTEMISIA CINA PRE-FLOWERING TOP, ARABICA COFFEE BEAN, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA FLOWERING TOP, PULSATILLA PRATENSIS WHOLE, STRYCHNOS IGNATII SEED, DIBASIC POTASSIUM PHOSPHATE, TOXICODENDRON PUBESCENS LEAF
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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:

OTC - PURPOSE SECTION

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:

WARNINGS SECTION

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

OTC - 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:

DOSAGE & ADMINISTRATION SECTION

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:

INDICATIONS & USAGE SECTION

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.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Organic Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

MFD FOR:

The Wellness Center for Research

and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

PACKAGE DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Formulated by DR. Theresa Dale

NDC#: 50181-0080-1

Serene 

Sleep

DR. DALE'S WELLNESS CENTER

Homeopathic

1 fluid oz. (30 ml)

Serene SleepSerene Sleep

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50181-0080-12025-06-06C16284748780-11030e365-0240-111a-e063-dadaa90a10e2DRUG FACTS:
50181-0080-12024-01-30C16284748780-11030e365-0240-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50181-0080-1Serene Sleep30 mL in 1 BOTTLE, SPRAYSPRAY302

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50181-008050181-0080-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ESCHSCHOLZIA CALIFORNICA WHOLE9315HN272XACTIB
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
ARTEMISIA CINA PRE-FLOWERING TOP28M1820ACTACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
PULSATILLA PRATENSIS WHOLE8E272251DIACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Serene SleepESCHSCHOLTZIA CALIFORNICA, CHAMOMILLA, CINA, COFFEA CRUDA, NUX VOMICA, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, KALI PHOSPHORICUM, RHUS TOXThe Wellness Center for Research a2d5bbd0d-9b50-45ce-aa23-05bd05b546452025-06-06WarningsExact identifier
ndc (package): 50181-0080-1
ndc (product): 50181-0080
ndc11 (package): 50181008001
spl id: 5b0d0301-c85f-4047-960f-ac9c150d827c
spl set id: 2d5bbd0d-9b50-45ce-aa23-05bd05b54645

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.