FDA.reportPublic FDA data

THE FLOWER REMEDY Peaceful Night

Manufacturer
The Flower Remedy
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:36:13

Label at a glance#

ProductTHE FLOWER REMEDY Peaceful Night
Active ingredientPRUNUS CERASIFERA FLOWER, CLEMATIS VITALBA FLOWER, ULMUS MINOR FLOWERING TWIG, IMPATIENS GLANDULIFERA FLOWER, QUERCUS ROBUR FLOWER, HELIANTHEMUM NUMMULARIUM FLOWER, AESCULUS HIPPOCASTANUM FLOWER, STRYCHNOS IGNATII SEED
Label structure8 sections

Indications and uses

Relief from occasional sleeplessness

Dosage and administration

Place 4 drops under the tongue 30-60 minutes before bed and as needed upon undesired awakening from sleep

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Each 30ml bottle contains equal parts of the active ingredients:
Each 5X (HPUS) Cherry Plum (Prunus cerasifera), Clematis (Clematis vitalba), Elm (Ulmus procera), Impatiens (Impatiens glandulifera), Oak (Quercus robur), Rock Rose (Helianthemum nummularium), White Chestnut (Aesculus hippocastanum), 200C (HPUS) Ignatia Amara

Purpose:

OTC - PURPOSE SECTION

Sleep Aid

USES:

INDICATIONS & USAGE SECTION

Relief from occasional sleeplessness

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Place 4 drops under the tongue 30-60 minutes before bed and as needed upon undesired awakening from sleep

WARNINGS:

WARNINGS SECTION

If pregnant or breast feeding, consult a physician before use. Consult a health care provider for children under 12. Consult a physician if symptoms persist for more than 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

water, alcohol

SPL UNCLASSIFIED SECTION

THE FLOWER REMEDY
NATURAL PRODUCTS

Homeopathic Sleep Aid

Homeopathic contains 27% alcohol

*The claims for this product are based upon traditional homeopathic practice, not accepted medical practices. They have not been reviewed by the Food and Drug Administration.

Manufactured and distributed by
The Flower Remedy
2921 Carlisle Blvd NE Suite 209
Albuquerque, NM 87110
(505) 263-7248

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130709930994556GTIN-13: 0709930994556
EAN-13: 0709930994556
GTIN-12: 709930994556
UPC-A: 709930994556
GTIN storage (14 digits): 00709930994556		8118310130-4.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81183-101-302025-12-17C16284748780-11030e365-4c32-111a-e063-dadaa90a10e2THE FLOWER REMEDY NATURAL PRODUCTS Peaceful Night
81183-101-302025-01-30C16284748780-11030e365-4c32-111a-e063-dadaa90a10e2THE FLOWER REMEDY NATURAL PRODUCTS Peaceful Night
81183-101-302024-12-06C16284748780-11030e365-4c32-111a-e063-dadaa90a10e2THE FLOWER REMEDY NATURAL PRODUCTS Peaceful Night
81183-101-302024-07-30C16284748780-11030e365-4c32-111a-e063-dadaa90a10e2THE FLOWER REMEDY NATURAL PRODUCTS Peaceful Night
81183-101-302024-01-30C16284748780-11030e365-4c32-111a-e063-dadaa90a10e2THE FLOWER REMEDY NATURAL PRODUCTS Peaceful Night

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81183-101-30THE FLOWER REMEDY Peaceful Night30 mL in 1 BOTTLE, GLASSLIQUID302

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81183-10181183-101-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRUNUS CERASIFERA FLOWER0KD7R09EASACTIB
CLEMATIS VITALBA FLOWER7SCP4N87CIACTIB
ULMUS MINOR FLOWERING TWIGJ3O020I532ACTIB
IMPATIENS GLANDULIFERA FLOWERAJU5O1A5ZVACTIB
QUERCUS ROBUR FLOWERML644HED2VACTIB
HELIANTHEMUM NUMMULARIUM FLOWER51BRR32WPPACTIB
AESCULUS HIPPOCASTANUM FLOWERKK0Z92II8MACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
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
THE FLOWER REMEDY Peaceful NightPRUNUS CERASIFERA, CLEMATIS VITALBA, ULMUS PROCERA, IMPATIENS GLANDULIFERA, QUERCUS ROBUR, HELIANTHEMUM NUMMULARIUM, AESCULUS HIPPOCASTANUM, IGNATIA AMARAThe Flower Remedya0f2b6db-62a4-43b7-88f2-09b2a3c567de2025-12-03WarningsExact identifier
ndc (package): 81183-101-30
ndc (product): 81183-101
ndc11 (package): 81183010130
spl id: 98e0c38e-1c39-4bb6-ac67-e3afe68aaf8c
spl set id: a0f2b6db-62a4-43b7-88f2-09b2a3c567de

Reported adverse events (FAERS/openFDA)#

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