FDA.reportPublic FDA data

soothe and sleep

Manufacturer
Siddha Flower Essences LLC
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:11:39

Label at a glance#

Productsoothe and sleep
Active ingredientAESCULUS HIPPOCASTANUM FLOWER, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HELIANTHEMUM NUMMULARIUM FLOWER, MIMULUS GUTTATUS FLOWERING TOP, SODIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM SULFATE, PHOSPHORUS, VERBENA OFFICINALIS FLOWERING TOP
Label structure10 sections

Indications and uses

temporarily relieves symptoms of difficulty falling asleep restlessness sleepless after excitement waking and trouble going back to sleep nightmares indications are based on homeopathic materia medica, not clinical tests.

Dosage and administration

Children 6 years and older 4 sprays in mouth at bedtime for maximum effect 4 sprays in mouth one hour before bed and again at bedtime can also be used after waking up in the middle of the night use 5 days per week until symptoms are relieved children 2 years to under 6 years 2 sprays in mouth as needed children under 2 years consult a doctor may also be applied externally to the top of the child's head

Storage and handling

do not use if plastic seal around cap is broken or missing. store in a cool, dry place.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Each dose contains equal parts of:

Aesculus hippocastanum, flos (White Chestnut) 5X HPUS

Chamomilla 6C HPUS

Ferr Phos 12X HPUS

Helianthemum nummularium, flos (Rock Rose) 5X HPUS

Mimulus guttatus, flos (Mimulus) 5X HPUS

Nat Mur 6X HPUS

Nat Phos 6X HPUS

Nat Sulph 6X HPUS

Phosphorus 6C HPUS

Verbena officinalis, flos (Vervain) 5X HPUS

Purpose

OTC - PURPOSE SECTION

Each dose contains equal parts of:

Aesculus hippocastanum, flos (White Chestnut) 5X HPUS.........can't sleep enough because thoughts going around in head

Chamomilla 6C HPUS.............................................................restlessness, irritability; cries self to sleep

Ferr Phos 12X HPUS..............................................................restless, sleepless

Helianthemum nummularium, flos (Rock Rose) 5X HPUS...........nerves are weak; overreact and feel helpless

Mimulus guttatus, flos (Mimulus) 5X HPUS...............................anxieties cause inner tension

Nat Mur 6X HPUS...................................................................difficulty falling asleep; nightmares

Nat Phos 6X HPUS................................................................sleepless after excitement; sleepless from 12-3 am

Nat Sulph 6X HPUS................................................................uneasy sleep with anxious dream; tired in the morning

Phosphorus 6C HPUS.............................................................frequent waking; trouble going back to sleep; falls asleep late

Verbena officinalis, flos (Vervain) 5X HPUS...............................children are hyperactive and won't go to bed at night

The letters HPUS indicate ingredients are in the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves symptoms of
  • difficulty falling asleep
  • restlessness
  • sleepless after excitement
  • waking and trouble going back to sleep
  • nightmares


indications are based on homeopathic materia medica, not clinical tests.

Warnings

WARNINGS SECTION

Stop use and ask a doctor if symptoms persist or worsen

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • Children 6 years and older 4 sprays in mouth at bedtime
  • for maximum effect 4 sprays in mouth one hour before bed and again at bedtime
  • can also be used after waking up in the middle of the night
  • use 5 days per week until symptoms are relieved

children 2 years to under 6 years

2 sprays in mouth as needed

children under 2 years
consult a doctor
  • may also be applied externally to the top of the child's head

Other Information

STORAGE AND HANDLING SECTION

  • do not use if plastic seal around cap is broken or missing.
  • store in a cool, dry place.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Chamomile*, Chaparral*, Lemon Balm*, Licorice*, Mock Orange*, Natural Flavor, Purified Water, Valerian*


*flower essence

DESCRIPTION SECTION

Questions or Comments?

Call 800.570.0021

Between 9am-5pm PST

info@siddhaflowers.com

siddhaflowers.com

MFD by Siddha Flower Essences
Oxnard, CA 93030

Made in USA

Side Panel

DESCRIPTION SECTION

flower essences and homeopathy:

  •    Jump start your child's natural ability to heal
  •    Natural, safe and non-habit forming
  •    No contraindications.  May be effectively used with drugs and other supplements
  •    Alcohol, sugar, dairy and gluten free
  • Prepared in purified water with natural preservatives
  •    Blends time-tested natural medicine with modern technology
  •    5 week supply



siddha kids

stress relief
attention and focus
soothe and sleep
temper tamer

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100% natural     -     no alcohol

siddha cell salts + flower essences

kids 2+

soothe and sleep

Difficulty Falling Asleep
Restless and Sleepless
Anxious Dreams



sugar, dairy and gluten free

Homeopathic Remedy
1 US fl oz (29.6mL)

Soothe and Sleep CartonSoothe and Sleep Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69779-018-012026-01-01C16284748780-11030e365-136e-111a-e063-dadaa90a10e2Drug Facts
69779-018-022026-01-01C16284748780-11030e365-136e-111a-e063-dadaa90a10e2Drug Facts
69779-018-012024-01-30C16284748780-11030e365-136e-111a-e063-dadaa90a10e2Drug Facts
69779-018-022024-01-30C16284748780-11030e365-136e-111a-e063-dadaa90a10e2Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69779-018SOOTHE AND SLEEP (AESCULUS HIPPOCASTANUM, FLOS, CHAMOMILLA, FERR PHOS, HELIANTHEMUM NUMMULARIUM, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, NAT SULPH, PHOSPHORUS, VERBENA OFFICINALIS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]3Legacy NDC20220126_1bec3bf3-82e4-4eb4-8c7f-d0105b88b575.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AESCULUS HIPPOCASTANUM FLOWERACTIVE INGREDIENTKK0Z92II8M1
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F71
HELIANTHEMUM NUMMULARIUM FLOWERACTIVE INGREDIENT51BRR32WPP1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ1
MIMULUS GUTTATUS FLOWERING TOPACTIVE INGREDIENT192426I5JU1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEACTIVE INGREDIENT70WT22SF4B1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
VERBENA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT311PNK9CDZ1
AESCULUS HIPPOCASTANUM FLOWERACTIVE MOIETYKK0Z92II8M1
FERROSOFERRIC PHOSPHATEACTIVE MOIETY91GQH8I5F71
HELIANTHEMUM NUMMULARIUM FLOWERACTIVE MOIETY51BRR32WPP1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ1
MIMULUS GUTTATUS FLOWERING TOPACTIVE MOIETY192426I5JU1
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7501
VERBENA OFFICINALIS FLOWERING TOPACTIVE MOIETY311PNK9CDZ1
LICORICEINACTIVE INGREDIENT61ZBX548831
MATRICARIA RECUTITA FLOWERING TOPINACTIVE INGREDIENT3VNC7T6Z021
MELISSA OFFICINALIS FLOWERING TOPINACTIVE INGREDIENT5JQG17B06J1
VALERIANINACTIVE INGREDIENTJWF5YAW3QW1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69779-01869779-018-01, 69779-018-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
MATRICARIA RECUTITA FLOWERING TOP3VNC7T6Z02IACT
MELISSA OFFICINALIS FLOWERING TOP5JQG17B06JIACT
LICORICE61ZBX54883IACT
WATER059QF0KO0RIACT
VALERIANJWF5YAW3QWIACT
AESCULUS HIPPOCASTANUM FLOWERKK0Z92II8MACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
HELIANTHEMUM NUMMULARIUM FLOWER51BRR32WPPACTIB
MIMULUS GUTTATUS FLOWERING TOP192426I5JUACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BACTIB
SODIUM SULFATE0YPR65R21JACTIB
PHOSPHORUS27YLU75U4WACTIB
VERBENA OFFICINALIS FLOWERING TOP311PNK9CDZACTIB

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
474d606a-d50b-31be-e063-6394a90ad73e1bec3bf3-82e4-4eb4-8c7f-d0105b88b5752025-12-31WarningsExact identifier
spl set id: 1bec3bf3-82e4-4eb4-8c7f-d0105b88b575

Reported adverse events (FAERS/openFDA)#

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