Insomnia

Manufacturer
Liddell Laboratories, Inc. | Apotheca Company
Effective date
2023-10-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:22:58

Label at a glance#

ProductInsomnia
Active ingredientAQUILEGIA VULGARIS, AVENA SATIVA FLOWERING TOP, MATRICARIA CHAMOMILLA WHOLE, ARABICA COFFEE BEAN, CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT, HOPS, HYPERICUM PERFORATUM WHOLE, DIBASIC POTASSIUM PHOSPHATE, MELATONIN, MELISSA OFFICINALIS WHOLE, SODIUM CHLORIDE, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN
Label structure9 sections

Indications and uses

May temporarily relieve symptoms associated with occasional sleeplessness caused by: anxiety, restlessness, stress, and caffeine sensitivity** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

Adults and children over 12: Two sprays under the tongue prior to bedtime and when sleep is interrupted by restlessness. Children under 12: Consult a doctor prior to use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each spray) 7.69% of Aquilegia Vulgaris 2X, Avena Sativa 2X, Chamomilla 2X, Coffea Cruda 6X, Cypripedium Pubescens 8X, Humulus Lupulus 3X, Hypericum Perforatum 6X, Kali Phosphoricum 12X, Melatonin 6X, Melissa Officinalis 3X, Natrum Muriaticum 30C, Passiflora Incarnata 2X, Valeriana Officinalis 2X.

USES:

OTC - PURPOSE SECTION

May temporarily relieve symptoms associated with occasional sleeplessness caused by:

anxiety, restlessness, stress, and caffeine sensitivity**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

See box.

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist for more than 7 days, worsen, or if new symptoms occur.

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

If pregnant or breast feeding, ask a doctor before using product.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Store at room temperature.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12: Two sprays under the tongue prior to bedtime and when sleep is interrupted by restlessness.

Children under 12: Consult a doctor prior to use.

USES:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms associated with occasional sleeplessness caused by:

anxiety, restlessness, stress, and caffeine sensitivity**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Organic alcohol 20% v/v, Purified water.

QUESTIONS:

OTC - QUESTIONS SECTION

DIST. BY:

LIDDELL LABORATORIES INC.

201 APPLE BLVD.

WOODBINE, IA 51579

WWW.LIDDELL.NET

1-800-460-7733

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL SPRAYS

LIDDELL
LABORATORIES

EST. 1994

32 Ins
Insomnia

May relieve symptoms associated
with occasional sleeplessness
caused by anxiety, restlessness,
stress, or caffeine sensitivity.

HOMEOPATHIC
DOCTOR FORMULATED

Readily absorbed. Safe.
No known side effects. Easy to use.

1.0 FL OZ (30 ml)

Insomnia lblInsomnia lbl

Insomnia ctnInsomnia ctn

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0272-22023-10-31C16284748780-1d6a99b39-67d8-a426-e053-dadaa90af4c2DRUG FACTS:
50845-0272-22022-01-28C16284748780-1d6a99b39-67d8-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0272-1Insomnia30 mL in 1 BOTTLE, SPRAYSPRAY302
50845-0272-2Insomnia1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0272INSOMNIA (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) SPRAY [LIDDELL LABORATORIES, INC.]2Current NDC, Legacy NDC, 2 package rows20231101_18c15f17-1a16-4595-9d23-20353363cd72.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50845-027250845-0272-1, 50845-0272-2

Ingredients#

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

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

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
InsomniaAQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISLiddell Laboratories, Inc.18c15f17-1a16-4595-9d23-20353363cd722023-10-31WarningsExact identifier
ndc (package): 50845-0272-2
ndc (package): 50845-0272-1
ndc (product): 50845-0272
ndc11 (package): 50845027201
ndc11 (package): 50845027202
spl id: b5a38025-d7f8-4589-9c07-553bdca09e1f
spl set id: 18c15f17-1a16-4595-9d23-20353363cd72

Reported adverse events (FAERS/openFDA)#

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