FDA.reportPublic FDA data

Sleep Tight

Manufacturer
Dr. Donna Restivo DC | Apotheca Company
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:25:44

Label at a glance#

ProductSleep Tight
Active ingredientADENOSINE TRIPHOSPHATE DISODIUM, PANTOTHENIC ACID, SUS SCROFA PINEAL GLAND, LACTIC ACID, L-, UBIDECARENONE, TRYPTOPHAN, MELATONIN, PYRROLE, ARSENIC TRIOXIDE, AVENA SATIVA FLOWERING TOP, MATRICARIA CHAMOMILLA WHOLE, ARABICA COFFEE BEAN, MERCURIC CHLORIDE, PASSIFLORA INCARNATA FLOWERING TOP, SILICON DIOXIDE, ZINC VALERATE DIHYDRATE, SHIGELLA DYSENTERIAE, SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS
Label structure9 sections

Dosage and administration

10 drops under the tongue, 3 to 6 times per day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Adenosinum Triphosphoricum Dinatrum 8X, Pantothenic Acid 8X, Pineal Gland (Suis) 8X, Sarcolacticum Acidum 8X, Ubidecarenonum 8X, L-Tryptophan 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Melatonin 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Pyrrole 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Arsenicum Album 10X, 30X, 1LM, Avena Sativa 10X, 30X, 1LM, Chamomilla 10X, 30X, 1LM, Coffea Cruda 10X, 30X, 1LM, Mercurius Corrosivus 10X, 30X, 1LM, Passiflora Incarnata 10X, 30X, 1LM, Silicea 10X, 30X, 1LM, Zincum Valerianicum 10X, 30X, 1LM, Dysentery Bacillus 30C, Gaertner Bacillus (Bach) 30C.

HOMEOPATHIC INDICATIONS:

OTC - PURPOSE SECTION

For the temporary relief of sleeplessness such as tiredness, fatigue, and lack of energy.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

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

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

Tamper seal: Sealed for your protection.

Do not use if seal is broken or missing.

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 contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops under the tongue, 3 to 6 times per day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

HOMEOPATHIC INDICATIONS:

INDICATIONS & USAGE SECTION

For the temporary relief of sleeplessness such as tiredness, fatigue, and lack of energy.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

demineralized water, 25% ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by Dr. Donna Restivo DC, Wellness Consultant

822 South Lake Blvd. Mahopac, New York 10541

www.mahopacmassage.com • (845) 628-6286

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DR. DONNA RESTIVO DC

WELLNESS CONSULTANT

NDC 62185-0024-1

HOMEOPATHIC

Brain SUPPORT

1 FL OZ (30 ml)

Sleep TightSleep Tight

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62185-0024-1Sleep Tight30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62185-0024SLEEP TIGHT (ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)) LIQUID [DR. DONNA RESTIVO DC]4Current NDC, Legacy NDC, 1 package rows20240119_b5955fbc-71f8-4fe0-9df0-42f337ab9c7d.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62185-002462185-0024-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADENOSINE TRIPHOSPHATE DISODIUM5L51B4DR1GACTIB
PANTOTHENIC ACID19F5HK2737ACTIB
SUS SCROFA PINEAL GLAND050QZ2EDK7ACTIB
LACTIC ACID, L-F9S9FFU82NACTIB
UBIDECARENONEEJ27X76M46ACTIB
TRYPTOPHAN8DUH1N11BXACTIB
MELATONINJL5DK93RCLACTIB
PYRROLE86S1ZD6L2CACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ZINC VALERATE DIHYDRATEMN0RX54EQAACTIB
SHIGELLA DYSENTERIAE1EP6R5562JACTIB
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDISY3V16D4PV4ACTIB
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
Sleep TightADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Dr. Donna Restivo DCb5955fbc-71f8-4fe0-9df0-42f337ab9c7d2024-01-18WarningsExact identifier
ndc (package): 62185-0024-1
ndc (product): 62185-0024
ndc11 (package): 62185002401
spl id: df3e9d6d-16f0-4d29-bede-385f8cf84cbb
spl set id: b5955fbc-71f8-4fe0-9df0-42f337ab9c7d

Reported adverse events (FAERS/openFDA)#

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