Melatonin Phenolic

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:28:31

Label at a glance#

ProductMelatonin Phenolic
Active ingredientMELATONIN
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 20% of Melatonin 6X, 12X, 30X, 12C, 30C.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms associated with reactions to melatonin such as sleeplessness.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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 tamper evident seal is broken or missing.

Store in a cool, dry place.

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

Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional.

Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms associated with reactions to melatonin such as sleeplessness.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
MELATONIN
PHENOLIC
1 fl. oz. (30 ml)

Melatonin PhenolicMelatonin Phenolic

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0247-12024-10-28C16284748780-1ba0f9c33-5b7a-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0247-12023-01-30C16284748780-1ba0f9c33-5b7a-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0247-12021-06-16C16284748780-1ba0f9c33-5b7a-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0247-12021-01-29C16284748780-1ba0f9c33-5b7a-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0247-1Melatonin Phenolic30 mL in 1 BOTTLE, DROPPERLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0247MELATONIN PHENOLIC ( MELATONIN) LIQUID [ENERGIQUE, INC.]5Current NDC, Legacy NDC, 1 package rows20241030_895cb8a5-33ea-4764-86a6-1da513dcd2c1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MELATONINACTIVE INGREDIENTJL5DK93RCL1
MELATONINACTIVE MOIETYJL5DK93RCL1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-024744911-0247-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MELATONINJL5DK93RCLACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Melatonin PhenolicMELATONINEnergique, Inc.895cb8a5-33ea-4764-86a6-1da513dcd2c12024-10-28WarningsExact identifier
ndc (package): 44911-0247-1
ndc (product): 44911-0247
ndc11 (package): 44911024701
spl id: adde04ad-3287-4fe9-b9e5-6385123b7da3
spl set id: 895cb8a5-33ea-4764-86a6-1da513dcd2c1

Reported adverse events (FAERS/openFDA)#

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