Melatonin

Manufacturer: BioActive Nutritional, Inc. | Apotheca Company
Effective date: 2024-10-17
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:28:15

Label at a glance#

ProductMelatonin

Active ingredientMELATONIN

Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Melatonin 6X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of fatigue, irritability, insomnia, and exhaustion.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care 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 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

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of fatigue, irritability, insomnia, and exhaustion.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

MELATONIN 6X

HOMEOPATHIC

1 FL OZ (30 ml)

Melatonin 6X

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43857-0511-1	2024-10-17	C162847	48780-1	ba0f9c33-43c5-a910-e053-dadaa90a0b85	DRUG FACTS:
43857-0511-1	2021-01-29	C162847	48780-1	ba0f9c33-43c5-a910-e053-dadaa90a0b85	DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43857-0511-1	Melatonin	30 mL in 1 BOTTLE, DROPPER	LIQUID	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43857-0511	MELATONIN LIQUID [BIOACTIVE NUTRITIONAL, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20241019_8951e5e9-5d8f-4808-b247-208760fae656.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

Melatonin
WATER
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43857-0511	43857-0511-1

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
Name	UNII	Kind
MELATONIN	JL5DK93RCL	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Melatonin	MELATONIN	BioActive Nutritional, Inc.	8951e5e9-5d8f-4808-b247-208760fae656	2024-10-17	Warnings	Exact identifier ndc (package): 43857-0511-1 ndc (product): 43857-0511 ndc11 (package): 43857051101 spl id: adcac0e0-d21f-4124-b951-e6913591ac9f spl set id: 8951e5e9-5d8f-4808-b247-208760fae656

Reported adverse events (FAERS/openFDA)#

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