Melatonin

Manufacturer: BioActive Nutritional, Inc. | Apotheca Company
Effective date: 2017-07-25
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 02:08:53

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 INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Melatonin 6X, 12X, 30X, 12C, 30C.

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol.

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

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

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

HOMEOPATHIC

1 FL OZ (30 ml)

Melatonin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43857-0086-1	Melatonin	30 mL in 1 BOTTLE, DROPPER	LIQUID	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43857-0086	MELATONIN LIQUID [BIOACTIVE NUTRITIONAL, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20170726_cd82eb5d-a44a-4512-ad65-0fffae70d1d0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MELATONIN	ACTIVE INGREDIENT	JL5DK93RCL	3
MELATONIN	ACTIVE MOIETY	JL5DK93RCL	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

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
43857-0086	43857-0086-1

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

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 ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Melatonin	MELATONIN	BioActive Nutritional, Inc.	cd82eb5d-a44a-4512-ad65-0fffae70d1d0	2017-07-25	Warnings	Exact identifier ndc (package): 43857-0086-1 ndc (product): 43857-0086 ndc11 (package): 43857008601 spl id: e189499d-9da3-43fc-8a0b-9d5dd0923b11 spl set id: cd82eb5d-a44a-4512-ad65-0fffae70d1d0

Reported adverse events (FAERS/openFDA)#

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