Melatonin

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Melatonin
Generic name: MELATONIN
Manufacturer: BioActive Nutritional, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 8951e5e9-5d8f-4808-b247-208760fae656
SPL ID: adcac0e0-d21f-4124-b951-e6913591ac9f
Version: 2
Effective date: 2024-10-17
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:04:06

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 9 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Melatonin	openfda.brand_name
generic name		MELATONIN	openfda.generic_name
manufacturer name		BioActive Nutritional, Inc.	openfda.manufacturer_name
ndc	package	43857-0511-1	openfda.package_ndc
ndc	product	43857-0511	openfda.product_ndc
ndc11	package	43857051101	derived:openfda.package_ndc
spl id		adcac0e0-d21f-4124-b951-e6913591ac9f	id
spl set id		8951e5e9-5d8f-4808-b247-208760fae656	set_id
unii		JL5DK93RCL	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: 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.

Reported adverse events (FAERS/openFDA)#

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