I-Sleep

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: I-Sleep
Generic name: ABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANA
Manufacturer: Newton Laboratories, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: c6f053fe-8b59-7226-e053-2995a90a8093
SPL ID: 3f17fee1-6d69-aec2-e063-6294a90a02ed
Version: 2
Effective date: 2025-09-18
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:19:29

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 · 33 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		I-Sleep	openfda.brand_name
generic name		ABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANA	openfda.generic_name
manufacturer name		Newton Laboratories, Inc.	openfda.manufacturer_name
ndc	package	55714-4844-1	openfda.package_ndc
ndc	product	55714-4844	openfda.product_ndc
ndc11	package	55714484401	derived:openfda.package_ndc
spl id		3f17fee1-6d69-aec2-e063-6294a90a02ed	id
spl set id		c6f053fe-8b59-7226-e053-2995a90a8093	set_id
unii		269XH13919	openfda.unii
unii		3SW678MX72	openfda.unii
unii		OSD78555ZM	openfda.unii
unii		F84709P2XV	openfda.unii
unii		QDL83WN8C2	openfda.unii
unii		1NT28V9397	openfda.unii
unii		639KR60Q1Q	openfda.unii
unii		95IT3W8JZE	openfda.unii
unii		1NM3M2487K	openfda.unii
unii		2E32821G6I	openfda.unii
unii		4WRK2153H3	openfda.unii
unii		S7V92P67HO	openfda.unii
unii		N20HL7Q941	openfda.unii
unii		S003A158SB	openfda.unii
unii		7BP4DH5PDC	openfda.unii
unii		WQZ3G9PF0H	openfda.unii
unii		T7J046YI2B	openfda.unii
unii		JWF5YAW3QW	openfda.unii
unii		01G73H6H83	openfda.unii
unii		Y0F0BU8RDU	openfda.unii
unii		CLF5YFS11O	openfda.unii
unii		G0R4UBI2ZZ	openfda.unii
unii		I76KB35JEV	openfda.unii
unii		K73E24S6X9	openfda.unii
unii		21Y9GZ1LZA	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 SECTION WARNINGS: Keep out of reach of children . Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use.

Reported adverse events (FAERS/openFDA)#

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