Home FDA labels cc630075-d315-46fe-a50d-3fb7f0215eb4 SleepEase 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 SleepEase
Generic name AQUILEGIA, AVENA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM, HUMULUS, KALI PHOS, PASSIFLORA, VALERIANA, ZINC MET
Manufacturer Eight & Company L.L.C
Product type HUMAN OTC DRUG
SPL set ID 9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6
SPL ID cc630075-d315-46fe-a50d-3fb7f0215eb4
Version 6
Effective date 2025-12-18
Source export date 2026-09-28
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:26:29 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 · 18 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name SleepEase openfda.brand_name generic name AQUILEGIA, AVENA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM, HUMULUS, KALI PHOS, PASSIFLORA, VALERIANA, ZINC MET openfda.generic_name manufacturer name Eight & Company L.L.C openfda.manufacturer_name ndc package 61096-2001-1 openfda.package_ndc ndc product 61096-2001 openfda.product_ndc ndc11 package 61096200101 derived:openfda.package_ndc spl id cc630075-d315-46fe-a50d-3fb7f0215eb4 id spl set id 9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6 set_id unii CI71S98N1Z openfda.unii unii 3SW678MX72 openfda.unii unii 8POZ61U1G2 openfda.unii unii JWF5YAW3QW openfda.unii unii 01G73H6H83 openfda.unii unii MA9CQJ3F7F openfda.unii unii CLF5YFS11O openfda.unii unii G0R4UBI2ZZ openfda.unii unii J41CSQ7QDS 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: If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.