Home NDC 61096-2001 SleepEase
Product NDC 61096-2001
11-digit product format 610962001
Labeler code 61096
Product ID 61096-2001_cc630075-d315-46fe-a50d-3fb7f0215eb4
Type HUMAN OTC DRUG
Nonproprietary name Aquilegia, Avena, Chamomilla, Coffea cruda, Cypripedium, Humulus, Kali phos, Passiflora, Valeriana, Zinc met
Dosage form LIQUID
Route ORAL
Labeler Eight & Company L.L.C
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2019-04-24
Substance AQUILEGIA VULGARIS; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; DIBASIC POTASSIUM PHOSPHATE; HOPS; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; ZINC
Active strength 4; 200; 4; 4; 12; 4; 4; 4; 4; 12 [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL
Pharmacologic classes Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base SleepEase
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AQUILEGIA VULGARIS 4 [hp_X]/41mL AVENA SATIVA FLOWERING TOP 200 [hp_C]/41mL MATRICARIA CHAMOMILLA WHOLE 4 [hp_X]/41mL ARABICA COFFEE BEAN 4 [hp_X]/41mL CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT 12 [hp_X]/41mL HOPS 4 [hp_X]/41mL DIBASIC POTASSIUM PHOSPHATE 4 [hp_X]/41mL PASSIFLORA INCARNATA FLOWERING TOP 4 [hp_X]/41mL VALERIAN 4 [hp_X]/41mL ZINC 12 [hp_X]/41mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61096-2001-1 SleepEase 1 in 1 CARTON LIQUID 1 6 61096-2001-1 SleepEase 41 mL in 1 BOTTLE, SPRAY LIQUID 41 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61096-2001 SLEEPEASE (AQUILEGIA, AVENA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM, HUMULUS, KALI PHOS, PASSIFLORA, VALERIANA, ZINC MET) LIQUID [EIGHT & COMPANY L.L.C] 5 Current NDC, Legacy NDC, 2 package rows 20250519_9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6.zip
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 SleepEase AQUILEGIA, AVENA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM, HUMULUS, KALI PHOS, PASSIFLORA, VALERIANA, ZINC MET Eight & Company L.L.C 9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6 2025-12-18 Warnings Exact identifier ndc (product): 61096-2001
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61096-2001-1 61096200101 1 BOTTLE, SPRAY in 1 CARTON (61096-2001-1) / 41 mL in 1 BOTTLE, SPRAY 2019-04-24 0000-00-00 No No Current