Home NDC 55714-2568 I-Sleep
Product NDC 55714-2568
11-digit product format 557142568
Labeler code 55714
Product ID 55714-2568_c6a08953-15c4-797d-e053-2a95a90a7a0c
Type HUMAN OTC DRUG
Nonproprietary 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
Dosage form LIQUID
Route ORAL
Labeler Newton Laboratories, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2021-02-01
Substance ANEMONE PULSATILLA; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM BROMIDE; SCUTELLARIA LATERIFLORA WHOLE; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VALERIAN; WORMWOOD
Active strength 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], 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], Increased Histamine Release [PE], Increased IgG Production [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], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-2568-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55714-2568-1 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base I-Sleep
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WORMWOOD 15 [hp_X]/mL SEMECARPUS ANACARDIUM JUICE 15 [hp_X]/mL SILVER NITRATE 15 [hp_X]/mL ARSENIC TRIOXIDE 15 [hp_X]/mL ATROPA BELLADONNA 15 [hp_X]/mL BRYONIA ALBA ROOT 15 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE 15 [hp_X]/mL CAMPHOR (NATURAL) 15 [hp_X]/mL MATRICARIA CHAMOMILLA 15 [hp_X]/mL BLACK COHOSH 15 [hp_X]/mL CINCHONA OFFICINALIS BARK 15 [hp_X]/mL ARABICA COFFEE BEAN 15 [hp_X]/mL CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT 15 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]/mL HOPS 15 [hp_X]/mL HYOSCYAMUS NIGER 15 [hp_X]/mL STRYCHNOS IGNATII SEED 15 [hp_X]/mL POTASSIUM BROMIDE 15 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP 15 [hp_X]/mL ANEMONE PULSATILLA 15 [hp_X]/mL SCUTELLARIA LATERIFLORA WHOLE 15 [hp_X]/mL SEPIA OFFICINALIS JUICE 15 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/mL VALERIAN 15 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 25 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55714-2568-1 I-Sleep 30 mL in 1 BOTTLE, GLASS LIQUID 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55714-2568 I-SLEEP (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) LIQUID [NEWTON LABORATORIES, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20210709_c6a08752-db62-2187-e053-2a95a90af138.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 I-Sleep 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 Newton Laboratories, Inc. c6a08752-db62-2187-e053-2a95a90af138 2021-02-01 Warnings Exact identifier ndc (product): 55714-2568
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55714-2568-1 55714256801 30 mL in 1 BOTTLE, GLASS (55714-2568-1) 30 ml 2021-02-01 0000-00-00 No No Current