Home NDC 70163-0002 Sleep HP
Product NDC 70163-0002
11-digit product format 701630002
Labeler code 70163
Product ID 70163-0002_f934b0f4-d90e-42ff-9226-839dd03bcb38
Type HUMAN OTC DRUG
Nonproprietary name Arsenicum Album, Avena Sativa, Coffea Cruda, Kali Carbonicum, Magnesia Carbonica, Nux Vomica, Passiflora Incarnata, Sepia, Valeriana Officinalis
Dosage form LIQUID
Route ORAL
Labeler Grato Holdings, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2020-11-30
Substance ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; SEPIA OFFICINALIS JUICE; VALERIAN
Active strength 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], 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], Seed Storage Proteins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sleep HP
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARSENIC TRIOXIDE 30 [hp_X]/mL AVENA SATIVA FLOWERING TOP 30 [hp_X]/mL ARABICA COFFEE BEAN 30 [hp_X]/mL POTASSIUM CARBONATE 30 1/mL MAGNESIUM CARBONATE 30 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED 30 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP 30 [hp_X]/mL SEPIA OFFICINALIS JUICE 30 [hp_X]/mL VALERIAN 30 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 9 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 70163-0002-1 Sleep HP 30 mL in 1 BOTTLE, DROPPER LIQUID 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70163-0002 SLEEP HP (ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS) LIQUID [GRATO HOLDINGS, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20210303_90e8553a-cfa9-4bb1-a398-3242a4e7456b.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 Sleep HP ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS Grato Holdings, Inc. 90e8553a-cfa9-4bb1-a398-3242a4e7456b 2020-11-30 Warnings Exact identifier ndc (product): 70163-0002
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70163-0002-1 70163000201 30 mL in 1 BOTTLE, DROPPER (70163-0002-1) 30 ml 2020-11-30 0000-00-00 No No Current