Home NDC 43689-0018 Sleep Assist
Product NDC 43689-0018
11-digit product format 436890018
Labeler code 43689
Product ID 43689-0018_78240a31-a7d1-4474-86cb-bf32a9667488
Type HUMAN OTC DRUG
Nonproprietary name Chamomilla, Coffea Cruda, Avena Sativa, Nux Vomica, Passiflora Incarnata
Dosage form TABLET, ORALLY DISINTEGRATING
Route ORAL
Labeler The Magni Company
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2023-06-19
Substance ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED
Active strength 4; 6; 4; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
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 Additional Listing Data#
Finished product Yes
Brand name base Sleep Assist
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MATRICARIA CHAMOMILLA WHOLE 4 [hp_X]/1 ARABICA COFFEE BEAN 6 [hp_X]/1 AVENA SATIVA FLOWERING TOP 4 [hp_X]/1 STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/1 PASSIFLORA INCARNATA FLOWERING TOP 6 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43689-0018-1 Sleep Assist 125 in 1 BOTTLE TABLET, ORALLY DISINTEGRATING 125 2 43689-0018-2 Sleep Assist 1 in 1 CARTON TABLET, ORALLY DISINTEGRATING 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43689-0018 SLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY] 2 Current NDC, 2 package rows 20240807_a7e428d3-9460-48d0-9c8d-1e8846bec857.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 Assist CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA The Magni Company a7e428d3-9460-48d0-9c8d-1e8846bec857 2024-08-06 Warnings Exact identifier ndc (product): 43689-0018
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43689-0018-1 43689001801 125 in 1 BOTTLE Historical 43689-0018-2 43689001802 1 BOTTLE in 1 CARTON (43689-0018-2) / 125 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43689-0018-1) 1 bottle 2023-06-19 No No Current