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
IngredientStrength
ARABICA COFFEE BEAN4 [hp_X]/1
AVENA SATIVA FLOWERING TOP6 [hp_X]/1
MATRICARIA CHAMOMILLA WHOLE4 [hp_X]/1
PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]/1
STRYCHNOS NUX-VOMICA SEED6 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3SW678MX72, MA9CQJ3F7F, G0R4UBI2ZZ, CLF5YFS11O, 269XH13919

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43689-0018-1Sleep Assist125 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1252
43689-0018-2Sleep Assist1 in 1 CARTONTABLET, ORALLY DISINTEGRATING12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43689-0018SLEEP ASSIST (CHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATA) TABLET, ORALLY DISINTEGRATING [THE MAGNI COMPANY]2Current NDC, 2 package rows20240807_a7e428d3-9460-48d0-9c8d-1e8846bec857.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43689-0018-143689001801125 in 1 BOTTLEHistorical
43689-0018-2436890018021 BOTTLE in 1 CARTON (43689-0018-2) / 125 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43689-0018-1) 1 bottle2023-06-19NoNoCurrent