SleepCalm

Product NDC
0220-9311
11-digit product format
002209311
Labeler code
0220
Product ID
0220-9311_16c77587-39d7-31cf-e063-6294a90a7f22
Type
HUMAN OTC DRUG
Nonproprietary name
HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM
Dosage form
PELLET
Route
ORAL
Labeler
Boiron
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-04-27
Substance
DATURA STRAMONIUM; HYOSCYAMUS NIGER; NUTMEG; PASSIFLORA INCARNATA TOP
Active strength
6; 3; 4; 3 [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], 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
SleepCalm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DATURA STRAMONIUM6 [hp_X]/1
HYOSCYAMUS NIGER3 [hp_C]/1
NUTMEG4 [hp_C]/1
PASSIFLORA INCARNATA TOP3 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG6W4F0V8Z3, 4WRK2153H3, AEE24M3MQ9, CLF5YFS11O

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9311-41SleepCalm80 in 1 TUBEPELLET803
0220-9311-42SleepCalm2 in 1 BOXPELLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9311SLEEPCALM (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM) PELLET [BOIRON]3Current NDC, Legacy NDC, 2 package rows20240430_dda7a51d-7c2c-67f4-e053-2a95a90a8e72.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-9311-410022093114180 in 1 TUBEHistorical
0220-9311-42002209311422 TUBE in 1 BOX (0220-9311-42) / 80 PELLET in 1 TUBE (0220-9311-41) 2 tube2022-04-270000-00-00NoNoCurrent