SleepCalm

Product NDC
0220-9308
11-digit product format
002209308
Labeler code
0220
Product ID
0220-9308_2fc2e0fd-e440-d3f5-e063-6394a90a8473
Type
HUMAN OTC DRUG
Nonproprietary name
MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM
Dosage form
PELLET
Route
ORAL
Labeler
Boiron
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-05-02
Substance
DATURA STRAMONIUM; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM BROMIDE
Active strength
9; 9; 9; 9; 3; 9 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1
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 STRAMONIUM9 [hp_C]/1
GELSEMIUM SEMPERVIRENS ROOT9 [hp_C]/1
HYOSCYAMUS NIGER9 [hp_C]/1
MATRICARIA CHAMOMILLA WHOLE9 [hp_C]/1
PASSIFLORA INCARNATA FLOWERING TOP3 [hp_C]/1
POTASSIUM BROMIDE9 [hp_C]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG6W4F0V8Z3, 639KR60Q1Q, 4WRK2153H3, G0R4UBI2ZZ, CLF5YFS11O, OSD78555ZM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9308-41SleepCalm80 in 1 TUBEPELLET803
0220-9308-42SleepCalm2 in 1 BOXPELLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9308SLEEPCALM (MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM) PELLET [BOIRON]3Current NDC, Legacy NDC, 2 package rows20250312_de0b458d-5f0a-78f4-e053-2995a90afe4b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-9308-410022093084180 in 1 TUBEHistorical
0220-9308-42002209308422 TUBE in 1 BOX (0220-9308-42) / 80 PELLET in 1 TUBE (0220-9308-41) 2 tube2022-05-020000-00-00NoNoCurrent