SleepCalm

Product NDC
0220-9308
Requested package NDC
0220-9308-42
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
GELSEMIUM SEMPERVIRENS ROOT9 [hp_C]/1
POTASSIUM BROMIDE9 [hp_C]/1
HYOSCYAMUS NIGER9 [hp_C]/1
PASSIFLORA INCARNATA FLOWERING TOP9 [hp_C]/1
MATRICARIA CHAMOMILLA WHOLE3 [hp_C]/1
DATURA STRAMONIUM9 [hp_C]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
639KR60Q1QInternal UNII lookup
OSD78555ZMInternal UNII lookup
4WRK2153H3Internal UNII lookup
CLF5YFS11OInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
G6W4F0V8Z3Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
de0b458d-5f0a-78f4-e053-2995a90afe4bAvailable on FDA.report

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SleepCalmMATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUMBoironde0b458d-5f0a-78f4-e053-2995a90afe4b2025-03-07Exact identifier
ndc (package): 0220-9308-42
ndc (product): 0220-9308
ndc11 (package): 00220930842

Packages#

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