FDA.reportPublic FDA data

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
HYOSCYAMUS NIGER6 [hp_X]/1
DATURA STRAMONIUM3 [hp_C]/1
PASSIFLORA INCARNATA TOP4 [hp_C]/1
NUTMEG3 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4WRK2153H3Internal UNII lookup
G6W4F0V8Z3Internal UNII lookup
CLF5YFS11OInternal UNII lookup
AEE24M3MQ9Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dda7a51d-7c2c-67f4-e053-2a95a90a8e72Available on FDA.report

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

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
SleepCalmHYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUMBoirondda7a51d-7c2c-67f4-e053-2a95a90a8e722024-04-23Exact identifier
ndc (product): 0220-9311

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