FDA.reportPublic FDA data

SleepCalm Kids

Product NDC
0220-9309
11-digit product format
002209309
Labeler code
0220
Product ID
0220-9309_1f452ffb-58f3-8ade-e063-6394a90ad0c8
Type
HUMAN OTC DRUG
Nonproprietary name
MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM
Dosage form
LIQUID
Route
ORAL
Labeler
Boiron
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-09-10
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 Kids
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DATURA STRAMONIUM9 [hp_C]/1
POTASSIUM BROMIDE9 [hp_C]/1
PASSIFLORA INCARNATA FLOWERING TOP3 [hp_C]/1
MATRICARIA CHAMOMILLA WHOLE9 [hp_C]/1
GELSEMIUM SEMPERVIRENS ROOT9 [hp_C]/1
HYOSCYAMUS NIGER9 [hp_C]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aef7b774-355a-3fb8-e053-2a95a90a268cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9309-092023-02-14C16284748780-1f386c64a-2b7c-0266-e053-dadaa90a7c1aSleepCalm Kids
0220-9309-092023-01-30C16284748780-1f386c64a-2b7c-0266-e053-dadaa90a7c1aSleepCalm Kids

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9309-07SleepCalm Kids5 in 1 POUCHLIQUID56
0220-9309-09SleepCalm Kids15 in 1 POUCHLIQUID156
0220-9309-09SleepCalm Kids1 in 1 BOXLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9309SLEEPCALM KIDS (MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM) LIQUID [BOIRON]6Current NDC, Legacy NDC, 3 package rows20240814_aef7b774-355a-3fb8-e053-2a95a90a268c.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
SleepCalm KidsMATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUMBoironaef7b774-355a-3fb8-e053-2a95a90a268c2024-08-09Exact identifier
ndc (product): 0220-9309

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-9309-07002209309075 LIQUID in 1 POUCH (0220-9309-07) 5 liquid2023-04-26NoNoCurrent
0220-9309-09002209309091 POUCH in 1 BOX (0220-9309-09) / 15 LIQUID in 1 POUCH1 pouch2020-09-100000-00-00NoNoCurrent