FDA.reportPublic FDA data

Calm Mood Kids

Product NDC
51393-5009
11-digit product format
513935009
Labeler code
51393
Product ID
51393-5009_4bd961cd-7093-bdc1-e063-6394a90a4efc
Type
HUMAN OTC DRUG
Nonproprietary name
avena sativa top, angelica archangelica root, holy basil leaf, passiflora edulis flower, scutellaria lateriflora whole, verbena hastata top, and macropiper methysticum root
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Forces of Nature
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-11-01
Substance
ANGELICA ARCHANGELICA ROOT; AVENA SATIVA TOP; HOLY BASIL LEAF; MACROPIPER METHYSTICUM ROOT; PASSIFLORA EDULIS FLOWER; SCUTELLARIA LATERIFLORA WHOLE; VERBENA HASTATA TOP
Active strength
12; 6; 12; 12; 12; 12; 12 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calm Mood Kids
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVENA SATIVA TOP12 [hp_X]/100mL
ANGELICA ARCHANGELICA ROOT6 [hp_X]/100mL
HOLY BASIL LEAF12 [hp_X]/100mL
PASSIFLORA EDULIS FLOWER12 [hp_X]/100mL
SCUTELLARIA LATERIFLORA WHOLE12 [hp_X]/100mL
VERBENA HASTATA TOP12 [hp_X]/100mL
MACROPIPER METHYSTICUM ROOT12 [hp_X]/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ZX4OXU3N6Internal UNII lookup
DTN01M69SNInternal UNII lookup
SCJ765569PInternal UNII lookup
SY49TH8VUAInternal UNII lookup
7BP4DH5PDCInternal UNII lookup
CMJ753697IInternal UNII lookup
BOW48C81XPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42667dd3-b4f6-43d8-8234-42bdbacedd41Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51393-5009-1Calm Mood Kids10 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS102
51393-5009-1Calm Mood Kids1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51393-5009CALM MOOD KIDS (AVENA SATIVA TOP, ANGELICA ARCHANGELICA ROOT, HOLY BASIL LEAF, PASSIFLORA EDULIS FLOWER, SCUTELLARIA LATERIFLORA WHOLE, VERBENA HASTATA TOP, AND MACROPIPER METHYSTICUM ROOT) SOLUTION/ DROPS [FORCES OF NATURE]1Current NDC, Legacy NDC, 2 package rows20221101_42667dd3-b4f6-43d8-8234-42bdbacedd41.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
Calm Mood KidsAVENA SATIVA TOP, ANGELICA ARCHANGELICA ROOT, HOLY BASIL LEAF, PASSIFLORA EDULIS FLOWER, SCUTELLARIA LATERIFLORA WHOLE, VERBENA HASTATA TOP, AND MACROPIPER METHYSTICUM ROOTForces of Nature42667dd3-b4f6-43d8-8234-42bdbacedd412026-02-27WarningsExact identifier
ndc (product): 51393-5009

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51393-5009-1513935009011 BOTTLE, DISPENSING in 1 CARTON (51393-5009-1) / 10 mL in 1 BOTTLE, DISPENSING2022-11-010000-00-00NoNoCurrent