FDA.reportPublic FDA data

CalmEase Rescue Remedy

Product NDC
64616-113
11-digit product format
646160113
Labeler code
64616
Product ID
64616-113_462f5967-ef13-2778-e063-6294a90ac4b1
Type
HUMAN OTC DRUG
Nonproprietary name
CalmEase Rescue Remedy
Dosage form
LIQUID
Route
ORAL
Labeler
vitality Works
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-01-22
Substance
CLEMATIS VITALBA WHOLE; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER
Active strength
7; 7; 7; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CalmEase Rescue Remedy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLEMATIS VITALBA WHOLE7 [hp_X]/mL
HELIANTHEMUM NUMMULARIUM FLOWER7 [hp_X]/mL
IMPATIENS GLANDULIFERA FLOWER7 [hp_X]/mL
ORNITHOGALUM UMBELLATUM7 [hp_X]/mL
PRUNUS CERASIFERA FLOWER7 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7PH07Z124Q, 51BRR32WPP, AJU5O1A5ZV, 9NS3M2Y78S, 0KD7R09EAS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-113-01CalmEase Rescue Remedy30 mL in 1 BOTTLE, DROPPERLIQUID307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-113CALMEASE RESCUE REMEDY LIQUID [VITALITY WORKS]6Current NDC, Legacy NDC, 1 package rows20241212_5fb2ddea-169e-3749-e053-2991aa0a76e4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-113-016461601130130 mL in 1 BOTTLE, DROPPER (64616-113-01) 30 ml2010-01-220000-00-00NoNoCurrent