FDA.reportPublic FDA data

Comfort for Colic

Product NDC
64616-116
11-digit product format
646160116
Labeler code
64616
Product ID
64616-116_462f5bc0-eea3-2be8-e063-6294a90a958d
Type
HUMAN OTC DRUG
Nonproprietary name
Comfort for Kids
Dosage form
LIQUID
Route
ORAL
Labeler
Vitality Works, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-07-05
Substance
AETHUSA CYNAPIUM; CHAMOMILE; CITRULLUS COLOCYNTHIS FRUIT; DIOSCOREA VILLOSA TUBER; MAGNESIUM PHOSPHATE, DIBASIC; PULSATILLA PRATENSIS
Active strength
4; 4; 4; 6; 6; 4 [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Comfort for Colic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AETHUSA CYNAPIUM4 [hp_X]/.05mL
CHAMOMILE4 [hp_X]/.05mL
CITRULLUS COLOCYNTHIS FRUIT4 [hp_X]/.05mL
DIOSCOREA VILLOSA TUBER6 [hp_X]/.05mL
MAGNESIUM PHOSPHATE, DIBASIC6 [hp_X]/.05mL
PULSATILLA PRATENSIS4 [hp_X]/.05mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM6936L953C, FGL3685T2X, 0E49E3V9U6, IWY3IWX2G8, A1Y870209Z, 8E272251DI

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-116-01Comfort for Colic30 mL in 1 BOTTLE, DROPPERLIQUID308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-116COMFORT FOR COLIC (COMFORT FOR KIDS) LIQUID [VITALITY WORKS, INC.]7Current NDC, Legacy NDC, 1 package rows20241212_220209c1-18ab-1b78-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-116-016461601160130 mL in 1 BOTTLE, DROPPER (64616-116-01) 30 ml2016-01-140000-00-00NoNoCurrent