Home NDC 64616-116 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 PULSATILLA PRATENSIS; AETHUSA CYNAPIUM; DIOSCOREA VILLOSA TUBER; MAGNESIUM PHOSPHATE, DIBASIC; CHAMOMILE; CITRULLUS COLOCYNTHIS FRUIT
Active strength 4; 4; 6; 6; 4; 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Comfort for Colic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PULSATILLA PRATENSIS 4 [hp_X]/.05mL AETHUSA CYNAPIUM 4 [hp_X]/.05mL DIOSCOREA VILLOSA TUBER 6 [hp_X]/.05mL MAGNESIUM PHOSPHATE, DIBASIC 6 [hp_X]/.05mL CHAMOMILE 4 [hp_X]/.05mL CITRULLUS COLOCYNTHIS FRUIT 4 [hp_X]/.05mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64616-116-01 Comfort for Colic 30 mL in 1 BOTTLE, DROPPER LIQUID 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64616-116 COMFORT FOR COLIC (COMFORT FOR KIDS) LIQUID [VITALITY WORKS, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20241212_220209c1-18ab-1b78-e054-00144ff8d46c.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64616-116-01 64616011601 30 mL in 1 BOTTLE, DROPPER (64616-116-01) 30 ml 2016-01-14 0000-00-00 No No Current