Home NDC 64616-113 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 Ingredient Strength ORNITHOGALUM UMBELLATUM 7 [hp_X]/mL IMPATIENS GLANDULIFERA FLOWER 7 [hp_X]/mL CLEMATIS VITALBA WHOLE 7 [hp_X]/mL HELIANTHEMUM NUMMULARIUM FLOWER 7 [hp_X]/mL PRUNUS CERASIFERA FLOWER 7 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 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 64616-113-01 CalmEase Rescue Remedy 30 mL in 1 BOTTLE, DROPPER LIQUID 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64616-113 CALMEASE RESCUE REMEDY LIQUID [VITALITY WORKS] 6 Current NDC, Legacy NDC, 1 package rows 20241212_5fb2ddea-169e-3749-e053-2991aa0a76e4.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 64616-113-01 64616011301 30 mL in 1 BOTTLE, DROPPER (64616-113-01) 30 ml 2010-01-22 0000-00-00 No No Current