Home NDC 65197-230 Childrens Emetrol Multi Symptom Upset Stomach Relief
Product NDC 65197-230
11-digit product format 651970230
Labeler code 65197
Product ID 65197-230_6d23c84c-4ccc-4863-8d70-e03300ccb4dd
Type HUMAN OTC DRUG
Nonproprietary name Childrens Emetrol Multi-Symptom Upset Stomach Relief
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler WellSpring Pharmaceutical Corporation
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-15
Substance CALCIUM CATION; DIMETHICONE
Active strength 400; 40 mg/1; mg/1
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Childrens Emetrol Multi Symptom Upset Stomach Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CATION 400 mg/1 DIMETHICONE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2M83C4R6ZB Internal UNII lookup 92RU3N3Y1O Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 13 · 255 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65197-230-24 65197023024 1 BOTTLE in 1 BOX (65197-230-24) / 24 TABLET, CHEWABLE in 1 BOTTLE 1 bottle 2026-06-15 No No Current