Home NDC 83324-335 Quality Choice
Product NDC 83324-335
11-digit product format 833240335
Labeler code 83324
Product ID 83324-335_3d02651a-0fb7-6954-e063-6294a90aa9ef
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form EMULSION
Route ORAL
Labeler QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-01
Substance DIMETHICONE, UNSPECIFIED
Active strength 20 mg/.3mL
Pharmacologic classes Skin Barrier Activity [PE]
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 Quality Choice
Brand name suffix Infants Gas Relief Dye Free
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 20 mg/.3mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198857 Internal RxNorm lookup
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 83324-335-01 Quality ChoiceInfants Gas Relief Dye Free 30 mL in 1 BOTTLE, DROPPER EMULSION 30 1 83324-335-01 Quality ChoiceInfants Gas Relief Dye Free 1 in 1 CARTON EMULSION 1 1
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 5 of 13 · 242 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83324-335-01 83324033501 1 BOTTLE, DROPPER in 1 CARTON (83324-335-01) / 30 mL in 1 BOTTLE, DROPPER 2025-08-01 No No Current