Home NDC 83324-335-01 Quality Choice
Product NDC 83324-335
Requested package NDC 83324-335-01
11-digit product format 833240335
Labeler code 83324
Product ID 83324-335_53db3f01-8e2d-43c1-a63b-a5c0d872236c
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 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 Quality Choice
Brand name suffix Infants Gas Relief Dye Free
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 20 mg/.3mL
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 1 of 12 · 236 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