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

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
IngredientStrength
DIMETHICONE, UNSPECIFIED20 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198857

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-335-01Quality ChoiceInfants Gas Relief Dye Free30 mL in 1 BOTTLE, DROPPEREMULSION301
83324-335-01Quality ChoiceInfants Gas Relief Dye Free1 in 1 CARTONEMULSION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN841b85ef-2ac8-4dac-8659-cffb7e1b1e051
198857simethicone 66.7 MG/ML Oral SuspensionSCD841b85ef-2ac8-4dac-8659-cffb7e1b1e051
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY841b85ef-2ac8-4dac-8659-cffb7e1b1e051
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY841b85ef-2ac8-4dac-8659-cffb7e1b1e051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-335-01833240335011 BOTTLE, DROPPER in 1 CARTON (83324-335-01) / 30 mL in 1 BOTTLE, DROPPER2025-08-01NoNoHistorical