FDA.reportPublic FDA data

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
IngredientStrength
DIMETHICONE, UNSPECIFIED20 mg/.3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198857Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
841b85ef-2ac8-4dac-8659-cffb7e1b1e05Available on FDA.report

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

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 13 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
application number: M002
Anti-GasSIMETHICONEMarc Glassman, Inc.e99f2041-2543-4331-9f54-9eea179f94d22020-10-06WarningsExact identifier
application number: M002

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, DROPPER2025-08-01NoNoCurrent