FDA.reportPublic FDA data

SIMETHICONE

Product NDC
73581-302
11-digit product format
735810302
Labeler code
73581
Product ID
73581-302_50250112-933d-ffb1-e063-6394a90aaafb
Type
HUMAN OTC DRUG
Nonproprietary name
SIMETHICONE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
YYBA
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-01
Substance
DIMETHICONE
Active strength
125 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SIMETHICONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198852

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73581-302-36SIMETHICONE365 in 1 BOTTLECAPSULE, LIQUID FILLED3651

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSN50250112-933c-ffb1-e063-6394a90aaafb1
198852simethicone 125 MG Oral CapsuleSCD50250112-933c-ffb1-e063-6394a90aaafb1
198852dimethicone 125 MG Oral CapsuleSY50250112-933c-ffb1-e063-6394a90aaafb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73581-302-3673581030236365 CAPSULE, LIQUID FILLED in 1 BOTTLE (73581-302-36) 2026-04-01NoNoCurrent